Some last-minute changes to the Act may also create serious legal problems for pharmaceutical companies. The final bill contains murky language about whether FDA regulations pre-empt states' drug-labeling laws. This thorny issue has pitted federal regulators against states eager to establish more stringent disclosure policies for medical products. The vagueness of the FDAAA provision is expected to lead to a major legal battle on this topic, which may well end up before the Supreme Court.

Balancing the rules

The main elements in the FDA legislation for enhancing medical-product safety have been known for several months (see "Enhancing Drug Safety," in the September 2007 issue of Pharmaceutical Technology). However, many important decisions were made only at the end of the debate. There had been uncertainty about which activities would be part of the new Risk Evaluation and Mitigation Strategy (REMS) program, and which new requirements would apply to all drugs.

Weighing REMS and other remedies

Similarly, the legislation authorizes FDA to require pharmaceutical companies to seek agency prereview of planned TV ads. And it requires all drug TV and radio commercials to include a "major statement" of a drug's side effects and contraindications. This policy is much more agreeable to manufacturers than an alternative proposal to ban consumer advertising of drugs during the first year on the market. The Institute of Medicine panel that examined FDA drug-safety oversight backed a moratorium on new drug advertising, as did many members of Congress. But the likelihood that even a limited advertising ban would violate first amendment rights to free speech persuaded the lawmakers to adopt the prereview option instead.

Giving FDA authority to require postapproval studies, labeling changes, and risk disclosure in DTC advertising for all drugs reduces the need for the agency to impose the REMS policy broadly, explains attorney Scott Lassman of WilmerHale. Instead, FDA gains more authority to obtain additional drug-safety information and to inform the public of emerging safety issues. Moreover, manufacturers that fail to make requested labeling changes or to conduct timely postmarketing studies would be in violation of the law and subject to civil monetary penalties. Pharmaceutical companies also could be penalized for failing to implement an approved REMS, failing to register clinical trials appropriately, and for airing false and misleading drug advertising. These policies aim to boost public confidence in FDA's ability to obtain needed information about drug risks and to enforce appropriate drug marketing and distribution practices.

Consulting safety staffers

An important strategy for policymakers anxious to ensure appropriate drug use is to raise the profile of FDA's postmarket assessment activities. Some members of Congress believe that FDA has been slow to respond to emerging drug-safety concerns because agency staffers responsible for postmarket safety evaluation have been ignored and marginalized by the offices that evaluate and approve new drugs for market. Earlier this year, there was a push on Capitol Hill to establish a separate drug safety office at FDA to give postapproval risk-assessment activities more clout. But both industry and agency officials opposed the idea as likely to disrupt a balanced approach for weighing drug risks and benefits.

Instead, FDAAA specifies in numerous places that important decisions related to drug safety such as the need for postapproval studies or for a REMS should be evaluated by both new drug reviewers (i.e., the Office of New Drugs, OND) and postapproval safety experts (i.e., the Office of Surveillance and Epidemiology, OSE). FDAAA calls on FDA to enhance communication between pre and postmarket review staff and to report to Congress in two years about how well it is addressing the safety issues that OSE identifies.