FDA reviewers say many pressed to okay unworthy drugs

Medical Marketing and Media, Jan 1999

A survey of FDA drug reviewers found 19 who said that 27 drugs approved over the past three years did not deserve clearance, Public Citizens Health Research Group reported on December 1. The study, FDA Medical Oficers' Report Lower Standards Permit Dangerous Drug Approvals, charged that the agency's drug safety and efficacy standards have declined in the past few years.

The report also documented 14 instances where an FDA reviewer claimed to have been instructed by a superior "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." One reviewer wrote in the survey that when a specific drug did not meet the reviewing divisions standards, the standards were then "nullified" to permit approval.