FDA Says It Will Work To Reduce Approval Times for Generic Drugs

The FDA will work more closely with drug makers to prevent problems, such as incomplete study results, that could slow approval times for generic medications, FDA Commissioner Mark McClellan said at a meeting of the agency's science board in Rockville, Md., Bloomberg/Oakland Tribune reports. McClellan said that only 7% of generic drugs win approval the first time an application is submitted, a situation that delays consumers' access to the cheaper medicines. In addition, generic drug reviews usually take about 20 months, while the agency's goal for new drug reviews is 10 months or less. "Many people don't know this, but the actual time to approve a generic drug is longer than trying to approve a new drug, even though it is a less complicated process," McClellan said, adding, "We're going to change that." The FDA will also work more closely with makers of new drugs to "eliminate misunderstandings" that can delay the approval of their products, Bloomberg/Tribune reports. McClellan said that although bringing medical products to the market quickly is primarily the responsibility of product developers, the FDA is responsible for "making sure that our regulatory processes are keeping up with the changes that are occurring in medical technology" (Dooley, Bloomberg/Oakland Tribune, 4/10).