Over the past thirty years, over sixty FDA  officials have retired to executive positions with Big Pharma.

FDAOfficialsRetirementListDocumentation - a Partial List:


David Adams


"...pay careful attention to what is happening (with dietary supplements) in the legislative arena...if these efforts are successful, there could be created a class of products to compete with approved drugs that are subject to less regulation than approved drugs...the establishment of a separate regulatory category for supplements could undercut exclusively rights enjoyed by holders of approved drug applications." 

--David Adams, FDA Deputy Commissioner for Policy before the Drug Information Association Annual Meeting, July 12, 1993, _D-C-A Tan Sheet 11_, July 19, 1993 



David Adams, Partner, is Chair of Venable's Food and Drug Group. Mr. Adams represents numerous FDA-regulated entities before the agency, before Congress, and in litigation.



Client Benefits


As chair of Venable’s expanding Food and Drug Group, Mr. Adams is experienced in counseling, advocacy before the agency, private business negotiation, legislative advocacy, and litigation.  Mr. Adams’s extensive experience in the field includes holding a number of senior positions at the FDA, including Associate Chief Counsel for Drugs in the Office of the Chief Counsel and Director of the Policy Development and Coordination Staff in the Office of the Commissioner.


Edward J. Allera


Revolving door between the US Government and Industry... LLP, American Home Products. Edward J. Allera, FDA, Akin, Gump, Strauss, Hauer & Feld, LLP, Johnson & Johnson. Frank J. Donatelli, USAID ...



Client Business Johnson & Johnson

 Total Spent $160,000


Alexander, Donald C

Allera, Edward J

Heimberg, Gary A

Lopez, Jorge Jr

O'Donnell, Kirk

Skladany, Barney J Jr


 New York Pharma Group: Activities: 1997 Topics & Speakers

... the Pharmaceutical Industry MR. EDWARD JOHN ALLERA Partner Akin, Gump,

Strauss, Hauer & Feld, LLP DR. PETER C. RICHARDSON Senior ...

www.nypharmaforum.org/ content/activities/1997topics.html(broken link)



(broken link)

Government Employer

Mr. Edward J. Allera was Associate Chief Counsel for Enforcement at the Food and Drug Administration (FDA) from 1974 to 1978.

Private Sector Employer

Mr. Allera is currently a partner at the law firm of Akin, Gump, Strauss, Hauer & Feld, L.L.P (Washington, D.C. office). Akin Gump's clients include American Home Products, Pfizer, PhRMA, and Warner-Lambert. In 1998, Mr. Allera was an official lobbyist for Johnson & Johnson.


Joseph Arcarese


Joseph S. Arcarese, Vice President, The Food and Drug Law Institute

January 6, 2006 Joseph Arcarese, Meeting Facilitator The Food and Drug Law Institute 1000 Vermont Ave., NWWashington, DC 20005 Dear Mr. Arcarese: Our collective organizations thank you for the opportunity to discuss the unique identification of medical devices with the FDA on October 27, 2005. We appreciate the willingness of the FDA to hear the viewpoint of providers and look forward to continuing to work with the agency on this issue. We agree that the draft summary of the meeting is generally accurate, but want to stress the strong consensus within the provider community on this issue that was evident at the meeting. Our organizations support mandatory unique identification (UID) of medical devices as the transmission and translation of critical data has vast potential for improving patient safety and supply chain efficiency. A compelling patient safety interest lies in requiring identification technology (such as bar codes or RFID tags) for certain medical devices including implantable items like hip/knee prosthetics, stents and CRM pacers. Unique identification technology would facilitate and improve upon the tracking of these devices, especially in the event of a recall orother safety concern. Clearly, UID technology can improve risk management through reductions in supply chain and medical errors. Inventory and warehousing accuracy as well as product movement efficiency may be improved, thereby reducing operating costs. Hospitals are moving forward on the adoption of technology and with the current lack of a national standard have had to invest millions of dollars to create internal tracking systems for devices. It is clear this investment improves quality and supply chain efficiency for the hospital, but a national unique identifier system would accelerate these efforts that ultimately benefit patients. In closing, we strongly encourage the FDA to move toward a mandatory approach for the unique identification of medical devices through the Advance Notice of Proposed Rulemaking regulatory process. We thank you for allowing us to comment on the draftsummary of the meeting to discuss unique device identification. Sincerely, American Hospital AssociationAssociation of American Medical Colleges Bon Secours Health System, Inc. Catholic Health Association Federation of American Hospitals National Association of Public Hospitals and Health Systems NovationPremierVHA, Inc.



Lane asked if the meeting facilitator Joseph Arcarese is with the FDA.  Dennis Byer said that he is with the FDLI which is the Federal Drug Law Institute.  The gentleman in charge from the FDA perspective was Dr. Larry Kessler.  He asked Joe Arcarese to facilitate the meeting. Dr. Kessler did address the audience and laid out some of his concerns.  Joe moderated the discussion.  


John Roberts said that he didn’t think that Joe Arcarese is a FDA representative.  The FDA is not supposed to talk to industry. The FDLI calls meetings on topics and invite the FDA and industry to talk at it.  Joe Arcarese said that he was a former employee of the FDA until he got the current position with the FDLI.  Kathy added that she thought he was a consultant.



Michael Beatrice

Rear Admiral (Ret.) Michael G. Beatrice, Ph.D. Rear Admiral (Ret.) Michael Beatrice was elected Vice President, Corporate Regulatory and Quality Science, Abbott Laboratories by Abbott’s board of directors, effective November 1, 1999. Prior to joining Abbott in his current position, RADM Beatrice was a vice president at Quintiles, in Rockville, Maryland. Before joining Quintiles in 1996, Beatrice, a retired Admiral and Assistant Surgeon General in the United States Public Health Service, was the Deputy Director of FDA’s Center for Biologics Evaluation and Research. His background includes 20 years experience at the FDA, 1 year in the National Institutes of Health (NIH) Product Development Service, a rotational residency at the hospitals of the University of Oklahoma, and practicing pharmacy in both hospital and retail settings. RADM Beatrice serves on the Executive Advisory Council of The College of Integrated Science and Technology at James Madison University and is a Principal Visiting Staff Member at University College, London. In addition he is a charter member of the Association of Food and Drug Administration Alumni Association, a member of the Association of Food and Drug Officials, and serves on the Board of Directors of the Piven Theatre in Evanston, Illinois and the Lookingglass Theatre in Chicago. RADM Beatrice earned a Bachelor’s degree in pharmacy from the University of New Mexico, Albuquerque, a Master’s degree in clinical pharmacy from the University of Oklahoma, Norman, Oklahoma, and a Ph.D. in pharmaceutics from the University of Maryland in Baltimore.




Abbott Names Executive to Lead Global Quality and Regulatory Organization



    ABBOTT PARK, Ill., Oct. 5, 1999 /PRNewswire/ -- Abbott Laboratories (NYSE: ABT)

today announced that its board of directors elected Michael G. Beatrice, vice

president, corporate regulatory and quality science, effective November 1.  In

this capacity, he will report to Miles White, chairman and chief executive


    Beatrice, 51, has 25 years of experience in the field, primarily with the

U.S. Food and Drug Administration (FDA).  Since 1996, he has served as a vice

president at Quintiles.  Previous to this position, Beatrice was with the FDA

for more than 20 years.  At the FDA, he held senior positions in the Center

for Biologics Evaluation and Research (CBER) and the Center for Drug

Evaluation and Research (CDER).  In these roles he held policy development

responsibilities in review, inspection and approval across biological,

biotechnology, drug and device products.

    "Mike's appointment brings Abbott a highly talented and experienced

professional to lead our global quality and regulatory organization," said

Miles White.  "Having served in senior positions with the U.S. Food and Drug

Administration and worked with a number of health care organizations, Mike

brings a valuable perspective that will strengthen this critical aspect of our


    Beatrice is a Ph.D. candidate in pharmaceutical science at the University

of Maryland and holds a master's degree from the University of Oklahoma and a

bachelor's degree from the University of New Mexico.

    Abbott Laboratories is a global, diversified health care company devoted

to the discovery, development, manufacture and marketing of pharmaceutical,

diagnostic, nutritional and hospital products.  The company employs 56,000

people and markets its products in more than 130 countries.  In 1998, the

company's sales and net earnings were $12.5 billion and $2.3 billion,

respectively, with diluted earnings per share of $1.51.

    Abbott's news releases and other information are available on the

company's Web site at http://www.abbott.com.


SOURCE Abbott Laboratories

Web Site: http://www.abbott.com

Company News On Call: Company News On-Call:

http://www.prnewswire.com/comp/110328.html or fax, 800-758-5804,

ext. 110328


James S. Benson, FDA Deputy Commissioner


Director/Chairman of the Board

Cytomedix, Inc.



James S. Benson, a member of the FDAAA board of directors, is also on the board of Medical Device Consultants, “a leading consulting and contract research organization for the medical device industry,” according to the press release announcing his appointment to that company’s board. He was formerly executive vice president for technology and regulatory affairs at AdvaMed (formerly HIMA), which he has described as “a trade association that represents more than 800 manufacturers of medical devices, diagnostic products, and medical information systems.” The press release said Benson was the “lead strategist for the association’s regulatory agenda.”


Robert Brackett- Director, Food Supply & Applied Nutrition, 2004-2007

Senior Vice-President, Grocery Manufacturers Association




Sheldon Bradshaw, FDA Chief Counsel, retires to Hunton and Williams



September 7th, 2007

By Ed Silverman


“There was no official announcement from the agency, at least not as far as we can tell, but Sheldon Bradshaw is joining Hunton & Williams, which has a significant pharmaceutical-industry practice and reps such companies as Pfizer.

Bradshaw succeeded the controversial Dan Troy two years ago and, as predicted, was a mostly stay-the-course kind of chief counsel. Under his watch, for example, the FDA continued to assert that its own regs pre-empt state courts and juries when it comes to deciding whether individuals can mount product-liability lawsuits.”


Robert P. Brady


Hogan & Hartson LLP Robert P. Brady

rpbrady@hhlaw.com PHONE 202.637.6969 FAX 202.637.5910. Robert P. Brady Partner,

Washington, DC As the head of Hogan & Hartson's drug/biotechnology practice group ...

