The House Energy and Commerce health subcommittee approved legislation today to reauthorize the Prescription Drug User Fee Act and Medical Device User Fee and Modernization Act. Both bills call for substantial user fee increases in the drug and medical-device industries.
The medical-device legislation as amended 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 new fees would generate about 50% of the total fee revenue. Companies would also have to pay 31% more in fees in 2008 and 8.5% more each subsequent year through 2012. It is anticipated that the $287 million in industry fees collected during the five-year reauthorization period will account for nearly 23% of the $1.2 billion that Food and Drug Administration says it will need to adequately review medical devices.
The prescription-drug package as amended and passed by the subcommittee would authorize an additional $225 million in user fees that would be used mainly for post-market safety activities. Specifically, the amended bill would establish a program to assess and collect new fees for the voluntary review of prescription drug direct-to-consumer television ads.
The full committee is expected to compete work on those bills, along with several other pediatric pharmaceutical and device bills and drug-safety bills, on Thursday. -- by Jennifer Lubell