New FDA head outlines agenda
New FDA administrator Mark McClellan last week outlined his top goals for the federal agency, which include speeding market entry of safe medicines, hastening marketing of generic drugs, updating drug manufacturing standards, retaining FDA scientists, and decreasing medical errors, Dow Jones Business News reports. McClellan, who was confirmed by the Senate last month as FDA head but has not yet officially taken over, was speaking at a November 6 conference in Washington, D.C.
Pharmaceutical companies have said that the FDA drug review process has delayed the launch of products on the U.S. market, which they say has led them to submit fewer FDA new drug applications. For example, in fiscal 2002, the FDA accepted 21 new product applications, down from 44 in 1997. The average review period for a new product at the FDA currently averages about 15 months. "There are, I'm sure, a number of reasons responsible for the decline in [new drug] applications in recent years, and one of the things we can do to help address that is to make sure our approval process is working as efficiently as possible," McClellan said.