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FDA Medical Officers Report Falling Standards Permit Dangerous Drug Approvals

Dec. 2, 1998

FDA Medical Officers Report Falling Standards
Permit Dangerous Drug Approvals

Heavy Pressure from Industry and FDA Hierarchy Cited

    WASHINGTON, D.C. — Many Food and Drug Administration (FDA) medical officers say the safety and efficacy standards for approving new drugs have been lowered in the past few years, allowing many drugs to be approved which should not have been, according to a Public Citizen?s Health Research Group study released today.

    The study, FDA Medical Officers Report Lower Standards Permit Dangerous Drug Approvals, surveyed FDA medical officers — physicians responsible for the primary reviews of New Drug Applications for drugs — to determine their opinions about recent changes in the drug approval process.

    “Our findings are shocking by any yardstick,” said Dr. Sidney M. Wolfe, Director of Public Citizen?s Health Research Group and co-author of the study. “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.”

    Nineteen medical officers identified 27 new drugs that they reviewed in the past three years and thought should not be approved but were approved anyway, and 17 medical officers described the current standards of FDA review for safety and efficacy as “lower” or “much lower” compared to those in existence prior to 1995.

    The study, conducted in September and October 1998, followed the setting of two all-time FDA records. First, the largest number of new drugs was approved in any two-year period (92 in 1996 and 1997). Second, a record three new prescription drugs (all among the record-setting 92) were banned in a 12-month period because they were too dangerous to be allowed to stay on the market. For all three — dexfenfluramine (Redux), mibefradil (Posicor) and bromfenac (Duract) — data available prior to approval raised significant safety concerns and the drugs did not represent any significant advances over drugs already on the market.

    In the study released today, eight medical officers reported 14 instances in the past three years in which they had been instructed, usually by the Office Director, not to present their own opinion or data to an FDA Advisory Committee when to do so might have reduced the likelihood that a drug would be approved.

    “These findings from FDA?s own reviewing physicians provide an alarming insight into the recent change in culture at the FDA, a change seriously jeopardizing the health of American patients by allowing drugs which would likely have been rejected in the past to get approved despite doubts about their safety or effectiveness,” said Dr. Peter Lurie, co-author of the report.

    The study quotes the disturbing words of one medical officer who said: “In the last two years, I recommended that two drugs not be approved. They were both approved without consulting me. This never happened before. In one case, the drug did not meet the standards set up by the division, so they nullified the standards.”

    In another case, a medical officer wrote that a high-ranking FDA official had said, “Everything is approvable. We can use the label creatively to lower the problems.”

    The study also found that:

  • Twelve medical officers identified 25 different new drugs that they reviewed in the past three years that in their opinion had been approved too fast.
  • Nineteen medical officers stated that the pressure on them to approve a greater proportion of new drugs was “somewhat greater” or “much greater” compared to the period prior to 1995. The sources of this pressure were identified as the Office Director, Center Office, the pharmaceutical industry, the Congress and the medical officers? own Division Directors.

    “For FDA officials to ignore this information from its own medical officers is to continue on the current perilous course in which far too many me-too drugs are approved, despite questions about their safety or efficacy, only to be banned after enough people are injured or killed,” Wolfe and Lurie concluded.