Senate overwhelmingly approves FDA guideline revamp
In a bipartisan vote, the United States Senate passed a bill that would reorganize the Food and Drug Administration’s approval process to provide Americans with breakthrough medications and generic versions of pharmaceuticals in a more timely manner. The bill detailing the reorganization of the FDA’s approval process will now go to the United States House of Representatives for vote. The Senate vote to pass this bill, which details a comprehensive overhaul to the FDA’s operating procedures, was nearly unanimous with 96 votes for and a single vote against. The legislation, if made law, would continue the government agency’s policy of collecting fees from the manufacturers of brand name medical devices and pharmaceutical products while also allowing the FDA to collect fees from the manufacturers of generic brand medical products in order to finance the administration’s application review and approval process. The legislation also allows the administration to designate some pharmaceutical products that offer a marked improvement over the current approved treatments for life threatening illnesses as “breakthrough” drugs in order to fast track their development. If made law, the bill would also require drug manufacturers importing their products from foreign countries into the United States to provide additional registration information regarding their production facilities, and increase the severity of penalties for manufacturing counterfeit drugs. In addition, the bill would increase the number of drug manufacturers required to notify the Food and Drug Administration at least six months in advance if they’re running short on key drug components or plan to discontinue the production of specific medical products.