Senate Committee Approves Bill To Reauthorize Prescription Drug User Fee Act
April 24, 2007 – 2:40 pm | posted in Pharma IndustryThe Senate Health, Education, Labor and Pensions Committee on Wednesday voted 14-5 to approve a bill (S 1082) that would reauthorize the Prescription Drug User Fee Act, which will expire on Sept. 30, through 2012, Dow Jones reports. Earlier this year, FDA submitted to Congress a proposal 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 legislation, sponsored by committee Chair Edward Kennedy (D-Mass.), increased the amount in the proposal by $50 million (Dow Jones, 4/18). However, the bill in general "largely reflects FDA’s proposal," CongressDaily reports (Johnson, CongressDaily, 4/18).
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 postmarket studies of new medications, to revise warning labels and to review television and radio advertisements before they air (Dow Jones, 4/18). The bill also would allow FDA to require pharmaceutical companies to wait two years before they air ads for new medications (Japsen, Chicago Tribune, 4/19). The bill 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 legislation also would reauthorize a law under which pharmaceutical companies that test their medications in children can receive six months of market exclusivity. However, the bill would limit the period of market exclusivity to three months under certain conditions when annual sales of the medications exceeded $1 billion.
Amendments
Before passage of the legislation, the committee voted 11-9 to approve an amendment sponsored by Sen. Tom Coburn (R-Okla.) that would require FDA to regulate medical marijuana as the agency regulates legal mediations (Dow Jones, 4/18). The committee voted 12-9 to reject an amendment sponsored by Sen. Judd Gregg (R-N.H.) that would have required FDA to refer new medications considered to have potential safety risks to academic institutions, which would analyze databases to determine whether the system to monitor the safety of new treatments should apply. In addition, the committee voted 12-10 to reject an amendment sponsored by Sen. Pat Roberts (R-Kan.) that would have revised the provision in the legislation that would allow FDA to require pharmaceutical companies to wait two years before they air ads for new medications. The committee rejected a second amendment sponsored by Coburn that would have revised a provision in the bill that would limit dispensation of medications to certain physicians (Reichard, CQ HealthBeat, 4/18). The committee also rejected an amendment by Sen. Wayne Allard (R-Colo.) that would have eliminated the provision in the legislation that would limit the period of market exclusivity for pharmaceutical companies that test their medications in children.
Generic Biotech Rx
The bill does not include a provision that would allow FDA to approve generic versions of biotechnology medications. However, Kennedy said that such a provision could become part of the legislation after the bill reaches the Senate floor, which he expects will occur in June (CongressDaily, 4/18). House Energy and Commerce Health Subcommittee Chair Frank Pallone (D-N.J.) on Wednesday said that he will not decide whether to include such a provision in the House version of the bill until the committee holds hearings on the issue (CongressDaily, 4/19).
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