Union of Concerned Scientists Decries Corporate Interference in FDA Decision Making

Scientific agencies like the US Food and Drug Administration (FDA) are under increasing pressure from "corporate abuse" of the political and legal processes, claims a new report from the Union of Concerned Scientists (UCS).

The report, Heads They Win, Tails We Lose, illustrates a number of case studies in which companies sought to influence-often successfully-FDA decision making by exerting pressure through political and legal channels.

Of note:

• "New Jersey company ReGen Biologics attempted to gain FDA approval for clinical trials of Menaflex, a device it developed to replace knee cartilage. After an FDA panel rejected the device, the company enlisted three members of Congress to influence the evaluation process. In December 2007, Sen. Frank Lautenberg, Sen. Robert Menendez, and Rep. Steve Rothman wrote to FDA Commissioner Andrew von Eschenbach asking him to personally look into Menaflex. Soon thereafter, the commissioner met with ReGen executives and heeded the company's advice to have Dr. Daniel Shultz, head of FDA's medical devices division, oversee a new review. The FDA fast-tracked and approved the product despite serious concerns among scientists. FDA acknowledged its error and revoked approval in 2010."
• "In December 2011, Department of Health and Human Services Secretary Kathleen Sebelius set a dangerous precedent when she overruled more than a decade of analysis by experts at FDA for the first time, and ordered the agency to refuse over-the-counter access to emergency contraception to all women of childbearing age."
• "GlaxoSmithKline, a pharmaceutical company that manufactures the antidepressant Paxil, commissioned five clinical trials from 1998 to 2002 to assess the drug's efficacy in addressing pediatric and adolescent depression. The company published the results of only one trial, which were mixed. The other four trials had found negative results, including that the drug raised the risk of suicide. The company then hampered FDA efforts to investigate by blocking the agency's access to data from the clinical trials, citing confidentiality agreements GlaxoSmithKline scientists had signed."

The report calls additional anti-retaliation protections for government employees, additional data transparency measures, regulatory reforms and improvements to the Federal Advisory Committee Act.

Among the regulatory reforms UCS advocates for: amending the Paperwork Reduction Act, increased resources, better attention to inefficient or ineffective regulations, additional oversight of research facilities, restrictions on the Office of Management and Budget's power to review FDA regulations and the a scientific research registry.

Read more: