FDA "strengthens" Advisory Committee process
FDA announced today it will act to safeguard the integrity of its advisory commitee process "to provide greater clarity and transparency in the disclosure of waivers of relationships that could present the appearance of conflicts of interest."
Recognizing that important expertise lies outside the realm of government scientists, agencies with scientific policymaking roles (HHS, EPA, DOL, etc.) routinely employ outside advisory panels. With appropriate safeguards they well serve the public interest.
The FDA news release continues:
"The advisory committee process is integral to examining the intersection between medical practice and clinical research, to spark debate about it, and to subject scientific work to close public scrutiny," said Dr. Scott Gottlieb, FDA's Deputy Commissioner for Medical and Scientific Affairs. "Some of the most valuable input often comes from people who are active practitioners but also heavily engaged in clinical research and we need to make sure that we continue to have the ability to recruit top clinical trialists."
FDA believes it is crucial that the public have complete confidence in the integrity of the advisory committee process. Therefore, in the next few months, the agency plans to take the following steps to help ensure that our advisory committees continue to be scientifically expert and independent and that the advisory committee process is transparent:
Issue a guidance identifying more clearly the conditions under which conflict of interest waivers are granted. Currently, for example, waivers can be granted to committee members under certain circumstances for participation in scientific endeavors related to the work of the committee, as well as for certain unrelated activities. Issue a guidance specifying when waivers of conflict of interest will be disclosed to the public and what information will be made available.
Issue a guidance specifying when briefing materials used at advisory committee meetings will be made publicly available.
Provide greater public dissemination of advisory committee schedules through increased mailings to public groups, and providing electronic notifications through an FDA advisory committee list serve and posting on the FDA web site.
Implementation of a more streamlined approach to the appointment of members to the agency's drug-related advisory committees.
Unfortunately, the plan has an enormous blind spot. As we observed a couple weeks ago when the Journal of the American Medical Association also sought to preserve its integrity:
JAMA's new rules are fundamentally flawed. They limit consideration of financial conflicts of interest to those with funding ties to private industry, totally ignoring the fact that many researchers sustain their professional careers fulfilling the agendas of government health agencies. Major studies can bring in nine-figure grants or contracts and lead to career-enhancing publications, professional visibility -- and more grants. Public health agencies have their own special interests, including promoting favored public health strategies. These are not disclosed and rarely considered. But they're real.
FDA would do well to introduce transparency and safeguards into the process by ensuring that its advisors' funding ties to the Agency itself and to other government funding sources be fully disclosed as well as those to private industry. Whether the dollar is provided by a taxpaying, for-profit organization, a tax-exempt "public interest" organization or a tax-funded agency, we need to recognize that these institutions all have agendas and bias. Full disclosure and rigorous attention to research quality will be required.
