Legislation seeks to speed FDA review of medical products.
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.
Their 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 final determinations.
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.
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.