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Kaisernetwork.org / Daily Health Policy Report

Capitol Hill Watch | House Subcommittee Schedules Date To Consider Prescription Drug User Fee Act Bill
[Jun 08, 2007]
http://www.kaisernetwork.org/daily_r...fm?DR_ID=45446

The House Energy and Commerce Health Subcommittee on June 14 plans to consider legislation to reauthorize the Prescription Drug User Fee Act [1] [2] [3] and address FDA oversight of medication safety, CQ HealthBeat reports. In a memo, subcommittee Chair Frank Pallone (D-N.J.) said that the bill would increase the annual user fees paid to FDA by pharmaceutical companies to $392.8 million for fiscal year 2008, an $87.4 million increase from FY 2007.

The increase would allow FDA to improve the review process for new medications and "modernize and transform the postmarket safety system," Pallone said. The subcommittee also seeks an additional $225 million in user fees to improve FDA oversight of the safety of medications after they reach the market (Carey, CQ HealthBeat, 6/7).

In addition, the legislation would:

• Require labels and direct-to-consumer advertisements for new medications to include symbols that indicate recent approval status for two years;
• Allow FDA to require pharmaceutical companies on a case-by-case basis to wait for up to three years before advertising newly approved medications;
• Require FDA to partner with major federal and private health care entities that maintain population databases to examine medication safety data;
• Allow FDA to require pharmaceutical companies to conduct clinical trials of medications after they reach the market, submit DTC ads [direct-to-consumer ] [1] to the agency for approval before they air and place restrictions of distribution and use of treatments;
• Establish trial registries and results databases, as well as financial conflict-of-interest restrictions on members of FDA advisory committees;
• Require pharmaceutical companies to post the results of most trials in a public database (Edney, CongressDaily, 6/8); and
• Allow FDA to award market exclusivity to pharmaceutical companies in exchange for requested pediatric trials of medications.

MDUFMA
As part of the bill, the subcommittee also will consider legislation to reauthorize the Medical Device User Fee and Modernization Act [1] [2] that would increase the annual user fees paid to FDA by medical device companies by 31% in FY 2008 and by 8.5% each subsequent fiscal year through FY 2012. Under the bill, FDA would receive about $287 million in user fees from medical device companies over the five-year period. The legislation also would establish two new fees for medical device companies -- an annual establishment registration fee and an annual fee for periodic reports filed with FDA.

Comments
Pallone on Thursday said that the legislation includes language "raised by both sides" during several subcommittee hearings on FDA oversight of medication safety. "I think we came up with a bill I'd like to see passed in its existing form," he said. Bill Vaughan, senior policy analyst for Consumers Union, said that the legislation "is a huge step forward in improving prescription drug safety."

Ken Johnson, senior vice president for the Pharmaceutical Research and Manufacturers of America, said that he will review the bill and submit testimony to the subcommittee in the near future. He added that PhRMA "strongly supports" legislation to reauthorize PDUFA (CQ HealthBeat, 6/7).

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View entire report: House Subcommittee Schedules Date To Consider Prescription Drug User Fee Act Bill


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