At hearings in March before the Senate Health, Education, Labor and Pensions (HELP) Committee, panel chairman Mike Enzi (R-WY) and lead Democrat Edward Kennedy (D-MA) discussed developing bipartisan legislation to address a range of proposals. Kennedy complained that it took five years for the public to learn that Vioxx may double the risk of heart attack or stroke, while user fees allow FDA to review new drugs quickly. But Kennedy also agreed with Enzi that "overreacting could be as dangerous as doing nothing," and that it is critical to "find the right approach."
Even if Congress decides to leave FDA drug safety oversight structurally intact, reformers are pressing for a number of additional changes that would give FDA more clout:
Require sponsors to complete post-approval studies Kweder also supports policies allowing FDA to require a clinical trial to address specific safety issues that emerge after a drug is on the market. FDA now can mandate additional studies only for those drugs approved under its accelerated approval process. The agency can ask a sponsor to conduct certain Phase IV trials, but cannot do much if the marketer fails to keep its commitments— not an uncommon circumstance.
Boost FDA authority to remove problematic drugs from the market Most drug withdrawals are voluntary, although they often occur as a result of FDA urging. The agency has to show that a drug poses an imminent risk to pull it off the market, and that's usually difficult to do. Several proposals would give FDA authority to levy fines or impose other penalties on marketers that fail to comply quickly to post-approval safety concerns.
Expand information on clinical trials Congress wants to strengthen and expand clinical trial registries to better inform the public about investigative drugs under study; there also is a push for public disclosure of clinical trial results, including those that end up producing unfavorable results.