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
For example, the final bill enhances FDA's authority to require labeling changes, additional postmarket studies, and advertising
curbs for all drugs—not just for products that warrant a REMS. Conversely, the legislation stops short of requiring a REMS
for all new drugs, as originally proposed, and leaves it up to FDA to decide whether a drug seeking market approval warrants
added REMS components to ensure that the benefits of a medical product will outweigh its risks (see sidebar, "Weighing REMS
and other remedies").
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