On Wednesday, April 25, 2012 at 10:00 AM, the Senate Health, Education, Labor and Pensions (HELP) Committee will have an executive session to do a markup of FDA bills.
These bills include the Prescription Drug User Fee Act (PDUFA) and Medical Devices User Fee Act (MDUFA) Reauthorizations as well as the Generating Antibiotic Incentives Now (GAIN) Act, among others. The bills have been consolidated into a single package known as the Food and Drug Administration Safety and Innovation Act. Chairman Harkin (D-IA) and Ranking Member Enzi (R-WY) are listed as having introduced the bill to the HELP Committee.
Among other things, the proposed bill would extend the legal monopoly for certain antibiotic drugs by 5 years. In the early Senate negotiations on the bill, efforts to eliminate, reform or limit the 5 year extension were rejected, as was a proposal to require more transparency of the costs and benefits of the 5 year extended monopoly.