Robert P. Brady

Partner, Washington, D.C. As the head of Hogan & Hartson's drug/biotechnology practice group, Bob Brady focuses his practice on pharmaceutical, biological/biotechnology product law. Bob counsels companies, individuals, and associations on a wide range of legal and regulatory matters involving the U.S. Food and Drug Administration (FDA) and related state and federal agencies. In the areas of pharmaceutical and biological products—including such products derived from biotechnology—he counsels clients on all aspects of product development and clinical investigation; product approvals involving New Drug Applications, Biologics License Applications, and Abbreviated New Drug Applications; product promotion and post-approval requirements, including compliance with Good Manufacturing Practices and safety reporting; and on a wide array of civil and criminal enforcement issues. He counsels companies on all aspects of marketing and promoting over-the-counter drug products as well as cosmetics. He is a frequent writer and speaker on his areas of concentration.

In 1986, after having served as vice president and general counsel for two years, Bob was elevated to the position of executive vice president of the Cosmetic, Toiletry and Fragrance Association. From 1981 to 1983, he served as the executive assistant to the commissioner of the FDA. His government career with the FDA's Office of Chief Counsel began in 1975, when he served in several positions, including associate chief counsel for biologics, associate chief counsel for foods, and associate chief counsel for enforcement.


Associate Chief Counsel for Biologics-FDA, Executive Assistant to the Commissioner of the Food and Drug Administration  Hogan & Hartson, L.L.P.  Genentech 

Government Employer

Mr. Robert P. Brady served in many positions in the US FDA including Associate Chief Counsel for Biologics; Associate Chief Counsel for Foods; and Associate Chief Counsel for Enforcement (1975-1981). From 1981 to 1983, Mr. Brady was Executive Assistant to the Commissioner of the Food and Drug Administration.

Private Sector Employer

Mr. Brady is currently a partner at the law firm of Hogan & Hartson L.L.P. In 1998, Mr. Lawton was a registered lobbyist for Genentech.


Anthony Celeste



For Immediate Release

May 9, 2005


Patty Frank, Investors, (513) 763-1992

Lori Dorer, Media, (513) 345-1685

Kendle’s Anthony C. Celeste Receives

FDA Distinguished Alumni Award

25-Year Veteran of FDA Recognized for

Commitment to Public Health and Safety

CINCINNATI, May 9, 2005 – Kendle (Nasdaq: KNDL), a leading, global full-service clinical research organization, today announced Anthony C. Celeste is one of three recipients of the 2005 FDA Distinguished Alumni Award. Celeste, who has dedicated his 45-year professional life to serving the public and upholding the FDA’s mission and values, received the agency’s highest honor at its annual awards ceremony May 6.

Anthony C. Celeste

Senior Vice President

Kendle Regulatory Affairs

“Tony’s ultimate concern has always been the public’s health and safety,” said Candace Kendle, Chairman and CEO of Kendle. “Throughout his tenure, he’s been viewed as a trusted advisor to biopharmaceutical companies throughout the world as they work to bring their products to the marketplace. This latest award from the FDA may be the crowning accomplishment on Tony’s long list of honors and achievements.”

Celeste spent 25 years with FDA, concluding his career there as director of the agency’s Office of Regional Operations, the unit responsible for managing and directing the field force of investigators, analysts, compliance officers and administrative staff. In this position, he had day to day management responsibility for all field office activities.

Corporate Headquarters

1200 Carew Tower

441 Vine Street

Cincinnati, OH 45202

Tel: 1 800 733 1572 (US only)

Tel: +1 513 381 5550

Fax: +1 513 381 5870


+44 1344 750225


+61 3 9567 7600

Latin America

+52 55 2628 2649


Celeste’s most recent experience has been with AAC Consulting Group, Kendle’s Regulatory Affairs consulting subsidiary in Rockville, Md. He served as President of AAC for more than 20 years and since 2004 has worked as Senior Vice President. While at AAC, Celeste has been involved in the full range of FDA-regulated products and practices and has provided assistance to companies regarding enforcement, strategic planning for regulatory compliance, interpretation of Good Manufacturing Practices (GMPs) and many other issues.

Celeste is the previous recipient of several FDA honors and awards of merit, including the Distinguished Service and Leadership Award from the Food and Drug Law Institute (FDLI). He has published several papers on regulatory topics and is co-author of Application of Pharmaceutical cGMPs, published by FDLI. In addition, he is writing How to Prepare for an FDA Inspection, due for release during 2005, as part of a six-book series published by FDAnews.

About Kendle

Kendle International Inc. (Nasdaq: KNDL) is among the world’s leading global clinical research organizations. We deliver innovative and robust clinical development solutions – from first-in-human studies through market launch and surveillance – to help the world’s biopharmaceutical companies maximize product life cycles and grow market share. With the expertise of our more than 1,700 associates worldwide, Kendle has conducted clinical trials or provided regulatory, pharmacovigilance and validation services in 70 countries. Investor kits are available upon request from Kendle, 1200 Carew Tower, 441 Vine Street, Cincinnati, OH 45202, or from the company’s Web site at www.kendle.com.



Anthony C. Celeste

Senior Vice President


All AAC clients will benefit from Tony Celeste’s 25 years of regulatory experience with the Food and Drug Administration and an additional 20 years of consulting experience as President of AAC Consulting Group. From FDA tours of duty in New York, Kansas City, Detroit, Boston, Cincinnati and Washington, DC and his leadership of AAC for the last two decades, Mr. Celeste has regulatory and consulting experience that you will find invaluable.


He assumed increasingly more responsible leadership position throughout his FDA career including serving as Chief Chemist and District Director in various FDA District Offices before transferring to FDA Headquarters in 1976. There he rose to assume responsibility for all of FDA’s field force of investigators, analysts, compliance officers and administrative staff in his position as Director of the Office of Regional Operations. He has received numerous awards including the FDA Award of Merit, the Commissioner Special Citation Award and the FDLI Distinguished Service and Leadership Award. He is a frequent speaker on regulatory matters and has authored a number of publications including co-authoring the popular FDLI book titled, Application of Pharmaceutical GMPs. 


Mr. Celeste’s experience made him a valuable asset when he assumed the position of President of AAC in 1985. He served in this position until mid-2004, when he relinquished this post to work directly with AAC clients, giving you the direct benefit of his extensive regulatory knowledge.


Tel: 301 838 3120 ext. 122

Fax: 301 838 3182

Email: aceleste@aacgroup.com


Lester Crawford - FDA Commissioner, 2005

Policy Directions, Inc - lobbies Congress and FDA for drug companies





Richard Crout


In an  interview in January 1982, Dr. Richard J. Crout of the FDA, revealed the FDA's motive for targetting Dr. Burzynski for destruction: "I never have and never will approve a new drug to an individual, but only to a large pharmaceutical firm with unlimited finances," declared Dr. Crout. The next year, the FDA began its vendetta against Burzynski, an individual with limited finances. [fbu2]



Biopure Corporation (ticker: BPUR, exchange: NASDAQ) News Release - 1/16/2002

Biopure Appoints Dr. J. Richard Crout to Board of Directors

CAMBRIDGE, Mass., Jan 16, 2002 /PRNewswire via COMTEX/ -- Biopure Corporation (Nasdaq: BPUR) today announced the appointment of J. Richard Crout, M.D. to the company's Board of Directors. Dr. Crout brings to Biopure a wealth of professional experience in academic medicine, government and industry, including positions at the U.S. Food and Drug Administration (FDA) and the National Institutes of Health (NIH).

"Dr. Crout's vast experience in all facets of drug development are a great resource for the company," said Biopure Chairman and CEO Carl W. Rausch. "We're pleased that he agreed to join our Board."

As president of Crout Consulting, Dr. Crout advises pharmaceutical and biotechnology companies on the development and regulation of new products. From 1963 to 1971 he was head of clinical pharmacology at the University of Texas Southwestern Medical School and then at Michigan State College of Human Medicine. In 1971 he joined the FDA, serving as Director of the Bureau of Drugs from 1973 to 1982, for which he was awarded the Distinguished Service Medal of the U.S. Public Health Service. For the next two years he headed the NIH Office of Medical Applications of Research. From 1984 through 1993 he served as Vice President, Medical and Scientific Affairs, at Boehringer Mannheim Pharmaceuticals.

Dr. Crout has been a director of Genetics Institute and GelTex Pharmaceuticals and currently serves on the corporate boards of Trimeris, Inc. and Genelabs Technologies, Inc. and on the scientific advisory board of CellPath, Inc.




 Biopure Corporation (ticker: BPUR, exchange: NASDAQ Stock Exchange (.O)) News Release - 1/16/2002


Biopure Appoints Dr. J. Richard Crout to Board of Directors


CAMBRIDGE, Mass., Jan 16, 2002 /PRNewswire via COMTEX/ -- Biopure Corporation (Nasdaq: BPUR) today announced the appointment of J. Richard Crout, M.D. to the company's Board of Directors. Dr. Crout brings to Biopure a wealth of professional experience in academic medicine, government and industry, including positions at the U.S. Food and Drug Administration (FDA) and the National Institutes of Health (NIH).

"Dr. Crout's vast experience in all facets of drug development are a great resource for the company," said Biopure Chairman and CEO Carl W. Rausch. "We're pleased that he agreed to join our Board."


As president of Crout Consulting, Dr. Crout advises pharmaceutical and biotechnology companies on the development and regulation of new products. From 1963 to 1971 he was head of clinical pharmacology at the University of Texas Southwestern Medical School and then at Michigan State College of Human Medicine. In 1971 he joined the FDA, serving as Director of the Bureau of Drugs from 1973 to 1982, for which he was awarded the Distinguished Service Medal of the U.S. Public Health Service. For the next two years he headed the NIH Office of Medical Applications of Research. From 1984 through 1993 he served as Vice President, Medical and Scientific Affairs, at Boehringer Mannheim Pharmaceuticals.


Dr. Crout has been a director of Genetics Institute and GelTex Pharmaceuticals and currently serves on the corporate boards of Trimeris, Inc. and Genelabs Technologies, Inc. and on the scientific advisory board of CellPath, Inc.


