Senate begins debate on prescription drug user fee act reauthorization bill

The Senate on Monday began debate on a bill (S 1082) that would reauthorize the Prescription Drug User Fee Act, which will expire on Sept. 30, with senators expected to propose a number of amendments to the legislation, the AP/Dallas Morning News reports ( AP/Dallas Morning News , 4/30).

The Senate Health, Education, Labor and Pensions Committee earlier this month approved the legislation, which would reauthorize PDUFA through 2012 (Harris, New York Times , 5/1). The legislation, sponsored by committee Chair Edward Kennedy (D-Mass.), in large part follows a proposal that FDA submitted to Congress earlier this year under which pharmaceutical companies would pay the agency about $393 million in user fees in fiscal year 2008, compared with $305 million in FY 2007. The bill increased the amount in the proposal by $50 million.

Other Provisions
The bill includes a provision that would require FDA to establish a system to monitor the safety of new medications for at least three years after approval. Under the provision, FDA would have to review the safety profile of new medications at 18 months and at three years after approval and would have access to public and private databases that track reports of side effects in patients. The provision also would require FDA to monitor the safety of medications approved for new uses for at least three years.

In addition, the legislation includes provisions that would provide FDA with more authority to require pharmaceutical companies to conduct post-market studies of new medications, to revise warning labels and to review television and radio advertisements before they air. The bill also would allow FDA to require pharmaceutical companies to wait two years before they air ads for new medications.

The legislation also includes a provision that would require pharmaceutical companies to register clinical trials of medications in a public database and make all results available. The bill would reauthorize a law under which pharmaceutical companies that test their medications in children can receive six months of market exclusivity. However, the legislation would limit the period of market exclusivity to three months under certain conditions when annual sales of the medications exceeded $1 billion (Kaiser Daily Health Policy Report, 4/19). According to the Congressional Budget Office, the bill would cost $547 million over five years (Reichard, CQ HealthBeat , 4/30).

Potential Amendments
Senate Republicans might propose amendments to eliminate provisions in the bill that would allow FDA to require pharmaceutical companies to wait two years before they air ads for new medications and that would limit the period of market exclusivity for pharmaceutical companies that test their medications in children (Edney, CongressDaily , 4/30). The provision that would allow FDA to require pharmaceutical companies to wait two years before they air ads for new medications "is among the bill's most contentious," according to the Newark Star-Ledger .

Opponents maintain that the provision would block patient access to important information on medications and violate First Amendment rights (Cohen, Newark Star-Ledger , 5/1). In addition, Senate Republicans might propose an amendment to revoke FDA approval of the medical abortion medication mifepristone ( CongressDaily , 4/30).

Sen. Orrin Hatch (R-Utah) might propose an amendment to establish incentives to develop antibiotics effective against resistant bacteria and require FDA to provide physicians with improved guidelines on antibiotic use ( CQ HealthBeat , 4/26). Senate Democrats might propose amendments to add provisions in the bill that would allow FDA to approve generic versions of biotechnology medications and legalize prescription drug reimportation (Young,The Hill, 5/1). Kennedy and Senate Majority Whip Richard Durbin (D-Ill.) might propose an amendment to improve FDA oversight of food safety (Edney, CongressDaily , 5/1). Senators also might propose amendments to discourage petitions to FDA that can delay approval of generic versions of medications and provide a period of market exclusivity to pharmaceutical companies that receive agency approval of new uses for older antibiotics ( Dow Jones , 4/30).