DOTmed News

June 26, 2012
by Brendon Nafziger , DOTmed News Associate Editor
The U.S. Senate passed the Food and Drug Administration user fee reauthorization bill in an easy 92-4 vote Tuesday. The legislation now heads to the president to be signed. 

The FDA Safety and Innovation Act, or S. 3187, which sailed through the House of Representatives last week, renews the FDA’s user fee program for another five year chunk, starting in 2013. In the program, the FDA collects fees from drug and device makers to help pay for speedier review times. 

…The renewal, which authorizes the FDA to collect some $6.4 billion from the industry, comes with a number changes from earlier user fee programs. It now includes generic drugs and biologics, for instance. It also features tweaks that have been championed by medical device manufacturers. Under the new law, for example, the FDA must measure the time it spends reaching a decision on a device submission by the total time used, rather than in “FDA days.” 
…In return for more transparency and speedier reviews, the amount shelled out by device companies in fees will nearly double, reaching $595 million. But with a bigger budget, the FDA will also be able to hire 208 new reviewers, including 32 full-time employees by the end of the fiscal year, AdvaMed said.