Biopure Corporation


Biopure Corporation, headquartered in Cambridge, Mass., is a leading developer, manufacturer and supplier of a new class of pharmaceuticals, called oxygen therapeutics, which are intravenously administered to deliver oxygen to the body's tissues. Hemopure(R) [hemoglobin glutamer - 250 (bovine)], or HBOC-201, is approved in South Africa for the treatment of adult surgical patients who are acutely anemic and for the purpose of eliminating, reducing or delaying the need for allogenic red blood cells in adult surgical patients. The company is preparing to file a marketing application for Hemopure in the United States, followed by an application in Europe, for perioperative use of the product in patients undergoing elective surgery. The product is also being developed for use in trauma, cancer and ischemic events such as heart attack and stroke. Oxyglobin(R) [hemoglobin glutamer - 200 (bovine)], the only product of its kind approved by the U.S. FDA and the European Commission, is commercially available in the United States, Germany, France and the United Kingdom for the treatment of anemia in dogs.


Statements in this press release that are not strictly historical may be forward-looking statements. There can be no assurance that Biopure Corporation will be able to commercially develop its oxygen therapeutic products, that necessary regulatory approvals will be obtained, that anticipated milestones will be met in the expected timetable, that any clinical trials will be successful, or that any approved product will find market acceptance and be sold in the quantities anticipated. Actual results may differ from those projected in forward-looking statements due to risks and uncertainties that exist in the company's operations and business environment. These risks include, without limitation, the company's stage of product development, history of operating losses and accumulated deficits, and uncertainties and possible delays related to clinical trials, regulatory approvals, possible healthcare reform, manufacturing capacity, marketing, market acceptance, competition and the availability of sufficient financing to support operations. The company undertakes no obligation to release publicly the results of any revisions to these forward-looking statements to reflect events or circumstances arising after the date hereof. A full discussion of Biopure's operations and financial condition, and specific factors that could cause the company's actual performance to differ from current expectations, can be found on the company's website at www.biopure.com/corporate/legal/home_legal.htm and in the company's filings with the U.S. Securities and Exchange Commission, which can be accessed in the EDGAR database at the SEC website, www.sec.gov, or through the Investor section of Biopure's website, www.biopure.com.


SOURCE Biopure Corporation


CONTACT: Douglas Sayles, Director Corporate Communications of Biopure Corporation, +1-617-234-6826, PR@biopure.com; or Brad Miles (media) of BMC Communications, +1-212-477-9007 ext. 17; or Jonathan Fassberg (investors) of The Trout Group, +1-212-477-9007 ext. 16




Head of Drug Regulation at FDA and Its Predecessors

J. Richard Crout, MD, 1973-1981


Harry M. Meyer, Jr., MD, 1982-1986 Paul D. Parkman, MD, 1987 Carl C. Peck, MD,  1988-1993 Janet Woodcock, MD, 1994-present


Paul N. D'Eramo



Immediate Past Chairman

Paul N. D'Eramo is Executive Director, Quality and Compliance Worldwide for Johnson & Johnson. In that position, he is responsible for regulatory outreach and compliance oversight for the Johnson & Johnson family of companies. His compliance role involves partnering with the operating companies to resolve quality and regulatory compliance issues, and supporting initiatives involving new facilities, new products, and regulatory inspections.

As part of his outreach duties, D'Eramo works with industry trade associations and regulatory agencies to develop new guidelines and regulations. He is a member of the ISPE Executive Council and the GAMP® Board of Directors, and is past chair of the Technical Documents Steering Committee. D'Eramo has been a speaker at numerous ISPE conferences in the U.S., Europe, and Asia, and has published articles in industry journals. He has also made presentations at other industry symposia and has organized several joint industry/FDA training initiatives.


Before joining J&J in 1997, D'Eramo worked for the FDA for 20 years as an investigator, compliance officer, regional drug specialist and manager of the Regional Pre-Approval Inspection Program. While at FDA, he was instrumental in forming the partnership between ISPE and the FDA which lead to the creation of the Baseline® Pharmaceutical Engineering Guides and the SUPAC "Similar Equipment" Addendum. For these efforts, he was awarded the ISPE Professional Achievement Award and Vice President Al Gore's “Hammer Award” in 1997.


D'Eramo received his BS in pharmacy from Rutgers College of Pharmacy and is a registered Pharmacist in New Jersey.



Charles Edwards


Molecular Biosystems

Edwards was a director of Molecular Biosystems Inc. in 2000, a firm with large investments by the State of Wisconsin Investment Board (19.37%) and Mallinckrodt Group Inc. (7.00%).

Molecular Biosystems 2000 DEF14A / Securities and Exchange Commission



Board of Directors / Materia Inc.

Edwards is on the Board of Directors of Materia Inc.





12/13/69 - 3/15/73


Charles C. Edwards, the son of a country doctor, was born in Overton, Nebraska in 1923. He transferred from Princeton to the University of Colorado, where he received both his B. A. and, in 1948, his M. D. degree. Edwards' surgical residency at the University of Minnesota as a Mayo Foundation fellow was interrupted from 1950 to 1952 by his service as a medical officer with the Marines in the Korean War. In 1956 he received the M. S. in surgery from Minnesota. During the following five years he was engaged in private surgical practice in Des Moines, Iowa, including positions on the teaching staffs of two area hospitals. In 1961 Edwards assumed a surgical faculty position at Georgetown University Hospital; at this time he also served as a consultant to the U. S. Public Health Service. He moved to Chicago in 1962 to join the staff of the American Medical Association, where he was assistant director for medical education and hospitals and, in 1965, director of the division of socio-economics. Two years later Edwards remained in Chicago but became vice-president for health and scientific affairs of the management firm, Booz, Allen, and Hamilton.

In December 1969 HEW Secretary Robert H. Finch named Edwards Commissioner of Food and Drugs. He remained at FDA until March 1973, a period of upheaval on many fronts for the agency. For example, FDA's organization shifted from a functional orientation to product areas; the agency budget doubled from 1970 to 1972; FDA was assigned responsibility for regulating biologics and radiological health; and cancer-linked cyclamates, botulism-suspected Bon Vivant vichyssoise, and mercury-tainted swordfish and tuna were at least temporarily taken off the market in massive operations. President Nixon nominated Edwards to assume the position of Assistant Secretary for Health in the Department of HEW, the Senate confirmed his appointment, and Edwards began that position in April 1973. As assistant secretary, Edwards reorganized some components of the Public Health Service, such as giving greater standing to the Centers for Disease Control, and he aroused the ire of his former colleagues at the AMA when he proposed major reforms in national health care.


Edwards left government service in 1975 and became an executive with a medical device firm. In 1977 he was appointed president and chief executive officer of the Scripps Clinic and Research Foundation in La Jolla, California; in 1991 he assumed his present position as president and CEO of the Scripps Institutes for Medicine and Science. His honors include the Distinguished Service Award from the Department of HEW and an honorary degree from the Philadelphia College of Pharmacy and Science. In 1990 HHS Secretary Louis Sullivan named Edwards to head the Advisory Committee on the Food and Drug Administration to review the agency's mission, structure, priorities, staffing, and budget.



Michael A. Friedman


The Old Revolving Door

Michael A. Friedman, M.D. . . former acting commissioner of the United States Food and Drug Administration (FDA) Department of Health and Human Services . . .now senior vice-president for clinical affairs at G. D. Searle & Co., a pharmaceutical division of Monsanto Corporation.



Sherwin Gardner


…Dr. Olney's objections were overruled by acting FDA Commissioner Sherwin Gardner and the panelists

who he objected to was assigned to study the issue of aspartic acid toxicity.

 Sherwin Gardner was the Deputy FDA Commissioner in 1979. In July, 1974, he had signed the initial approval for aspartame's use in dry foods. (This initial approval was later blocked by objections from James Turner, Esq. and Dr. John Olney. In December, 1979, Sherwin Gardner became a Vice President of Grocery Manufacturers of America, Inc. (GAO 1986).



Between 1979 and 1982, four more FDA officials who participated in the approval process took jobs linked to the NutraSweet industry: Pape; acting FDA commissioner Sherwin Gardner; Albert Kolbye, who was

associate director of the Bureau of Foods for toxicology, and Mike Taylor, an FDA lawyer who represented the bureau before the Board of Inquiry. All four denied any conflict of interest.


GAO Report July 1986


James Goddard


FDA Commissioner (in the 1960's) James Goddard…

A few years after leaving the FDA Goddard became Chairman of the board of Ormont Drug and Chemical company.



Mark Goldberger, Director of the Office of Antimicrobial Products - 2007




Jere E. Goyan


Jere E Goyan, Ph.D.

Chairman of the Board at

SciClone Pharmaceuticals


Officer since July 1997

Director since January 1992    

Jere E. Goyan, Ph.D. has been Chairman of our Board of Directors since July 1997 and one of our directors since January 1992. Currently, Dr. Goyan is President of Goyan & Hart Associates, a private consulting firm. From May 1993 until December 1998, Dr. Goyan was President, Chief Operating Officer, and a director of Alteon, Inc., a biotechnology company. He also served Alteon as Acting Chief Executive Officer from July 1993 until May 1994 and as Senior Vice President for Research and Development from January 1993 to May 1993. Dr. Goyan was the Commissioner of the United States Food and Drug Administration from October 1979 to January 1981. He was Dean of the School of Pharmacy at the University of California, San Francisco ( UCSF ) and Professor of Pharmacy and Pharmaceutical Chemistry from 1967 through 1992. He joined the faculty of UCSF in 1963 as an associate professor after serving on the faculty of the University of Michigan, College of Pharmacy from 1956 to 1963. Dr. Goyan also currently serves as a director of Penwest Pharmaceuticals Co. and as a consultant to various companies and corporations.






James D. Grant


Mr. Grant became a director of Targeted Genetics in 1993. He has had a remarkable career, making contributions in both the public and private sector. From 1986 to 1992, he served as Chief Executive Officer of T Cell Sciences, Inc., a biotechnology company, remaining as Chairman of the Board until his retirement in 1997. Previously, Mr. Grant was Vice President of CPC International, Inc., a multinational food and industrial products company, from 1972 to 1986. He served as Deputy Commissioner of the Food and Drug Administration (FDA) from 1969 to 1972 and was Vice Chairman of the Advisory Committee on the FDA from 1990 to 1991. Before his death, Mr. Grant had also served as a director of Blue Planet Biotech Fund, a U.K.-based unit trust. He previously served as a director of Zynergy Group Limited, a U.K-based medical device company, and several biotechnology companies.


