The FDA and generic drug makers reached an agreement that would require the companies to pay at least $299 million per year to accelerate generic drug approvals. Fox News reports that the FDA met with industry groups three times in July to discuss the program. Generic drug makers were more than willing to pay up — since it means faster approval of their products. In fact, some generics companies whose drugs are pending FDA review agreed to front the first-year fees.

The fees will enable the FDA to hire more staff and improve systems within its drug review and inspection processes. In particular, it will bolster the FDA's efforts to inspect foreign manufacturing plants, where most of the ingredients used in U.S. medications are produced.

Congress will still need to give its approval before the generic drug user fees are put into place. The FDA-industry agreements also assume congressional budget appropriations funding the generics review will remain stable.

The negotiations included representatives from the Generic Pharmaceutical Association (GPhA), the European Fine Chemicals Group, and the Society of Chemical Manufacturers and Affiliates Inc.'s Bulk Pharmaceuticals Task Force (BPTF). They represent such companies as Watson Pharmaceuticals, Teva Pharmaceutical Industries, and Mylan Labs.

Comments

Search RSS

All rights reserved."