USA Today reports that industry, consumer and patient groups and the last three secretaries of the Health and Human Services department are joining forces to lobby for more money for the Food and Drug Administration.
Former HHS secretary Tommy Thompson and Michael Jacobson, executive director of the Center for Science in the Public Interest, a Washington, D.C.-based consumer group, are to announce the creation of the Coalition for a Stronger FDA at a news conference today.
The FDA is part of HHS, and “former secretaries probably understand the problem better than anybody else,” Thompson, HHS secretary in President Bush’s first term, said Sunday.
The report concluded that the FDA needs to pay more attention to the safety of drugs once they are on the market, a move that requires both increased funding and regulatory authority.
Among the report’s recommendations: Congress should amend the Food, Drug and Cosmetic Act to require that product labels carry a special symbol for their first two years on the market, when side effects not seen in relatively small pre-approval studies are likely to begin showing up. In addition, FDA should restrict direct-to-consumer ads during that time.
The FDA should evaluate all new safety and effectiveness data about a new molecular entity — a brand-new active ingredient — within five years of approval. The agency needs both the authority and the resources to ensure that drugmakers conduct promised studies after their products are approved. The FDA needs to be able to require labeling changes to reflect new safety information.