FDA scrutinizes old meds that skipped approval

Small drug firms balk at paying for costly trials for medications that sometimes have been in use for years.

By Susan J. Landers, AMNews staff. Feb. 12, 2007.

Washington -- It is a surprise to many of the nation's physicians -- and their patients -- that an estimated 2% of drugs never have been approved by the Food and Drug Administration.

This category of products, which could include thousands of drugs prescribed and sold in the United States, is now the focus of bolstered FDA enforcement activities and an element of the agency's drug safety efforts.

Specifically, the FDA has embarked on an initiative to require that all drugs, even those in use for 15 or 20 years, be backed by scientific evidence of safety and efficacy. The drugs under review are primarily cough and cold preparations with antihistamines, some narcotics and a few types of sedatives, including phenobarbital.

"Americans expect their products to be approved by the FDA," said Steven Galson, MD, MPH, director of the agency's Center for Drug Evaluation and Research. "They don't want products from the dinosaur age of drug regulation." He spoke at a Jan. 9 workshop for manufacturers and other stakeholders to provide information on how products could be brought into compliance.

Several reasons are given for why these drugs are on the market. In some cases, the medicines, which might contain unapproved active ingredients, are older and were in use before the passage of tougher laws, some enacted as early as the 1960s, that require evidence of efficacy as well as safety. In these instances, no company has sought FDA approval for these drugs under the modern system.