Food and Drug Administration

About

The FDA is America's health regulator. 'It is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.'

People

Robert Langer, who sit on the Board of Directors for Wyeth pharmaceutical company, is reported to have previously served as a member of the United States Food and Drug Administration's (FDA) SCIENCE Board (the FDA's highest advisory board). He served on the FDA's Board from 1995-2002 and was its Chairman from 1999-2002. Langer is also Institute Professor for the Massachusetts Institute of Technology and was elected to the Institute of Medicine of the National Academy of Sciences (in 1989) and in 1992 to both the National Academy of Engineering and to the National Academy of Sciences. Langer's biography states that 'he has served at various times on 15 boards of directors and 30 Scientific Advisory Boards' but only names Alkermes, Mitsubishi Pharmaceuticals, Warner-Lambert and Momenta Pharmaceuticals. He has also written over 860 articles in the medical and scientific fields and has over 500 issued or pending patents worldwide. Forbes and Bio World are reported to have named Langer as 'one of the 25 most important individuals in biotechnology in the world'.

• Sharon L Cohen - Cohen who in 2008 is listed as working for PR and lobbying firm the Podesta Group is described as having 'excellent relationships with House and Senate Leadership offices, Senate Finance and HELP committees, House Ways and Means and Energy and Commerce committees as well as with officials at the Food and Drug Administration and in the Centers for Medicare and Medicaid Services'. Cohen's biography descibes her as 'one of the most experienced and well-connected health care and biotech lobbyists in Washington'. Her previous involvements include serving as Vice President for Government Relations with the Biotechnology Industry Organization (BIO), chief lobbyist for the Health Insurance Association of America, Director of Congressional Relations for the Blue Cross Blue Shield Association, working at the American Council of Life Insurers, serving as Deputy Director of Federal Relations for the American Psychiatric Association and as Director of Health Policy for the Alliance for Aging Research.

Controversy

Sanofi-Aventis - Fraudulent 'Study 3014' and the drug 'Ketek'

In 2006, the U.S. Senate Committee on Finance (Committee) contacted the Food and Drug Administration (FDA) regarding concerns over the Sanofi-Aventis drug Ketek.

A pivitol study commissioned by Sanofi-Aventis (known as 'Study 3014') which has been used, and continues to be used, as evidence of the safety of the drug was found to be 'marred by fraud' in late 2003/early 2004. One of the investigators involved in the study lost his medical license and another investigator (Anne Campbell) was indicted for falsifying study data. She pleaded guilty in October 2003 and in 2004 was sentenced to 57 months in jail.

Yet the fraudulent nature of the Study was not disclosed to the Anti-Effective Drugs Advisory Committee (AIDAC) who were responsible for approving the drug for use by adults in 2004. It was found that Ketek can cause serious liver damage and failure and there has been many recorded instances of the death of patients through the use of this drug.

In 2006, it is reported that Sanofi-Aventis are conducting trials to test Ketek as a treatment for ear infections and tonsillitis in nearly 4,000 infants and children in more than a dozen countries. Sanofi-Aventis has three ongoing trials in children as young as 6 months old and a fourth trial involving adolescents 13 years of age and older. The Committee voices concern that the parents of these children are unlikley to know of the risks their children are being exposed to and have called on the FDA to 'consider forcing Sanofi-Aventis to withdraw Ketek from the market, severely restrict its uses, even in adults, or add a prominent warning to its label about potentially fatal side effects’.

The Committee also voice concern at the ‘FDA’s complicity with the drug maker and subsequent failure to ensure the integrity of a pivotal study about the benefits and risks of this drug’.

“The allegations of misconduct in this case are as bad as I’ve heard yet,” Grassley (the investigating officer) said. “It looks like the FDA caught the drug company red handed and let them get away with it. On top of that, the FDA failed to set the record straight and, in fact, continues to cite a discredited safety study as a principal reason to feel okay about using this drug.”

See Sanofi-Aventis Group - Fraudulent Activities for further details.