this process leaves potentially critical regulatory action vulnerable to a subjective and highly variable process of exercising individual or agency influence, and to the vicissitudes of changing politics and attitudes toward regulation. That is why FDA’s authorities must be clarified and strengthened to empower the agency to take rapid and decisive actions when necessary and appropriate.

5.1: The committee recommends that Congress ensure that the Food and Drug Administration has the ability to require such postmarketing risk assessment and risk management programs as are needed to monitor and ensure safe use of drug products. These conditions may be imposed both before and after approval of a new drug, new indication, or new dosage, as well as after identification of new contraindications or patterns of adverse events. The limitations imposed should match the specific safety concerns and benefits presented by the drug product. The risk assessment and risk management program may include:

  1. Distribution conditioned on compliance with agency-initiated changes in drug labels.

  2. Distribution conditioned on specific warnings to be incorporated into all promotional materials (including broadcast direct-to-consumer [DTC] advertising).

  3. Distribution conditioned on a moratorium on DTC advertising.

  4. Distribution restricted to certain facilities, pharmacists, or physicians with special training or experience.

  5. Distribution conditioned on the performance of specified medical procedures.

  6. Distribution conditioned on the performance of specified additional clinical trials or other studies.

  7. Distribution conditioned on the maintenance of an active adverse event surveillance system.

5.2: The committee recommends that Congress provide oversight and enact any needed legislation to ensure compliance by both the Food and Drug Administration and drug sponsors with the provisions listed above. FDA needs increased enforcement authority and better enforcement tools directed at drug sponsors, which should include fines, injunctions, and withdrawal of drug approval.


The agency’s timely performance of the required postmarketing safety reviews could be listed as one of the goals associated with PDUFA and reported on in the goals letter to Congress (see Chapter 3).



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