Gerald Guest


This dual role also manifested itself in other ways. In an apparent attempt to quell public controversy over rBGH, for example, two FDA researchers published industry and "independent" data in the journal Science in 1990 to show that rBGH was safe for consumers)' Gerald Guest, the director for FDA's Center for Veterinary Medicine told Science, "We'd like to get our side of the story out, to show why we're comfortable with the safety. We'd like for people to know that its a thoughtful process and we want it to be open and credible”

Guest was apparently doing a lot of wishful thinking. Professor Samuel Epstein criticized the FDA for acting "as a booster or advocate for an animal drug that hasn't yet been approved." Epstein and others faulted the FDA for including only pieces of unpublished studies about rBGH in the Science article but not making the full studies available for independent review.34



Royer Biomedical, Inc.

... He advises the Company regarding its third party manufacturing. Gerald Guest, DVM.

Senior Advisor, Consultant, and member RAH Board of Directors. ...

Management and Advisors

Gerald Guest, DVM

Senior Advisor, Consultant, and member RAH Board of Directors. Dr. Guest is the former Director of the Center for Veterinary Medicine (CVM) at the FDA.


 www.fda.gov/ohrms/dockets/ dailys/01/Feb01/022001/cr00001.pdf

Dr. Gerald Guest

Consultant to Royer Biomedical Inc.



Marlene Haffner –Head, FDA Orphan Products Office, 1971-2006

Executive Director RegulatoryAffairs, Amgen


FDA's Orphan Drugs Czar to Join Amgen


Marlene Haffner, the long-time head of the Food and Drug Administration's orphan products office, has retired from the agency after 35 years to take a job with Amgen, the nation's biggest biotech firm. Amgen was one of the first companies to take advantage of the seven years of market exclusivity granted under the Orphan Drug Act, which is given to firms that are first to market a drug for treating conditions with fewer than 200,000 patients. Amgen's Epogen, now taken by more than 300,000 Medicare-reimbursed dialysis patients, racked up $2.5 billion in sales last year. When she joins Amgen on Jan. 1, Haffner's new title will be Executive Director of Regulatory Affairs for Global Government Affairs. Three years ago, FDA whistleblower Robert F. Steeves accused Haffner of taking numerous wasteful and fraudulent overseas trips at government expense. In a suit filed in a Virginia federal district court, Steeves, now a private consultant, accused Haffner of making false charges and improperly suspending him from the agency after he made those allegations, which have never been investigated by FDA's top management, according to FDAWebview (subscription required). On the other hand, Abbey Meyers, president of the National Organization of Rare Diseases, praised Haffner's tenure at FDA, but expressed "surprise that she's going somewhere where they don't really focus on orphan drugs."


Jerome Halperin


The FDAAA’s treasurer and chairman of the finance committee, Jerome A. Halperin, is president and CEO of the Food and Drug Law Institute (FDLI). FDLI’s web site says its “500+ members comprise manufacturers and suppliers of medicines . . . medical devices, food and cosmetics . . . law firms, consulting firms, associations, and others.”… Halperin was formerly vice president of technology for CIBA-GEIGY (now Novartis) and in 2001 was appointed to the board of directors of PharmQuest, which provides software to accelerate drug development.



IMS Announces Appointment of Experts to its Scientific Advisory Board

Board to Accelerate Development of Axenohl™Markets

JEROME HALPERIN, RPH, is an internationally recognized expert on drugs and their applications in humans and animals.  Mr. Halperin recently retired as Chief Executive Officer of USP.  Prior to joining USP, Mr. Halperin served as Vice President Technology for CIBA-Geigy’s Consumer Pharmaceutical Division.  Mr. Halperin was also previously in the commissioned Corps of the US Public Health Service for 25 years, including 12 years with the FDA.  When Mr. Halperin retired from the US Public Health Service in 1983, he was a Rear Admiral and Deputy Director of the Bureau of Drugs.




PharmQuest Corporation Appoints Jerome A. Halperin to its Board of Directors


SAN JOSE CA, April 19, 2001--PharmQuest Corporation announced today the appointment of Jerome A. Halperin to its Board of Directors.


Mr. Halperin will become President and CEO of the Food and Drug Law Institute (FDLI), a not-for-profit educational organization dedicated to advancing public health, effective July 1, 2001. Prior to joining FDLI, he was the chief executive at The United States Pharmacopeia (USP) and spent six years in the pharmaceutical industry as Vice President- Technology for CIBA Consumer Pharmaceuticals, a division of CIBA-GEIGY, Inc., now Novartis (NYSE: NVS). Mr. Halperin served as a commissioned officer in the U.S. Public Health Service for 25 years, retiring from government service in 1983 as Acting Director of the FDA's Office of Drugs in the combined National Center of Drugs and Biologics. He is the 2001 Remington Honor Medalist of the American Pharmaceutical Association and the recipient of the 2001 Distinguished Service Award of the Drug Information Association. Mr. Halperin earned a Bachelor of Science in Pharmacy from Rutgers, The State University of New Jersey; a Master of Public Health from The Johns Hopkins School of Hygiene and Public Health; and a Master of Science in Management from the Massachusetts Institute of Technology.


Shankar Hemmady, President and CEO of PharmQuest noted, "We are honored to have Mr. Halperin join PharmQuest's Board of Directors. His wealth of public health experience and his leadership in a number of government agencies and professional organizations are invaluable to PharmQuest as we bring together drug development software solutions in compliance with the latest regulatory guidelines and international standards.''


"I am very pleased to become part of the PharmQuest organization," added Mr. Halperin. "PharmQuest is at the leading edge of using the Internet Technology as a medium for solutions to assure that pharmaceutical and biological products and the systems used to develop, test, manufacture, package and label them are in full compliance with the cGMP regulations (current Good Manufacturing Practices) of the United States Food and Drug Administration (FDA). This technology will save time and expense while providing consumers with the comfort of knowing their medicines are of the highest quality."


About PharmQuest


PharmQuest collaborates with the Pharmaceutical & Biotechnology Industries to provide software that significantly improves efficiency and compliance in the product development process. PharmQuest's standards-based, open-architecture Product Development Management System is optimized for the unique requirements of the industry. This system employs an integrated family of applications facilitating workflow automation, process mapping, expert systems and knowledge bases that maximize scientists' time and resources in Pre-clinical Development and Chemistry, Manufacturing & Controls (CMC). As a result, PharmQuest has forged major partnerships with the FDA's Center for Drug Evaluation & Research, three of the top twenty Pharmaceutical companies, the Parenteral Drug Association, International Pharmaceutical Excipients Council, the University of California, San Francisco and the University of Iowa.



Melanie Chawathe

PharmQuest Corporation







May 01, 2003  CONTACT: Jeff Ezell 202-434-7243


Arthur Hull Hayes


WASHINGTON (UPI) Pouring over laboratory rat studies in the spring of 1981 in the government’s final safety review of a new artificial sweetener, senior statistician Satya Dubey of the Food and Drug Administration was troubled.Dubey, a member of a special FDA "commissioner’s team" formed to help decide the fate of

the product to be known as NutraSweet, wrote an internal memo that brain tumor data from the rat tests was so

"worrisome" that he could not recommend approval. Two other statisticians on the six-member team agreed with Dubey that the Chicago-based G.D. Searle Co. had not proved with "reasonable certainty" the safety of the sweetener, known generically as aspartame. A 1980 Public Board of Inquiry had voted 3-0 to ban aspartame because of similar fears. But a few weeks later on July 18, 1981, new FDA Commissioner Arthur Hull Hayes, Jr., a pharmacologist who had been in office less than three months and had little background in food additives, overturned the board and approved the use of aspartame in dry foods….

In late 1982, Searle petitioned for FDA approval to use the sweetener in diet soft drinks and children’s vitamins. On a day when Hayes was away, Novitch approved the petition, increasing the acceptable daily intake level for humans by nearly half, from 34 mg to 50 mg per kilogram of body weight. Novitch, now in private industry, said he and Hayes had worked together on the matter, but declined to say why he was left to sign the approval.

Just weeks later, Hayes resigned under the cloud of an internal Dept. of Health and Human Services investigation into his acceptance of gratuities from FDA-regulated companies ­ including free rides aboard jets owned by a major NutraSweet user, the General Foods Corp.

Shortly after being named Dean of the New York Medical school, Hayes also became a consultant to the New York-based public relations firm of Burson-Marsteller, which represents the NutraSweet Co. and several major users.  Hayes’ former top spokesman, Wayne Pines, who previously had joined the firm, said he approached Hayes because he thought him "an added value" to clients. Hayes, now president of the E.M. Pharmaceutical Co. in Hawthorne, N.Y., declined comment for this series of articles. He has in the past denied any impropriety in his consulting role, which sources said paid him more than $1000 per day.

Burson-Marsteller vice president, Buck Buchwald stressed that Hayes was not involved in NutraSweet issues and worked but 10 to 15 days a year. But a former Burson-Marsteller employee, who requested anonymity, said Hayes was hired precisely because of his decision on NutraSweet and other issues affecting company clients.


GAO Report July 1986


Jane Henney


U of Cincinnati

boards of directors in the health care field, including the Commonwealth Fund in New York City, the Scripps Research Institute in La Jolla, AmerisourceBergen Corporation in Philadelphia, AstraZeneca PLC in London, the Science Board of MPM.Capital in Boston, and the Advisory Group to the Pew Science and Society Institute.




Charles P. Hoiberg


International Society of Pharmaceutical Engineering

Secretary, ISPE

Charles P. Hoiberg, PhD, is the Executive Director for Global Regulatory Portfolio and Projects in Pfizer's Global Regulatory CMC and QA Group. He received a BS in chemistry from the College of William and Mary and a PhD in biochemistry (chemistry minor) from Pennsylvania State University. He worked for more than eight years at Sterling Drug Inc. in R&D before joining the FDA. Dr. Hoiberg had a leadership role and held numerous positions in the Agency and was involved in numerous global initiatives. When he retired from the Agency, he was the Deputy Director of the Office of New Drug Chemistry



Peter Honig


Peter Honig left the directorship of Office of Drug Safety (ODS) February 2002 to become executive vice president of Merck .



Ajaz Hussain, Deputy Director, Office of Pharmaceutical Science, 2000 - 2005

Vice President and Global Head of Biopharmaceutical Development, Sandoz/Novartis




Peter Barton Hutt


Peter Barton Hutt   Chief Counsel-FDA  Covington & Burling  PhRMA, Nonprescription Drug Manufacturers Association



He currently advises and represents trade associations (including the Pharmaceutical Research Manufacturers of America and the Consumer Healthcare Products Association, among others) and both large and small companies in the food, drug, biologic, biotechnology, cosmetic and medical device industries. He has participated in the drafting of most major FDA legislation considered by Congress during the past 40 years.





