Congress approved the FDA Amendments Act of 2007 (FDAAA) in September after a lengthy debate that resulted in compromises on many issues. The resulting law contains numerous provisions designed to better inform the public about drug safety and provides new tools for FDA to reduce risks and unsafe drug use.

COMPLEX BILL

FDAAA contains at least 200 specific provisions, according to FDA Commissioner Andrew C. von Eschenbach, MD. The passage of FDAAA grants FDA the authority to control drug marketing and labeling, to require postapproval studies, to establish active surveillance systems, and to make clinical trial operations and results more visible to the public. A key provision allows FDA to require a Risk Evaluation and Mitigation Strategy (REMS) for drugs associated with greater safety risks. Under FDAAA, manufacturers will continue to receive incentives to conduct pediatric studies on drugs and medical products.

The implementation of FDAAA establishes the Reagan-Udall Foundation, which is intended to award grants to scientists engaged in projects related to FDA's Critical Path Initiative. The foundation will be chaired by Mark McClellan, MD, PhD, director of the Engleberg Center for Health Care Reform at the Brookings Institution, Washington, District of Columbia, and former FDA commissioner and administrator of the Centers for Medicare and Medicaid Services.

BALANCING REQUIREMENTS

Requesting a REMS

To avoid drawn-out negotiations over labeling changes, FDAAA establishes a detailed procedure for FDA to request certain revisions to approved labeling and for manufacturers to respond. If the company disagrees with FDA's proposed revisions, a multistep review is conducted and both sides work through a dispute resolution process that includes specific time frames.

FDAAA also grants FDA the authority to require postapproval studies; the manufacturers must complete the necessary research in a timely manner If marketed medications are associated with new potential risks, FDA can require labeling changes or additional research to address these risks. FDA and manufacturers will establish a mutually accepted schedule for completing the required research, and the agency will receive periodic reports from the manufacturers regarding the status of the research and any potential impediments to meeting research deadlines.

Manufacturers that fail to make requested labeling changes or to conduct timely postmarket studies would be in violation of the law and subject to fines. Pharmaceutical companies can also be penalized for failing to implement an approved REMS.

ADVERTISING PREVIEWS

The reauthorization of PDUFA establishes a new voluntary advisory review user fee program for pharmaceutical companies to obtain FDA's opinion on planned television drug ads. In addition, FDA can require a manufacturer to submit a proposed television commercial for review if the agency has concerns about the content. FDA can also require television and radio drug ads to carry a "major statement" of an agent's side effects and contraindications. Manufacturers who air false or misleading advertising can be penalized.

These policies replace an earlier proposal to ban consumer advertising of drugs during the first 1 to 2 years a drug is on the market, as recommended by the Institute of Medicine (IOM) panel and many members of Congress. Some lawmakers objected that even limited advertising bans could violate first amendment rights to free speech.

CONSULTING SAFETY STAFFERS

One goal of FDAAA is to raise the profile of FDA's postmarket assessment activities, a strategy that many policymakers consider important for ensuring appropriate drug use.

There was a push earlier this year on Capitol Hill to add visibility and clout to FDA's postapproval risk assessment activities by establishing a separate drug safety office; however, the idea was opposed by both industry and agency officials because of concerns that it could lead to an unbalanced approach for assessing benefits and risks. Instead, FDAAA mandates that decisions regarding drug safety assessment, such as the need for postapproval studies, be made by new drug reviewers (Office of New Drugs [OND]) and postapproval safety experts (Office of Surveillance and Epidemiology [OSE]). FDAAA calls on FDA to enhance communication between pre- and postmarket review staff members and to report to Congress in 2 years about how well the agency is addressing safety issues identified by OSE.

At the same time, FDA will expand OSE operations with the help of additional user fee revenues earmarked for postmarket surveillance. The PDUFA reauthorization allows user fee revenues to be used to support the costs of safety monitoring of any drug on the market, not just newly approved ones; $30 million in user fees will go to OSE to obtain data on adverse drug events (ADEs).

FDA spokespeople say they envision a "transformation of the drug safety program" by tapping into population-based epidemiological and observational data banks to carry out targeted postmarket surveillance, to look at class effects of drugs, and to better detect safety signals.

Ms Wechsler is a Washington-based reporter specializing in federal and state healthcare issues.