Today, the House passed HR 5651, The Food and Drug Administration (FDA) Reform Act. This bill reauthorizes FDA user fee programs and makes necessary reforms to improve accountability at the agency. According to the Congressional Budget Office, the legislation reduces the deficit by $370 million over 10 years.
Reauthorizations in the bill are: the Prescription Drug User Fee Act; the Medical Device User Fee Act; the Generic Drug User Fee Act; and the Biosimilars User Fee Act. The bill also contains reforms to help patients and doctors address current drug shortages.
"This legislation continues important FDA programs, while incentivizing the creation of new and life-saving prescription drugs and medical devices," said US Rep. Sue Myrick (NC-09), Energy and Commerce Committee Vice Chairman. "I am pleased that this bill achieves these goals and has received wide support from both our constituents and industry leaders".
The bill also includes a provision to grant qualifying innovator companies an incentive to bring new treatments for pediatric diseases to market by expanding the FDA's priority review voucher program. This program currently allows a company that develops a treatment for a neglected disease to receive priority review status for another treatment, meaning that the company is better able to get a new treatment to market quickly once the FDA has assured safety and efficacy.
"No parent should have to hear that treatment options for their child are limited because the market for such treatments is too small," said Rep. Myrick following the bill's passage out of the Energy and Commerce Committee's Subcommittee on Health earlier this month. "This bill gives companies an added incentive to create these much-need treatments at no cost to taxpayers, and has the potential to save lives in the process."