Recommendation 5.3 The committee recommends that Congress amend theFood, Drug and Cosmetic Act to require that product labels carry a special symbolsuch 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 existingdrugs. The Food and Drug Administration should restrict direct-to-consumer advertising during the period of time the special symbol is in effect.

Once a drug has been approved by the FDA for marketing, the agency’s regulatory authority over the drug and the manufacturer changes markedly. Prior to approval, the FDA has complete control over decisions about how and by whom the drug can be used and how it is manufactured. More important, the potential for rejection of the application gives the FDA strong leverage in dealings with the company, including, for example, requests for data and negotiation of postmarket commitments. After approval, if the FDA finds problems in the way a product is manufactured or marketed or if it becomes aware of safety concerns, it has two principal options: withdraw approval of the drug, or try to persuade the manufacturer to comply with the agency’s requests. Panel moderator Alta Charo, Warren P. Knowles Professor of Law and Bioethics, University of Wisconsin–Madison, explained that the FDA’s current authority is grounded largely in its mandate to prevent the sale of adulterated or misbranded drugs, and that it is differing interpretations of the phrase “adulterated or misbranded” that lead to inconsistent application of the agency’s authority from one administration to the next. This variation in the application of the FDA’s authority led to the call in the IOM report for clarifying and strengthening the agency’s existing authority to regulate marketed drugs, and for giving the FDA sufficient enforcement tools to ensure that regulatory requirements imposed at or after approval are fulfilled (see the recommendations listed above).

In his presentation, Peter Hutt, Senior Counsel, Covington & Burling LLP, argued that the FDA needs resources, not new legal authorities. This assertion prompted many comments by subsequent speakers and led to debate about the potentially beneficial versus harmful consequences of legally altering the FDA’s authority or enforcement mechanisms.



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