Senate Committee To Consider Prescription Drug User Fee Reauthorization Bill

April 18, 2007 – 1:53 pm | posted in Pharma Industry

The Senate Health, Education, Labor and Pensions Committee on April 18 plans to consider a bill (S 1082) that would reauthorize the Prescription Drug User Fee Act, which will expire on Sept. 30, CQ HealthBeat reports. The legislation, sponsored by committee Chair Edward Kennedy (D-Mass.), would implement a proposal from FDA and the pharmaceutical industry (Reichard, CQ HealthBeat, 4/12). The proposal, which FDA submitted to Congress on March 16, would increase by 29% the annual user fees paid to the agency by pharmaceutical companies. Under the proposal, pharmaceutical companies in fiscal year 2008 would pay the agency about $393 million in user fees, compared with $305 million in FY 2007. FDA would use about $30 million of the additional funds to improve oversight of prescription drug safety. In addition, FDA would use almost $12 million of the additional funds to cover rent and other costs related to the move to a new facility in Silver Spring, Md. FDA would use $4 million of the additional funds to purchase technology that would allow pharmaceutical companies to submit applications for new medications electronically. FDA would use $6.3 million of the additional funds to hire 27 staff members to review direct-to-consumer television advertisements for medications before they air. FDA also would use $4.6 million of the additional funds to hire 20 staff members to advise pharmaceutical companies on improved clinical trial designs and use some of the funds for work with outside researchers to develop “biomarkers” that would help the agency determine whether medications are safe and effective (Kaiser Daily Health Policy Report, 3/29). Other Provisions
The bill also includes provisions drafted by Kennedy and committee ranking member Mike Enzi (R-Wyo.) related to the improvement of prescription drug safety, pediatric medical devices and the elimination of conflicts of interest among members of FDA advisory committees. In addition, the legislation would reauthorize a law under which pharmaceuticals 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. The legislation does not include a provision that would allow FDA to approve generic versions of biotechnology medications. “Boosters of the products, also known as ‘follow-on biologics,’ had hoped to include such provisions in the prescription drug user fee bill because it is widely viewed as legislation that must be passed this year,” CQ HealthBeat reports. A Kennedy spokesperson said that lawmakers might add such a provision to the legislation (CQ HealthBeat, 4/12).

“Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

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