Chief Counsel-FDA             Covington & Burling         PhRMA, Nonprescription Drug Manufacturers Association



Elizabeth Jacobson


AdvaMed News Release 05-01-03





WASHINGTON, DC – AdvaMed today announced the appointment of Elizabeth D. Jacobson as Executive Vice President, Technology & Regulatory Affairs. Jacobson, who will join AdvaMed on June 2, 2003, will head the Association’s efforts to represent the industry on all scientific, technical, regulatory and environmental issues.


“Liz Jacobson will bring to AdvaMed a wealth of scientific and public policy expertise in the area of medical technology development and regulation,” AdvaMed President Pamela G. Bailey said. “Her work as a scientist and administrator on many high profile issues during her 26 years at FDA makes her the ideal candidate to help medical technology innovators face the challenges ahead in bringing their lifesaving tests and treatments to patients. Her knowledge of the evolving science of our industry will enable AdvaMed to work pro-actively as an advocate for regulatory processes that advance global health care.”


Jacobson joined the FDA in 1975 as a research geneticist and held a number of senior science and management positions in the Center for Devices and Radiological Health (CDRH) and FDA. As Acting FDA Senior Advisor for Science (2000-2001), she was the senior science advisor to the FDA Commissioner and coordinated agency-wide activities dealing with science matters, including human subject protection and anti-bioterrorism programs. Jacobson also directed the FDA's Office of Science Coordination and Communications. Previously, as Deputy Director of CDRH (1990-2001), she developed programs to assure the safety and effectiveness of medical devices and participated in the re-engineering of the review process. As Director of CDRH’s Office of Science and Technology (1985-1990), she directed the laboratory research and testing programs in the physical, life and engineering sciences for the Center.


Jacobson is a past chair of the Global Harmonization Task Force, and currently serves as a member of Health Canada’s Science Advisory Board. She recently completed two elected terms as a member of the board of directors of the NCCLS, formerly the National Committee for Clinical Laboratory Standards, a voluntary consensus standards organization.


Jacobson holds a bachelor's degree in biological sciences from Binghamton University. She also earned a doctorate in biology from Georgetown University.


AdvaMed, the Advanced Medical Technology Association, represents more than 1,100 innovators and manufacturers of medical devices, diagnostic products and medical information systems. Our members produce nearly 90 percent of the $71 billion health care technology products consumed annually in the United States, and nearly 50 percent of $169 billion purchased around the world annually.



Ron Johnson



Abbott recently discontinued its association with Quintiles Consulting, while maintaining that it was not disappointed with Quintiles' performance. (Like Abbott, Quintiles is rich in former FDA leaders, including former CDRH compliance director Ron Johnson).




Jack W. Martin  FDA


The Players: Jack W. Martin 

 Government Employer: FDA

 Private Sector Employer:Parry and Romani Associates 

Client(s) Represented:

Abbott, American Home Products, Bristol- Myers Squibb, Glaxo-Wellcome,  Hoechst Marion Roussel, ICN Pharmaceuticals, Interneuron Pharmaceuticals, Metagenics, Monsanto,  Pfizer,  Pharmacia & Upjohn, Schering-Plough,  and SmithKline Beecham


http://www.lobbycongress.com/newpage9.htl (broken link)

Government Employer

Mr. Jack W. Martin served as Associate Commissioner for Public Affairs at the FDA. After his tenure as Associate Commissioner for Public Affairs, Mr. Martin served as Special Assistant to the Commissioner for Policy under Commissioners Frank Young and David Kessler.

Private Sector Employer

Mr. Martin is currently Vice President for Federal Relations at Parry, Romani, and DeConcini, Inc.- a Washington, D.C. based lobbying firm. In 1998, Mr. Martin was a registered lobbyist for Abbott, American Home Products, Bristol-Myers Squibb, Glaxo-Wellcome, Hoechst Marion Roussel, ICN Pharmaceuticals, Interneuron Pharmaceuticals, Metagenics, Monsanto, Pfizer, Pharmacia & Upjohn, Schering-Plough, and SmithKline Beecham.



Terry Medley .


. . former administrator of the Animal and Plant Health Inspection Service (APHIS) of the United States Department of Agriculture, former chair and vice-chair of the United States Department of Agriculture Biotechnology Council, former member of the U.S. Food and Drug Administration (FDA) food advisory committee, . . . and now Director of Regulatory and External Affairs of Dupont Corporation's Agricultural Enterprise.



Monsanto employees and government regulatory agencies

employees are the same people!

Date: Tue, 07 Dec 1999 10:43:59 -0600

From: Peter Khaled <pkhaled@earthlink.net>

Subject: Revolving Door - Updated list - FYI


David W. Beier . . .former head of Government Affairs for

Genentech, Inc., . . .now chief domestic policy advisor to Al

Gore, Vice President of the United States.


Linda J. Fisher . . .former Assistant Administrator of the

United States Environmental Protection Agency's Office of

Pollution Prevention, Pesticides, and Toxic Substances, . . .now

Vice President of Government and Public Affairs for Monsanto



Michael A. Friedman, M.D. . . former acting commissioner of

the United States Food and Drug Administration (FDA)

Department of Health and Human Services . . .now senior

vice-president for clinical affairs at G. D. Searle & Co., a

pharmaceutical division of Monsanto Corporation.


L. Val Giddings . . . former biotechnology regulator and

(biosafety) negotiator at the United States Department of

Agriculture (USDA/APHIS), . . .now Vice President for Food &

Agriculture of the Biotechnology Industry Organization (BIO).


Mark Goldberger, Director, Office of Antimicrobial Products- 2007





Marcia Hale . . . former assistant to the President of the

United States and director for intergovernmental affairs, . .

.now Director of International Government Affairs for Monsanto



Michael (Mickey) Kantor. . . former Secretary of the United

States Department of Commerce and former Trade

Representative of the United States, . . .now member of the

board of directors of Monsanto Corporation.


Josh King . . . former director of production for White House

events, . . . now director of global communication in the

Washington, D.C. office of Monsanto Corporation.


Terry Medley . . . former administrator of the Animal and

Plant Health Inspection Service (APHIS) of the United States

Department of Agriculture, former chair and vice-chair of the

United States Department of Agriculture Biotechnology Council,

former member of the U.S. Food and Drug Administration (FDA)

food advisory committee, . . . and now Director of Regulatory

and External Affairs of Dupont Corporation's Agricultural





Gerard F. Meyer


Board member Gerald F. Meyer is a senior consultant at AAC Consulting Group, which, its web site says, “provides a full range of support and compliance assistance. . . . offers a team of former high-level FDA officials and industry experts.”



Answers 05/15/1989


                                 May 15, 1989


    During recent hearings before the subcommittee on oversight of the House

Committee on Energy and Commerce, serious allegations were made regarding the

operation of the generic drug review process at FDA.  In light of the charges,

and while investigations continue, FDA has temporarily placed the generic drug

review process under the immediate supervision of Carl C. Peck, M.D., director

of FDA's Center for Drug Evaluation and Research.

    The following can be used to answer questions:

    -- The Division of Generic Drugs and the Division of Bioequivalence, the

two units that review generic drugs, were placed temporarily under Dr. Peck's

direct supervision.  He and CDER Deputy Director Gerald F. Meyer will have

authority for approving or rejecting abbreviated new drug applications (ANDAs)

for generic drugs pending FDA's review of the charges and pertinent


    -- Richard A. Terselic -- currently a deputy director in the Office of

Drug Evaluation I (which reviews original, brand-name drugs) -- has been

appointed as the acting director of the generic drugs division.  Robert

Jerussi, Ph.D., deputy director of one of the divisions in the Office of Drug

Evaluation I, will be detailed to this generic division as acting deputy

director for chemistry.  The current director of the generic drugs

division, Marvin Siefe, M.D., has been detalied to the Office of Drug

Evaluation I, where he will assist in the review of brand name drugs.

    -- Shrikant V. Dighe, Ph.D., will continue as the director of the

bioequivalence division but will report directly to Dr. Peck. The other

divisions within the Office of Drug Standards will remain in place, reporting

to Peter Rheinstein, M.D.

    "FDA management is taking action in order to be sure the generic drug

process operates fairly - and with no doubt in the public's mind about these

products - while studies of the generic drug operations continue," Acting

Deputy Commissioner James S. Benson said.

    "This will be accomplished by having the divisions of bioequivalence and

generic drugs report directly to Dr. Peck for the present -- until the charges

have been more fully examined," he said.

    During the next few weeks, the FDA will review the structural and

personnel issues in the generic drug program, with the goal of ensuring a fair

system that results in safe and effective generic drugs being provided to


    During this process, the new management will cooperate with HHS' Office of

the Inspector General, which is in the process of beginning an audit of FDA's

generic drug approval process. The IG began the audit in April at the request

of FDA Commissioner Frank E Young.

    The reorganization of the generic drug review process is not expected to

affect the review of brand-name drugs.



Harry M. Meyer, Jr., MD, Director FDA Bureau of Biologics, 1972-1987.


Thu, 22 May 2003

Bayer Documents: AIDS Tainted Blood Killed Thousands of Hemophiliacs



Until 1993, he was president of the medical research division of American Cyanamid Co. in New York, directing development of pharmaceuticals.



Robert Meyer Head of the Office of Drug Evaluation II, - 2007





Mark Novitch


Acting FDA Commissioner, Mark Novitch approved aspartame for use in carbonated beverages and carbonated beverage syrup bases (Federal Register 1983). FDA Commissioner, Arthur Hull Hayes was out of town the day that the approval was signed, but he worked closely with Mark Novitch on this issue(Gordon 1987, page 499 of US Senate 1987). Ignoring the FDA's own safety standards, he more than doubled the Acceptable Daily Intake (ADI) of aspartame from 20 mg/kg to 50 mg/kg (Metzenbaum 1985).



Mark Novitch, M.D.

Former Vice Chairman of the Board, The Upjohn Company




Alteon Inc. (ticker: ALT, exchange: American Stock Exchange) News Release - 6/5/2001








[David Orloff – FDA Division Director, 2000-2005

Still at FDA May06? See: http://directory.psc.gov/employee.htm






“Medpace is a global, full-service Contract Research Organization (CRO) providing comprehensive clinical research support to the pharmaceutical industry.”]



