Bipartisan Bill Would Relax FDA Conflict-of-Interest Policies
Senators Michael Bennet (D-CO), Richard Burr (R-NC), and Amy Klobuchar (D-MN) introduced a bill last week to override Food and Drug Administration (FDA) conflict-of-interest policies in an attempt to speed up the review of medical products.
bill would reverse guidance
the FDA provided in 2008 stating that it would not permit
experts with conflicting financial interests exceeding $50,000 to participate in FDA advisory committees. FDA advisory committees
provide expert advice and recommendations to the FDA regarding the regulation of food, drugs, medical devices and biological products so that the FDA can make
The Senate bill follows recent reported statements
of FDA Commissioner Margaret Hamburg
that, because of difficulties
finding qualified experts, the FDA was considering loosening its conflict-of-interest rules. Last year, the FDA reported vacancies in 218 of 600 advisory committee positions.
Some manufacturers and lawmakers have argued
that the FDA’s inability to find committee members has contributed to slow product reviews.
In addition, Senator Klobuchar has argued that the regulations are curtailing
job creation and hindering
patients’ access to lifesaving products.
Groups such as the National Physicians Alliance
and Project on Government Oversight
have asked the FDA not to change its conflict-of-interest policies. They argue
that these policies are necessary to ensure that advisory committee decisions remain objective and free from corrupting influences. They also argue that neutral experts are not as elusive as the FDA has implied, citing studies
finding that approximately 50 percent of experts do not have industry ties, and that, in recent years, the FDA has not granted conflict-of-interest waivers to more than 5 percent of committee members. The FDA is permitted to grant such waivers to 13 percent of members.
Supporters of changing the conflict-of-interest rules reportedly contend
that there is a weak relationship between rates of conflicted experts and drug approval decisions. For example, a study
published in the Journal of the American Medical Association
of 221 advisory committee meetings concluded that removing conflicted committee members did not change the majority vote on drug approvals.
The Senate bill’s sponsors argue
that reform is imperative to the FDA’s role as a “driver of the global economy.” They cite
evidence indicating that, under current FDA regulations, life sciences investors are 40 percent more likely to shift their operations overseas.