On June 26, 2012, the United States Senate approved the Food and Drug Administration ("FDA") user fee bill, S. 3187, in a 92 to 4 vote. Among the four individuals who voted against the bill, Senator Richard Burr (R. NC) spoke for two hours before the vote. He believed that the bill moved through the voting process too quickly, which resulted in removing language that would have created a track-and-trace system for prescription drugs, a measure he supported. This vote occurred less than one week after the House of Representatives unanimously approved the bill in a voice vote. The bill is now headed to the President for his signature.
This bill will expand the user fee program from brand name drug and medical device manufacturers to generic drug makers and companies producing biosimilars of expensive drugs. It will allow the FDA to collect billions in user fees from 2013 through 2017 which will help the agency pay for reviews of new drugs and devices. This bill was considered necessary legislation, and it is likely the only health-related bill to be passed by Congress before the November election.
For more information, click here. Megan Fanale Engel