Stuart Pape


Stuart Pape was the Health and Human Services (HHS) Chief Counsel for Foods from October 1976 to March 1979. He served as special assistant to the FDA Commissioner from March 1979 to December 1979.

He participated in meetings and discussions on aspartame as well as representing the FDA at the PBOI.

In December 1979, Mr. Pape was given a job by the law firm of Patton, Boggs, and Blow. This law firm provided counsel to the National Soft Drink Association (NSDA). Mr. Pape and Howard R. Roberts of the NSDA (who formerly  fought for approval of aspartame at the FDA) met with the FDA twice in 1983 where aspartame was discussed. In 1983, the NSDA inexplicably withdrew their objection to aspartame in diet beverage (GAO 1986).



Between 1979 and 1982, four more FDA officials who participated in the approval process took jobs linked to the NutraSweet industry: Pape; acting FDA commissioner Sherwin Gardner; Albert Kolbye, who was

associate director of the Bureau of Foods for toxicology, and Mike Taylor, an FDA lawyer who represented the bureau before the Board of Inquiry. All four denied any conflict of interest.


 GAO Report July 1986




Week of March 27 - April 2, 1998

Non-FDA Participants

Stuart Pape, Mike Taylor, representing Hoechst Corporation Acesulfame K Petition



Mary Pendergast


Our Board of Directors

Mary K. Pendergast, JD, LLM

Ms. Pendergast has served as a director since June 2002. Most recently she served as executive vice president, Government Affairs at Elan Corporation, where she was involved in significant regulatory, strategic and government issues.

Prior to joining Elan, Ms. Pendergast was the deputy commissioner and senior advisor to the Commissioner at the U.S. Food and Drug Administration (FDA) from 1990 to 1998. There she led the agency's efforts to revise its regulation of emerging scientific areas such as biotechnology, cellular and tissue-based therapies, xenotransplantation, genetic testing and acute care research. She also served as the FDA's "crisis manager," handling sensitive, critical or precedent-setting situations and provided leadership across the agency on high priority initiatives. In addition, Ms. Pendergast has served as associate chief counsel for enforcement at the FDA from 1979 to 1990 and as attorney, Office of the General Counsel, Department of Health and Human Services from 1977 to 1979.



Company Overview

Nuvelo, Inc. is a publicly traded biopharmaceutical company dedicated to the discovery, development and commercialization of life improving therapeutics for the treatment of acute cardiovascular indications and cancer. Nuvelo’s clinical pipeline includes three product candidates: 1. alfimeprase, a direct acting thrombolytic for the treatment of acute peripheral arterial occlusion (PAO) and catheter occlusion; 2. rNAPc2, an anticoagulant that inhibits factor VIIa/tissue factor and 3. ARC183, a direct thrombin inhibitor that is being developed for use in acute anticoagulant applications.

In addition to its clinical development pipeline, Nuvelo expects to leverage its proprietary research programs and expertise in secreted proteins and antibody discovery to expand its pipeline and create partnering and licensing opportunities.



Hearing, which had two presenters.

- Eric Reiman, M.D., University of Arizona & Good Samaritan Positron Emission Tomography Ctr

- Mary Pendergast, Elan Pharmaceutical Management Corp.


Joseph X. Phillips


About the Author

Joseph X. Phillips joined ISPE in 2003 as Regulatory Affairs Advisor and was appointed to the US Food and Drug Administration (FDA) as a special government employee on the Pharmaceutical Science Advisory Committee that is involved in the agency’s new “Risk-Based Approach to Pharmaceutical Current Good Manufacturing Practices (cGMPs) for the 21st Century” initiative.  Previously, Phillips was Vice President, Pharmaceutical Services for Quintiles Consulting following a 44-year career with the FDA. At the FDA he served as Deputy Regional Director of the Agency’s Central Region. He was heavily involved in training of FDA Investigators and in planning and managing pharmaceutical programs including the Pre-Approval Inspection program and the SUPAC (Scale-Up and Post Approval Changes) for field operations. Phillips was a principal negotiator for the US/EU Mutual Recognition Agreement and was the FDA Lead to the International Conference on Harmonization (ICH) Expert Working Group for GMP Guidance for Active Pharmaceutical Ingredients (ICH Q7A Guidance)


Wayne Pines


In Reply to Editorial Comment from: Wayne L. Pines Re: Congressional Hearings on Vaccines and Autism




Wayne Pines, president, regulatory services and health care, APCO Worldwide, provides strategic counsel to clients facing crises or media, legislative, regulatory or marketing problems. He has worked on health care reform, litigation, tampering, product approvals, advertising issues, recalls, environmental problems and Congressional and Food and Drug Administration (FDA) hearings.


Mr. Pines is a member of board of the Medstar Research Institute, Scolr Pharma Inc., The Patient Channel, and the Food and Drug Administration Alumni Association. He was a member of the Public Health Service’s first Task Force on AIDS Education. He is listed in Who’s Who in America.


Before joining APCO in 1993, Mr. Pines was executive vice president of a large international public relations agency. For the 10 years prior to that, Mr. Pines served at the FDA as chief of consumer education and information, chief of press relations and associate commissioner for public affairs. He was the chief spokesman of FDA for seven years and also was the founding editor of FDA consumer magazine. In 2004, Mr. Pines was named FDA’s Alumnus of the Year.


Mr. Pines is the author or editor of several books, including When Lightning Strikes: A How-To Crisis Manual With Classic Case Studies; The FDA Advertising and Promotion Manual; A Practical Guide to Food and Drug Law and Regulation; A Framework for Pharmaceutical Risk Management, and Crisis Communications in Healthcare: A Delicate Balance. He co-authored an article in the Journal of the American Medical Association (November 1990) with FDA Commissioner David A. Kessler on FDA regulation of drug advertising and promotion. From 1985 to 1990, Mr. Pines wrote a monthly column for Medical Advertising News. He has been published widely on regulatory and crisis management topics.


Mr. Pines started his career as reporter and then city editor of a daily newspaper in Middletown, New York, desk editor with Reuters News Service in London, and associate editor of The Pink Sheet, a pharmaceutical trade publication. He has taught graduate courses in public relations and frequently speaks at educational symposia. He has chaired the annual advertising meetings for both the Drug Information Association and the Food and Drug Law Institute since 1989, and has been given each organization’s highest award. Mr. Pines holds a bachelor’s degree from Rutgers University.


Peter Pitts- FDA Associate Commissioner for External Relations.

SVP-Global Health Affairs for Manning, Selvage & Lee



Howard Roberts


Howard Roberts, acting director of FDA’s Bureau of Foods, appointed a five-person task force to review the Bressler team’s findings pending a decision on whether to throw out the three tumor and birth-defect

studies…In October, 1978, a year after ordering the review that helped get Searle’s petition back on track, Roberts (acting Director of Bureau of Foods) quit to become vice president at the National Soft Drink

Association. The NSDA’s members later marketed a stream of NutraSweet-flavored diet soft drink products.

Reached at NSDA, Roberts dismissed Verrett’s criticism, asserting the task force report "really was of no importance." He said he had no concerns about the appearance of his taking the NSDA job, stressing

He does not represent NSDA before the FDA. "I sleep well at night," he said.


 GAO Report July 1986


Amit Sachdev

Amit Sachdev, Executive Vice President, Health, Biotechnology Industry Organization (BIO) and Former FDA Deputy Commissioner for Policy;




Gail Sherman

PDA Parenteral Drug Association


September 11-15, 2006


The Foundation for Business Success: Continuous Improvement Throughout the Product Life Cycle


What will it take to change the performance of the pharmaceutical and biopharmaceutical industries from acceptable to exceptional? Industry executives, academics and authors will come together with FDA representatives at the 2006 PDA/FDA Joint Regulatory Conference to discuss what steps need to be taken to improve the performance of the industry. The conference brings the pharmaceutical and biopharmaceutical experts to you! Don’t miss this invaluable opportunity to hear from FDA representatives as they outline their expectations for current and emerging regulatory guidelines as well as the implications of these guidelines to development, manufacturing, quality and regulation.


Take-Home Benefits


Academics, authors and executives will discuss moving the industry from acceptable to exceptional performance through continuous improvement


FDA will discuss expectations for current and emerging regulatory guidelines and their implications to development, manufacturing, quality and regulatory


Industry and non-industry cases studies will highlight continuous product and process improvement concepts


Who Should Attend



Research & Development


Regulatory Affairs




Quality Control/Assurance






Job Functions


Supply Chain




Executive Management




Event Home Page:  http://www.pda.org/pdafda2006

Special Notice:  *Health Authority, Academic, and Student Registrants please fax or mail your registration

Location: Washington, D.C. - Renaissance Hotel

Contact: Conferences - Wanda Neal (neal@pda.org) / Exhibits - Nahid Kiani (kiani@pda.org) / Training - Gail Sherman (sherman@pda.org)


Senior Manager CBER


PDA Global Headquarters

3 Bethesda Metro Center, Suite 1500

Bethesda, MD 20814

Tel: +1 (301) 656-5900

Fax: +1 (301) 986-0296


August 12, 2004

Contact: Walter Morris


Tel: +1 (301) 656-5900, ext. 148

Former U.S. FDA Sr. Manager Gail H. Sherman Takes Helm of PDA Training and Research Institute


Bethesda, Md. (August 12, 2004): PDA welcomes Gail H. Sherman as the association’s new Vice President of Education and Director of the PDA Training and Research Institute.

Ms. Sherman brings to PDA over 20 years of professional training experience with the U.S. Department of Health and Human Services, the last 13 years of which came with the U.S. FDA Center for Biologics and Research (CBER). As a senior manager with CBER, Ms. Sherman led teams of scientific, public affairs and education specialists to develop curriculums and standard operating procedures on a variety of challenging scientific and technical subjects.

“PDA is extremely excited to have on board an executive with substantial experience as a professional trainer,” said PDA President Neal Koller. “Having worked for the U.S. FDA, Gail has a unique perspective of the important technical and regulatory issues facing pharmaceutical and biopharmaceutical manufacturers today. She is certain to strengthen all of PDA’s Career-long Learning initiatives and educational offerings.”

