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New Report Confirms That Drug Review Process Doesn’t Protect Consumers; Many FDA Reviewers Say Approval Process Has Worsened

March 31, 2003

New Report Confirms That Drug Review Process Doesn’t Protect Consumers; Many FDA Reviewers Say Approval Process Has Worsened


FDA Should Consider Lengthening Drug Approval Times, Inspector General’s Report Says

WASHINGTON, D.C. – A new report from the U.S. Department of Health and Human Services’ (HHS) Inspector General confirms that the federal government’s current drug review process does not adequately protect consumers from harmful prescription medications, Public Citizen said today. Seven drugs approved since 1996, including Rezulin and Redux (used to treat diabetes and obesity) have been removed from the market because they were deemed unsafe.


According to the report, 40 percent of U.S. Food and Drug Administration (FDA) long-term reviewers responding to a survey conducted by the Inspector General said that the review process has worsened since they were first employed at the agency. The report recommends that in most circumstances, the permitted review period for new drugs, which ranges between six and 12 months, be extended by one to two months.

All new drugs must be reviewed for safety and efficacy before being put on the market. Under legislation that took effect in 1992, drug companies pay “user fees,” essentially paying the salaries of the people reviewing the drugs.

“The FDA is supposed to rigorously screen all new drugs and ensure that they are safe and effective before they are sold to millions of people,” said Peter Lurie, M.D., MPH, deputy director of Public Citizen’s Health Research Group. “Unless the agency gets out of the snug bed it is currently sharing with industry, unsafe drugs will continue to slip through the safety net.”

The centerpiece of the Inspector General’s report is a survey of 401 new drug reviewers in the FDA’s Center for Drug Evaluation and Research. Fifty-eight percent said that the six months allotted for review of priority New Drug Applications was inadequate; 25 percent felt similarly about the target of 10 months provided for review of most standard applications. A priority drug is a breakthrough drug or one designed to treat an unusual condition; a minority of drugs fall into this category.

Eighteen percent of these physicians and scientists felt pressure to recommend that drugs be approved for sale despite their reservations about the drug’s safety, efficacy or quality. (The report does not say who exerted the pressure.) The report concludes: “Overall, these findings present a significant warning signal.”

These findings are consistent with prior research conducted by Public Citizen and the FDA itself. In December 1998, Public Citizen conducted a study (click here to view) showing that 19 FDA medical officers identified 27 new drugs that they had reviewed in the past three years that they thought should not be approved but the agency approved anyway. Seventeen 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. And several medical officers said they had been instructed by their superiors to censor their reports or presentations.

A subsequent FDA survey in 2001 precipitated by high turnover rates among employees in the agency showed that about one-third of medical officers did not feel comfortable expressing differing scientific opinions, and a similar number felt that decisions adverse to a drug were stigmatized within the agency. A number of reviewers said that decisions should be based more on science and less on corporate wishes.

This anti-scientific climate was confirmed in the new Inspector General’s report. Twenty-one percent of those polled indicated that the work environment at the FDA allowed for scientific disagreement to only a small or no extent. The report also indicates that, over time, a lower percentage of drugs, particularly priority drugs, is being presented to the FDA’s external advisory committees, reflecting the speed-up at the FDA and minimizing the opportunity for valuable external peer review.

“FDA’s reliance on user fees from the industry has skewed the drug approval process toward the industry’s financial interests and away from consumer protection,” Lurie said. “Only a purely government-funded agency, as the FDA had been from its origins in 1906 to 1992, can have the independence necessary to keep unsafe and/or ineffective drugs off the market.”

Click here to view the report, FDA’s Review Process for New Drug Applications: A Management Review (OEI-01-01-00590).