GPhA responds to possibility of more stringent FDA regulations

NEW YORK — A ghost from 2008 soon could come back to haunt 2010.

According to published reports, the Food and Drug Administration may be considering adopting tougher standards for certain classes of generic drugs if it determines that some are not equivalent to their branded counterparts.

FDA Center for Drug Evaluation and Research director Janet Woodcock reportedly told one media outlet that the agency was considering strengthening regulations on some generic drugs on the basis of statements by some patients and employees of generic drug companies that the generics didn’t work as well as the branded drugs. Woodcock’s statement followed a speech given at a technical conference organized by the FDA and the Generic Pharmaceutical Association, though she was reported as not elaborating further.

In 2008, controversy arose amid anecdotal reports that patients taking generic drugs for epilepsy had experienced breakthrough seizures—seizures that occur even when patients are using drugs—which they had not experienced while taking branded versions of the drugs. As a result, legislatures in 35 states considered generic “carve-out” bills that would have placed restrictions on when a generic drug can be used for certain diseases, though only three of them passed.

Following Woodcock’s remarks, the GPhA sought to allay concerns that may have arisen. “As evident from the GPhA/FDA Fall Technical Conference this week, generic industry companies and the FDA share a unique partnership and commitment to assuring consumers and patients that all drugs—brand and generic—are safe and effective,” the organization’s statement read. “In fact, forums such as this conference provide opportunities for all constituents in our industry to seek ways to partner with the FDA to ensure the generic drug approval process is the most stringent in the world. The FDA has the ultimate authority to ensure the safety of the pharmaceuticals in America’s medicine cabinets and to preserve the confidence that consumers place in our products.”