Congress Seeks to Clarify FDA’s Conflict of Interest Rules for Clinical Investigators

Aug 03, 2011   

Last week, the comment period closed for the U.S. Food and Drug Administration’s (FDA) guidance document, “Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by Clinical Investigators.” This draft guidance was developed to address the FDA’s conflict of interest policy for clinical investigators who sit on advisory panels that approve drugs. If finalized, this guidance document will replace a previous version released in 2001.

This push for change is a departure from the attitude about conflicts of interest from four years ago. In 2007, the FDA tightened its conflict of interest policies to minimize industry ties that might sway or garner a panelist’s favor. At the time, the FDA determined that 10 of 32 panelists advising the FDA on a drug, Vioxx, consulted for drugmakers. Nine of those 10 panelists recommended re-introducing Vioxx into the market after the drug was pulled for concerns about heart risk. In response, the FDA strengthened their policies to prevent bias by drug reviewers.

Members of Congress have expressed interest in relaxing the FDA’s rules regarding conflicts of interest. Under the current framework, an expert may not serve on an advisory panel if the expert has any direct or indirect ties to the industry. Some members of Congress view this rule as unnecessarily restrictive and that it stymies the FDA’s approval process.

Critics of the new guidance, however, believe the FDA should try harder to find qualified experts who do not have ties to the industry. Advocates of stronger rules maintain that an investigator’s ties to the industry affect a person’s decision to approve a drug for the market.

A change in the FDA’s conflict of interest policies may impact how advisory panels are assembled and medical drugs are reviewed. Although the FDA is not bound to accept recommendations made by advisory panels, the FDA often follows their advice. This new guidance document and Congress’ pressure to relax conflict of interest policies raise interesting questions about the transparency and objectivity of the drug review process.

Fuerst Ittleman will continue to monitor the progress and status of the FDA’s conflict of interest policies. For more information, please contact us at