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Challenges for the FDA: The Future of Drug Safety - Workshop Summary
Session 5: Enhancing Postmarket Regulation and Enforcement
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:
Distribution conditioned on compliance with agency-initiated changes in drug labels.
Distribution conditioned on specific warnings to be incorporated into all promotional materials (including broadcast direct-to-consumer [DTC] advertising).
Distribution conditioned on a moratorium on DTC advertising.
Distribution restricted to certain facilities, pharmacists, or physicians with special training or experience.
Distribution conditioned on the performance of specified medical procedures.
Distribution conditioned on the performance of specified additional clinical trials or other studies.
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.
5.3: The committee recommends that Congress amend the Food, Drug and Cosmetic Act to require that product labels carry a special symbol such as the black triangle used in the UK or an equivalent symbol for new drugs, new combinations of active substances, and new systems of delivery of existing drugs. The Food and Drug Administration should restrict direct-to-consumer advertising during the period of time the special symbol is in effect.