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FDA Approving Fewer New Drugs in Wake of Vioxx, Avandia, Other Scandals

Aug 23, 2007 | Parker Waichman Alonso, LLP

The Food & Drug Administration (FDA) is still struggling to regain credibility after its approval process came under fire as a result of scandals surrounding drugs like Vioxx, Avandia and Ketek.  That could be one reason why the FDA is approving new medications at a much slower rate than in the past.  Since January, the FDA has approved only 38 new drugs.   During the same period in 2006, the FDA had already approved 55 new medications.  

In the past several years, the FDA’s drug approval process has been criticized for allowing defective drugs to go on the market even when serious questions were raised about their safety.  Ketek is a prime example of the FDA’s lax approval process.   Ketek, an antibiotic used to treat sinus infections, was granted FDA approval in 2004, even though the FDA had found serious irregularities in clinical trials conducted by its manufacturer, Sanofi-Aventis.   At least one doctor involved in the trial falsified data and was sent to prison for fraud.  Still, Ketek was approved by the FDA in 2004.  Shortly after it approved Ketek, the FDA began receiving reports that linked it to liver problems.  The FDA eventually confirmed 53 cases of liver failure in patients using the antibiotic, including five deaths.  This past February, the FDA finally added black box warnings to the Ketek label and severely restricted its use.

Vioxx, another FDA approved drug, has been linked to severe heart problems.  In 2004, an FDA study estimated that this defective drug could have contributed to 27,785 heart attacks and sudden cardiac deaths between 1999 and 2003.  After Vioxx was pulled from the market in 2004, it was revealed that the FDA had tried to silence the drug expert who headed that study.  Dr. David Graham, associate director for science in the FDA Drug Center's Office of Drug Safety, told Senate investigators that he had been subjected to veiled threats and intimidation when he informed the FDA of his findings.

Avandia is another drug that has caused the FDA a great deal of embarrassment.  In May, a study by the Cleveland Clinic found that the diabetes drug increased a patient’s risk of heart attack by 43-percent.  In June, a congressional committee convened hearings to investigate problems with the drug.  The committee heard testimony from Dr. John Buse, a diabetes expert who raised questions about Avandia’s cardiac risks in 1999.  Dr. Buse told the committee that he felt pressured by the drug’s maker, SmithKlineBeecham (now part of GlaxoSmithKline) to sign a clarifying statement drafted by the company that downplayed his concerns.  Testimony at that hearing also revealed that the manufacturer and the FDA had known about Avandia’s heart attack risk as far back as September 2005.  However, the agency felt that more investigation was needed before conclusions could be made about Avandia’s possible safety issues.

All of these scandals have damaged the public’s confidence in the FDA’s ability to insure drug safety.  The fact that the FDA has approved fewer new medications this year could be a sign that the agency is finally starting to take that seriously.