Nearly one in five Food and Drug Administration scientists in a federal survey said they were pressured to approve or recommend approval for a drug despite reservations about its safety.
Half of the 400 scientists who participated in this 2002 survey by the Department of Health and Human Services' Office of Inspector General thought that scientific dissent was allowed to some extent. However, less than a third felt the work environment at FDA allowed wide leeway for differing scientific opinions related to new drug application decisions. Only 17% thought the agency had adequate procedures in place to address scientific disagreements.
Parts of the survey had originally been published in a 2003 OIG report on the effectiveness of the FDA's new drug review process. Two groups, the Union of Concerned Scientists and Public Employees for Environmental Responsibility, obtained the complete findings through the Freedom of Information Act process and recently released them to the public.
“The survey raises significant issues about drug safety and ongoing monitoring of adverse health impacts of drugs in the marketplace,” said Kathleen Rest, executive director of the Union for Concerned Scientists. “The scientists' concerns warrant further investigation as Congress reviews drug approval practices at FDA.”
An FDA spokeswoman did not respond to requests from this newspaper for a reaction to the survey results.
In other findings, 66% of respondents did not think FDA adequately monitored the safety of prescription drugs once they were on the market, and only 12% were completely confident that labeling decisions adequately addressed key safety concerns.
Almost 60% thought the 6 months allotted for a priority review of a drug was inadequate. The OIG in its 2003 report on the new drug application process had praised the agency for relying on expert scientific reviewers and for working collaboratively with sponsors. But even with these strengths, “workload pressures increasingly challenge the effectiveness of the review process,” the report said.