FDA: Survey Blasts Drug Approval Process

      A new Public Citizen's Health Research Group survey of doctors who review drugs for the Food and Drug Administration says new drugs are being pushed to the market too quickly. The New York Times reports that already, the survey "has drawn a scathing rebuttal from the drug industry, an oblique defense from the agency and criticism from representatives of chronically ill people who advocate swifter drug approval." The Ralph Nader-founded watchdog group compiled survey responses from 53 of the FDA's 172 medical reviewers (Grady, 12/3). According to those responses, medical reviewers felt that since 1995, the FDA approved 27 drugs it should not have (in 1996 and 1997 a record 92 drugs were approved.) Moreover, 19 respondents said they felt "somewhat greater" or "much greater" pressure to approve more drugs, and 17 said FDA standards are now "lower" or "much lower" than they used to be (Rubin, USA Today, 12/3). Eight respondents reported 14 incidents in the last three years "in which they were instructed not to present their opinion or data to an FDA advisory panel reviewing the drug," the Newark Star-Ledger reports (Silverman, 12/3). Public Citizen notes that diet drug Redux, the painkiller Duract and the blood pressure drug Posicor have all been pulled from the market after safety concerns emerged following approval (Reuters/FOX News, 12/3). "All three drugs, however, had data available before approval that raised safety concerns" (CNN, 12/3).

Pointing Fingers
      "Our findings are shocking by any yardstick," said Dr. Sidney Wolfe, director of Public Citizen's Health Research Group. "Subtle and not-so-subtle pressure is being brought to bear on FDA physicians who dare to question a drug's safety. Sometimes their safety objections are simply ignored or overruled" (PCRG release, 12/2). The Star-Ledger reports that "Wolfe called for a government investigation into FDA review procedures; a rollback of portions of recently enacted legislation that led to faster drug approvals; and more post-marketing, or follow-up, safety studies of newly approved drugs" (12/3). Jeff Trewhitt, a spokesperson for the Pharmaceutical Research and Manufacturers of America, said, "It is highly irresponsible to issue a so-called study based on clandestine communications with faceless, anonymous sources." Dr. Kenneth Kaitin the Tufts University Center for the Study of Drug Development said, "The research is shoddy, the survey is inconclusive and equivocal, and by no stretch does it support the conclusions." In a statement, Janet Woodcock, the FDA's director for the Center for Drug Evaluation and Research, said, "The public should rest assured that the FDA maintains the highest standards in the world for approving drugs" (Times, 12/3). The General Accounting Office is slated to release a report soon on the FDA's post-marketing studies of side effects (Star-Ledger, 12/3).