During the last seven years, Ms. Sherman served as the Director of CBER’s Division of Manufacturers Assistance and Training, where she was responsible for managing both internal training programs and external outreach to industry. Ms. Sherman was instrumental in developing a reviewer training program for CBER’s regulatory, compliance and research staff. This successful lecture and interactive course integrated regulatory processes with specific scientific issues. Ms. Sherman later delivered the program to biopharmaceutical manufacturers as a workshop called CBER 101 for the Industry, which has been held in March of 2003 and 2004 near CBER’s headquarters in Maryland. Other responsibilities included the management of CBER’s speaker program and oversight over CBER liaison meetings with industry organizations.

Ms. Sherman is actively involved with a number of pharmaceutical and biopharmaceutical professional associations and has provided leadership on several industry and FDA committees. She has worked closely with PDA over the years and is a member of the Drug Information Association. Ms. Sherman helped develop several PDA conferences, including the 2002 and 2004 PDA Training Conferences, the 2000 PDA/FDA Team Biologics Update Workshop, and the 1999 PDA/FDA Joint Regulatory Conference.


Jeffrey Springer


Welcome To AAC Consulting Group


You probably know that AAC has been providing consulting, auditing, training support and assistance to the industries regulated by the FDA and similar agencies since 1960. We’re staffed with a uniquely qualified team of former high level FDA officials and industry experts.


But did you know that AAC is now part of Kendle, a leading global clinical research organization?


Together, Kendle/AAC takes care of all your regulatory needs. From study design to manufacturing and distribution of FDA regulated products, we can help you navigate the maze of regulatory requirements.


  We’re committed to your total satisfaction


Jeffrey B. Springer


Senior Consultant and Special Counsel to the President


 Jeffrey Springer offers your company 33 years of experience as an attorney in the Office of the Chief Counsel of the FDA.  He provides clients like you with a wide range of regulatory consulting services.  He is especially forthcoming with advice and assistance on compliance matters and strategy.  With his background managing legal reviews and litigation, and clearing the FDA’s regulations, Mr. Springer would be a valuable asset to your project team. 


Mr. Springer received his law degree in 1968 from the Georgetown University Law Center.  He immediately became a trial attorney for the FDA, representing the agency in civil and criminal enforcement cases in court.  He also represented the FDA in defensive and appellate litigation in court.  From this position, he became the Special Assistant to the Chief Counsel, where he assisted with law office management, resolving problems with staff employees and being responsible for special projects.  In 1975 he became the Deputy for Regulations and Hearings.  This position required him to manage the legal review and clearance of agency regulations, the program review services, and administrative hearings.  He became the Deputy Chief Counsel in 1979, a position he held for 20 years, assisting the Chief Counsel with internal management, providing legal service and advice to high-ranking FDA officials, representing the FDA in functions involving other federal agencies, and improving the process of reviewing proposed legal and regulatory actions.  His final role at the FDA was as a Senior Advisor to the Chief Counsel.  He provided consultant advice, assistance, and services concerning operations and management, was responsible for the law office redesign and reorganization, and managed the attorney recruitment and selection program.  Mr. Springer received numerous awards in his time with the FDA, such as the Commissioner’s Special Citation in 1989 and 1999.  He is also a member of the District of Columbia Bar Association.



Mr. Springer joined AAC in 2002 as a Senior Consultant and Special Counsel to the President.  As of 2005 he has functioned as a contractor and is still available to assist AAC clients. His first-hand knowledge of regulations and regulatory actions will give your company the upper hand in dealing with FDA inspections and audits.  You owe it to your company to tap this resource


Tel: 301-838-3120

Fax: 301-838-3182

Email: jspringer@aacgroup.com


Linda Suydam


USA Today

USA Exposes FDA Conflicts

... "The best experts for the FDA are often the best experts to consult with industry,"

says FDA senior associate commissioner Linda Suydam, who is in charge of waiving conflict-of-interest restrictions.



Congressional report slams FDA, CDC policies on disclosure

... The FDA's senior associate commissioner Linda Suydam told Reuters Health, ``We feel pretty strong that we have a system in place that protects from conflict of interest from the advisory committee members.''...



…How does the FDA get away with a behavior that the Ralph Nader-founded Public Citizen’s Health Research Group calls “outrageous”? They accomplish this modern highway robbery through the generous practice of granting “waivers.” The FDA is permitted to waive the conflict of interest rules if an expert’s value outweighs the potential financial conflict. This sounds reasonable until you learn that 803 waivers were granted over a two-year period starting in 1998. In fact, the report determined that there were financial conflicts in 146 of 159 FDA advisory meetings during this time…



Optimizing OTC market potential - View from the Top'03: CHPA - Consumer Healthcare Products Association's priorities for 2003

Drug Store News,  Jan 20, 2003  by Michael Johnsen

 Linda Suydam, president of the Consumer Healthcare Products Association, was bullish on sales of over-the-counter products for 2003, predicting a high single-digit sales growth that would bring more than $1 billion in incremental sales to retail tills this year.

Suydam is bullish for good reason--self care has emerged as a strong consumer current within the health care industry. According to a Roper Starch Worldwide study commissioned by CHPA and released last year, 75 percent of Americans prefer self diagnosis and treatment rather than a doctor visit.

Besides, 2003 may very well be book-ended by a pair of blockbuster Rx-to-OTC switches. Loratadine switched last month, creating an instant market for nondrowsy allergy relief with Claritin (Schering-Plough) and Alavert (Wyeth). Heartburn reliever Prilosec, to be marketed by Procter & Gamble, is projected to switch this fall upon P&G's completion of label-use studies.

However, predicting switch success can be a dicey proposition, Suydam cautioned. "Everybody thought the H2 [switch] products would be terrific [sellers], and they weren't good as people [predicted]," she said

Of course, there's plenty of OTC market potential out there outside of switch prospects that the trade can realize in 2003, Suydam suggested. "There are a lot of people who could benefit from OTC medicines and just don't know enough about them," she explained, for instance, getting "every person who could benefit from taking an aspirin every day" on such a regimen. Which is why CHPA will be researching strategies on how to optimize OTC utilization over the next year, she added.

Suydam identified three other major priorities for the OTC industry in 2003.

First, CHPA wants to improve the Rx-to-OTC switch climate, better enabling manufacturers to bring proven safe and effective medicines into the OTC arena, for example, by driving comprehensive consumer education, advocating a more predictable and transparent process and building a better working relationship with the Food and Drug Administration.

CHPA also is exploring ways in which the organization can help expedite the current monograph process. Currently, 23 OTC ingredients still are marketed under tentative monographs. CHPA hopes to assist the FDA in moving that process along with the least impact on OTC product manufacturers.

Another priority for CHPA in 2003 lies in identifying OTC risk management issues. "That's playing out in a variety of ways, with the FDA's new good manufacturing practices initiative and also on the switch side in terms of how [manufacturers] get messages across [to the consumer] about product safety," Suydam noted.

For that reason, CHPA has made consumer education a key focus in 2003. While consumer education always has been a priority for the organization, CHPA is hoping to take its current programs to new levels through strategic alliances with other healthcare-related organizations, including the Women's Health Resource Center and the FDA. "We are always looking for opportunities to partner with organizations [to] better utilize our resources and supplement whatever resources [they may] have, as well," she said. Suydam points to the OTC industry's success in helping to draft new regulations for OTC drug facts labeling. "That's a step in the right direction," she said.

Of course, education also extends into making sure that consumers understand the OTC value proposition--another important opportunity to grow the business. "Consumers are always looking for value. If we can make sure they understand what a great value they get from safe, effective and easily accessible [OTC] products," OTC utilization will grow, she added.


Mike Taylor


Between 1979 and 1982, four more FDA officials who participated in the approval process took jobs linked to the NutraSweet industry: Pape; acting FDA commissioner Sherwin Gardner; Albert Kolbye, who was

associate director of the Bureau of Foods for toxicology, and Mike Taylor, an FDA lawyer who represented the bureau before the Board of Inquiry. All four denied any conflict of interest.



Michael Taylor . . . former legal advisor to the United States Food and Drug Administration (FDA)'s Bureau of Medical Devices and Bureau of Foods, later executive assistant to the Commissioner of the FDA, . . . still later a partner at the law firm of King & Spaulding where he supervised a nine-lawyer group whose clients included Monsanto Agricultural Company, . . . still later Deputy Commissioner for Policy at the United States Food and Drug Administration, . . . and later with the law firm of King & Spaulding. . . . now head of the Washington, D.C. office of Monsanto Corporation.*



 The Monsanto Files

The FDA's pro-rBGH activities make more sense in light of conflicts of interest between the FDA and the Monsanto corporation." Michael R. Taylor, the FDA's deputy commissioner for policy, wrote the FDA's rBGH labelling guidelines. The guidelines, announced in February 1994, virtually prohibited dairy corporations from making any real distinction between products produced with and without rBGH." To keep rBGH-milk from being "stigmatized" in the marketplace, the FDA announced that labels on non-rBGH products must state that there is no difference between rBGH and the naturally occurring hormone. In March 1994, Taylor was publicly exposed as a former lawyer for the Monsanto corporation for seven years. While working for Monsanto, Taylor had prepared a memo for the company as to whether or not it would be constitutional for states to erect labelling laws concerning rBGH dairy products. In other words. Taylor helped Monsanto figure out whether or not the corporation could sue states or companies that wanted to tell the public that their products were free of Monsanto's drug.



And as though the FDA didn't already exhibit enough audacity it handed Michael Taylor the responsibility to make the decision as to whether or not rBGH-derived milk should be labeled. (At the time, Michael Taylor, who had previously worked as a lawyer for Monsanto, was executive assistant to the Commissioner of the FDA.) In 1994, Taylor ended up writing the rBGH labeling guidelines that prohibit the dairy industry from stating that their products either contain or are free from rBGH. Even worse, to keep rBGH-milk from being "stigmatized" in the marketplace, the FDA ruled that the labels of non-rBGH products must state that there is no difference between rBGH and the natural hormone.8 According to journalist Jennifer Ferraro, "while working for Monsanto,Taylor had prepared a memo for the company as to whether or not it would be constitutional for states to erect labeling laws concerning rBGH dairy products. In other words, Taylor helped Monsanto figure out whether or not the corporation could sue states or companies that wanted to tell the public that their products were free of Monsanto's drug."9

 The current situation

Monsanto is suing Maine-based Oakhurst Dairy for labeling their milk "Our Farmers' Pledge: No Artificial Growth Hormones." According to Monsanto, Oakhurst Dairy does not have the right to let its customers know whether its milk contains genetically engineered hormones.




