Two Senators Introduce Bill To Establish New FDA Prescription Drug Safety Office

Senate Finance Committee Chair Chuck Grassley (R-Iowa) and Sen. Christopher Dodd (D-Conn.) on Wednesday introduced a bill that would establish an FDA prescription drug safety office with more authority to regulate medications after they reach the market, the Los Angeles Times reports. The senators introduced the legislation amid recent concerns about the ability of FDA to monitor prescription drug safety (Alonso-Zaldivar, Los Angeles Times, 4/28).

The bill would establish the Center for Postmarket Drug Evaluation and Research. Under the bill, pharmaceutical companies would have to seek CPDER approval for advertisements for new prescription drugs, high-risk medications and treatments not tested in post-market clinical trials (Henderson, Boston Globe, 4/28). Ads for new prescription drugs would have to include a warning that safety risks remain undetermined for two years after FDA approval.

Under the legislation:

CPDER would have the authority to require pharmaceutical companies to conduct post-market trials of new medications;
CPDER could determine whether safety risks associated with new prescription drugs represent an "unreasonable risk" based on data from post-market trials;
CPDER would have the authority to add warnings and other information to the labels of new medications, restrict distribution and require consumers to sign an informed-consent statement about safety risks (Los Angeles Times, 4/28); and
CPDER could fine pharmaceutical companies as much as $2 million in cases in which they failed to comply with center decisions.

Under the bill, the FDA commissioner would have the authority to overrule CPDER decisions (Philadelphia Inquirer, 4/28). The legislation would allocate $500 million over five years for CPDER (Boston Globe, 4/28). By 2010, CPDER would have an annual budget of $150 million (Los Angeles Times, 4/28).

Prospects

The Senate Health, Education, Labor and Pensions Committee likely will consider the bill (Boston Globe, 4/28). According to the Times, the legislation "goes well beyond the limited reforms announced by the Bush administration and is certain to draw industry opposition" (Los Angeles Times, 4/28). "It was unclear" on Wednesday whether the bill will "gain much support" among lawmakers, the Inquirer reports (Philadelphia Inquirer, 4/28).

House leaders appear to have "little interest in large-scale FDA reforms," according to the Times (Los Angeles Times, 4/28). According to the Inquirer, although Republican lawmakers have "generally been sympathetic to the pharmaceutical industry," recent increases in prescription drug costs have made some lawmakers "more receptive" to legislation opposed by the industry.

Support

Grassley and Dodd said that CPDER would improve the ability of FDA to monitor prescription drug safety. Grassley said, "FDA needs some more tools in its toolbox. It is clear that the interests of the American public and the drug industry can be at odds with one another" (Philadelphia Inquirer, 4/28). He added, "FDA has to be a vigorous watchdog. Some say we need a Rottweiler as opposed to a Chihuahua" (Los Angeles Times, 4/28).

"Consumers shouldn't have to second guess what's in their medicine cabinets," Grassley said. He added that FDA currently is "hampered by real and perceived conflicts of interest" (CongressDaily, 4/27). He said that concerns about prescription drug safety currently are "lost in a maze" (Weisman, Washington Post, 4/28).

Some Concerns

The proposed authority for CPDER "would go well beyond" the Drug Safety Oversight Board, which HHS Secretary Mike Leavitt established in February, the Inquirer reports (Philadelphia Inquirer, 4/28). Leavitt said that the board will provide "the level of independence" required to monitor prescription drug safety.

Senate HELP Committee Chair Mike Enzi (R-Wyo.) also has said that he opposes the establishment of an office such as CPDER, which he said would overstate the safety risks of new prescription drugs and understate the benefits. Enzi plans to introduce an FDA reform bill with Sen. Edward Kennedy (D-Mass.) this summer. Grassley said that his bill could become an amendment to the Enzi legislation (Boston Globe, 4/28).

Additional Reaction

Pharmaceutical Research and Manufacturers of America spokesperson Ken Johnson said, "We have not yet had the opportunity to review the proposed legislation but plan to study it carefully." He added, "Clearly, consumers should be encouraged by steps already taken by the FDA to address drug safety" (CQ HealthBeat, 4/27). Johnson said, "Drug safety is a critically important issue that guides everything we do" (Philadelphia Inquirer, 4/28).

Former FDA Chief Counsel Daniel Troy said that the Grassley bill "raises some very serious constitutional questions" because advertising is protected under the First Amendment. Troy added, "Part of the problem now is that the regulations are totally outdated because they are written for a world where all promotion went to doctors and not direct to consumers" (Boston Globe, 4/28).

Consumers Union Legislative Advocate Jeannine Kenney said, "If enacted, this legislation will be very effective in preventing situations where consumers are taking a drug for years and the FDA has had safety concerns and failed to act" (Los Angeles Times, 4/28).

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