The Union of Concerned Scientists surveyed 5,918 scientists working at the U.S. Food and Drug Administration to assess the integrity of scientific decision-making within the agency. The survey included an open-response essay question. Of the 997 FDA scientists who responded to that portion, 20% reported being asked, “for nonscientific reasons, to inappropriately exclude or alter technical information or their conclusions in an FDA scientific document.” More than 40% stated they feared retaliation if they expressed safety concerns publicly.
Concerns were also raised about external influence. Sixty-one percent of respondents reported awareness of instances in which FDA or Department of Health and Human Services political appointees had inappropriately influenced FDA determinations or actions. Sixty percent reported knowledge of cases in which commercial interests attempted to influence, reverse, or modify FDA decisions.
The Union of Concerned Scientists documented several examples illustrating how these pressures may have affected public health decisions. In February 2004, the FDA prevented Andrew Mosholder, a senior FDA safety reviewer, from testifying at a public hearing on antidepressant use and suicide risk in children. According to the House Energy and Commerce Subcommittee on Oversight and Investigations, Dr. Mosholder was instructed to remove risk information from congressional materials and to conceal those deletions.
Another widely cited case involved the antibiotic Ketek. An FDA advisory panel recommended approval in 2001, relying in part on a clinical study later found to contain extensive fraud, including forged patient records and financial incentives for enrollment. Despite subsequent reports of serious liver injury published in the Annals of Internal Medicine, the FDA continued to reference the original trial. Post-marketing surveillance by the FDA’s Office of Drug Safety later identified more than 100 cases of severe liver injury, including liver failure and deaths.
Additional concerns were raised by David Graham, Associate Director of the FDA’s Office of Drug Safety, who testified that his findings linking a widely prescribed pain medication to increased risk of heart attack and stroke were delayed or suppressed. His analysis estimated tens of thousands of excess cardiovascular events associated with the drug.
Taken together, these findings do not negate the value of regulatory science, but they do highlight documented challenges involving political pressure, commercial influence, and internal dissent within regulatory agencies. Independent review, transparency, and post-marketing surveillance remain critical components of protecting public health.
Information obtained from www.ucsusa.org