Week of March 27 - April 2, 1998

Non-FDA Participants

Stuart Pape, Mike Taylor, representing Hoechst Corporation Acesulfame K Petition



Michael Taylor Named Director of RFF’s Center for Risk Management


(Washington, D.C., June 1, 2000) - Michael R. Taylor is the new director of Resources for the Future’s (RFF) Center for Risk Management, and will serve as a senior fellow, RFF President Paul Portney announced today. Taylor, a lawyer who has held senior policy positions at the U.S. Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA), and was a vice president at Monsanto Company, succeeds J. Clarence (Terry) Davies, who retired earlier this month. Taylor will begin June 1.


"Mike’ extensive experience in public health regulation and with all aspects of the policy process — as both a practitioner and scholar — will make him a tremendous asset to RFF," Portney said.


In addition to guiding the Center’s future activities, Taylor will develop a research program on policy and institutional issues that affect the success of the global food and agricultural system in such areas as food security, food safety and nutrition, environmental protection, and conservation of natural resources.


Analysts at the Center for Risk Management carry out a multi-disciplinary program of research, policy analysis, and outreach related to human health and the environment. Ongoing projects at the Center include a Congressionally requested examination of the likely future costs of Superfund, a study of how the Internet may affect public participation in environmental policy in the future, and a project evaluating how to better involve communities in the rehabilitation of abandoned or heavily polluted sites. Recently completed projects include a study of the environmental impacts of the service sector, and an analysis of the use of science at the Environmental Protection Agency.


"I am delighted to be joining RFF, especially now, when its rigorous research and objective analytical work are needed more than ever to address pressing public issues," Taylor said.


Prior to coming to RFF, Taylor was Vice President for Public Policy at Monsanto and a partner in the Washington, D.C. law firm King & Spalding. In addition, he served as Administrator of the USDA Food Safety and Inspection Service from 1994 to 1996, as FDA Deputy Commissioner for Policy from 1991 to 1994, and as Executive Assistant to the FDA Commissioner in 1980. He is an adjunct professor of law at Georgetown University Law Center, and received his law degree from the University of Virginia.


Michael Taylor, RFF Senior Fellow and Division Director, (202) 328-5066, taylor@rff.org.

Jonathan Halperin, Director, Communications Planning & Strategy,

(202) 328-5030, halperin@rff.org.



Michael Taylor, Washington lawyer at King and Spaulding, a premier D.C. law firm representing corporate clients including Monsanto, becoming associate FDA commissioner for policy. After Taylor rejoined his old law firm, Monsanto hired him to direct its corporate strategy in Washington. He then became an Under-Secretary at the United States Department of Agriculture (USDA), One week after Clinton gained re-election, Taylor resigned from USDA and is now back at King and Spalding



Mark Thorton – Medical Officer, Oncology Products


Mark O. Thornton, M.D., M.P.H., Ph.D. serves as Senior Vice President of Product Development. Dr. Thornton, a Clinical Pharmacologist and Trialist, has divided his 15-year career at FDA and in the biotechnology industry equally between oncology and infectious disease biologics clinical development.  At the FDA, he was on the clinical review team for Erbitux(R) for its initial colon cancer indication, and Pegasys(R) for its Hepatitis C indication. At the FDA he also led the initial efforts to establish the FDA Gene Therapy Patient Tracking System and published on the topic of optimizing regulatory pathways for cancer vaccines.  In industry, Dr. Thornton has performed Phase I-III clinical trials in both oncology and infectious disease settings, and successfully submitted PLAs for Certiva(TM) while at North American Vaccine and WinRho(R) while at Univax Biologics.


ThortonMark- MedicalOfficer, Office of OncologyProducts, 2001-2004

Chief Medical Officer, ZioPharm, 2004-2005

Managing Director, Angiotech Pharmaceuticals, 2005-2006

Senior Vice-President, ClinicalDevelopment, Genvec 2006




Daniel Troy - FDA Chief Counsel, 2001-2004

Sidley Austin , Partner, 2004






John C. Villforth



John C. Villforth, President, The Food and Drug Law Institute (Washington, DC)



Villforth is on the board of directors of Vasogen, which makes heart drugs, and EduNeering, which provides regulatory compliance “learning solutions.” He has also been on the boards of other medical companies.




Board of Directors

Rear Admiral Villforth is past-President and Executive Director of The Food and Drug Law Institute, a non-profit organization whose mission is to increase knowledge about the laws and regulations pertaining to foods, drugs, cosmetics, medical devices, and biological products. He was a Commissioned Officer in the U.S. Public Health Service in the Department of Health and Human Services for 29 years, the last 19 years of which he was assigned to the Food and Drug Administration (FDA) where he served as Director, Center for Devices and Radiological Health. He retired from the Public Health Service in 1990 with the rank of Assistant Surgeon General (Rear Admiral). In 2002, he was appointed Chairman of the Board of the FDA Alumni Association. Rear Admiral Villforth has served on the boards of MiniMed Inc., a world leader in diabetes management systems, Target Therapeutics Inc., a medical device company subsequently acquired by Boston Scientific Corp., and BRI International, a contract research organization for the biotechnology, pharmaceutical, and medical devices industries, subsequently acquired by Quintiles Transnational Corp. He currently serves on the board of EduNeering Inc. Rear Admiral Villforth joined Vasogen’s Board in 2001.



William Vodra

FDA AssociateChiefCounselForDrugs, 1974 – 1979





Arnold and Porter LLP

William W. Vodra


Washington, DC Office


202.942.5999 fax



Areas of Expertise:

   Food, Drug and Medical Devices 

   Life Sciences 

   Biotech and Medical Technology 

   Product Liability and Mass Tort Litigation 


Bill Vodra specializes in regulatory issues involving the safety, effectiveness, and marketing of medical products and in crisis management. He has led teams defending embattled products and has successfully represented clients in white-collar criminal matters as well as a range of civil actions. Notable matters in which Bill was involved include:


Embattled products: Feldene (piroxicam) (1986-88); Versed (1987-89); Bjork-Shiley Heart Valve (1989-1994).

FDA consent decrees: American Red Cross (1993); Abbott Laboratories (1999); Wyeth Laboratories (2000).

Product liability: Feldene (1986-88); Bjork-Shiley Heart Valve (1989-94); diet drugs (“fen-phen”) (1997-99).

Unfair competition litigation: the “Aspirin-Tylenol wars” (1979-87); Zyrtec-Claritin (1996-2001)

Legal Times named Bill Vodra as a Leading Lawyer in Food and Drug Law in September 2005. He is also rated in the first tier of Life Sciences: Regulatory lawyers by Practical Law Company Global Counsel (2003-05) and of Healthcare Lawyers by Chambers USA (2003-05).


Prior to joining Arnold & Porter, Bill served as the Associate Chief Counsel for Drugs for FDA, and as Assistant Chief Counsel for DEA. He drafted many agency regulations still in use, including those implementing the Controlled Substances Act and FDA’s rules for Good Manufacturing Practices, Good Laboratory Practices, Good Clinical Practices, bioequivalency and the Orange Book.


Frank Young


"The Pharmaceutical Advertising Council (PAC) and the United States Food and Drug Administration have just announced a unique program...to warn the public about the dangers of quack medical products..." 

-From an October 22, 1984 letter signed jointly by Frank Young, FDA Commissioner and Roger O'Neill, president of PAC, on PAC/FDA letterhead 

"...attached is a list of companies...who have donated money to the PAC/FDA anti-quackery program..."

Beecham Laboratories Merck Sharpe and Dohme 

Bristol Meyers Company Organon, Inc. 

Burroughs Wellcome Co. Pennwalt Co. 

Carter Wallace Inc. 

The Proprietary Association A.H. Robbins 

Hoechst-Roussel Pharmaceuticals 

Hoffman-LaRoche Inc. 

Rover Group Janssen Pharmaceutical 

Sandoz Jeffrey Martin Inc. 

Schering Corp. Johnson & Johnson 

Squibb Knoll Pharmaceutical 

Sterling Drug, Inc. Lederle Laboratories 

Stuart Pharmaceuticals McNeil Company 

Syntex Corporation Warner Lambert Company 

-from a November 15, 1985 letter on PAC/FDA letterhead signed by John Chusid, coordinator, PAC/FDA anti-quackery program



The FDA's generic drug scandal hit the news in 1989. Some companies were obtaining fast approvals for their drugs from the FDA while others were delayed for years. The CEO of one company hired a private detective to investigate why some companies received approvals and his was not. They found that several FDA reviewers were accepting bribes from some drug companies to speed their drugs through the process and derail those submitted by competing companies. Eventually 42 persons and ten companies were found guilty of criminal acts.



…The negative consequences of the scandal were striking. One of the first major casualties was Commissioner Frank Young, who resigned shortly after the scandal became public. A Sept. 1992 HHS Office of Inspector General states that of July 1992, 29 individuals, including 5 FDA employees and 8 generic drug companies had pled guilty or been found guilt of fraud and deception.



Frank E. Young, Former FDA Commissioner, and Bertram A. Spilker, Senior Vice President, PhRMA,

Join LearnWright Advisory Board

Rockville, MD- LearnWright announced today that Frank Young and Bert Spilker will join its Advisory Board. LearnWright develops web-based training programs to help large pharmaceutical companies keep their employees informed and in compliance with the latest regulations. LearnWright created the Advisory Board to ensure that its products are scientifically rigorous and educationally effective.



January 3, 2002

Panacea names former FDA commissioner to board

Panacea Pharmaceuticals has appointed former Food and Drug Administration Commissioner Frank Young to its board of directors, the Rockville, Md.-based drug maker recently announced.

Young, a former assistant Surgeon General, served as FDA commissioner from 1984 to 1989. During his term, he oversaw passage of the Drug Price Competition and Patent Term Restoration Act, the Prescription Drug Marketing Act and the approval of the first AIDs-fighting drug commonly known as AZT.

More recently, Young served as director of the Office of Emergency Preparedness and the National Disaster Medical System from 1993 to 1996.

"Frank joins our board as a visionary, an expert in regulatory matters, an authority on the ethical consequences of medical research and a long time biotechnology advocate," says Hossein Ghanbari, Panacea's chairman president and CEO.


Young already serves as a director on five other corporate boards.