US FDA Plans For Internet Drug Info And Medguides

The proposal for Medguides, the current version of the patient package insert, is a major priority for US Food and Drug Administration Commissioner David Kessler, according to Ilisa Bernstein, senior science policy advisor at the FDA's Office of Policy, speaking at the Food and Drug Law Institute's annual Pharmaceutical Update meeting (Marketletter May 27).

Neither PPIs nor current rules about promotion of off-label uses of drugs interfere with the practice of medicine. However this may change, depending on how current FDA reform proposals play out, she said.

The FDA has set itself an ambitious program with the Medguides, said Helen Torelli, assistant general counsel at Johnson & Johnson; they will require scientific accuracy, consistent format, a nonpromotional tone, legibility and comprehensive, understandable language. They would be voluntary, but performance standards requiring inserts for 75% of products five years from issue of the final rule and for 95% 11 years out must be met or mandatory requirements would take over.