Some FDA Scientists Feel Pressured into Drug Approvals

Article excerpt

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. …