The House Energy and Commerce Committee voted 39-0 to reauthorize the Prescription Drug User Fee Act and Medical Device User Fee and Modernization Act, as part of a package of nine bills it approved Thursday. The committee decided to combine all of these bills into one omnibus package.
The prescription-drug package would reauthorize the prescription drug user fee program through fiscal 2012, expanding the Food and Drug Administrations ability to regulate prescription drug safety. While the agency would have new authority to take actions against drug companies, such as limiting distribution of certain drugs or mandating safety studies, the committee voted to reduce the total amount the FDA would be able to fine drug companies for violations. The FDA would also be able to decide which new drugs should be allowed to enter into postmarket risk-mitigation plans as well as preview direct-to-consumer advertisements.
The legislation also calls for substantial user-fee increases in the drug and medical-device industries. It would increase the total annual prescription drug user fees collected to $392.8 million for fiscal 2008 to enhance pre-market review and post-market safety, providing an additional $225 million in user fees over five years for post-market safety. The bill would also establish a new user-fee program for direct-to-consumer advertising.
The medical-device component would reauthorize medical-device user fees through fiscal 2012, adding two new types of user fees: an annual establishment registration fee and an annual fee for filing periodic reports. The language would allow the FDA to collect $287 million over five years in fees from devicemakers. -- by Jennifer Lubell