House Subcommittee OKs Measure To Extend FDA User-Fee Programs

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On Tuesday, the House Energy and Commerce Subcommittee on Health unanimously approved by voice vote legislation that would reauthorize and modify FDA's user-fee programs for pharmaceutical drugs and medical devices, Politico reports (Norman, Politico, 5/8).

The bill would extend the programs, which are scheduled to expire at the end of September, for an additional five years (Sanger-Katz, National Journal, 5/8). The fees would be used to enhance the agency's approval process for new medical products and aid its efforts to monitor the products once they enter the market.

The measure now proceeds to the full Energy and Commerce Committee, which is expected to mark up the measure on Thursday (Politico, 5/8).

Prospects of User Fee Legislation

House Energy and Commerce Committee Chair Fred Upton (R-Mich.) commended lawmakers for their bipartisan efforts to advance the bill, which has been identified as a "must pass" measure this year. He said the progress is a reflection of Republican and Democratic leaders' "willingness to put partisanship aside to look at issues together." Upton said the bill is on track to be approved and sent to President Obama by the end of June.

The Senate Health, Education, Labor and Pensions Committee last month approved by voice vote similar draft legislation that would reauthorize and modify the user fees programs. On Tuesday, Senate Majority Leader Harry Reid (D-Nev.) said further action on the measure would take place "this work period" (Khatami/Phenicie, CQ Today, 5/8).

Sticking Points Remain

On Tuesday, House Energy and Commerce Committee ranking member Henry Waxman (D-Calif.) expressed concern with a provision in the House measure that would give antibiotic drugmakers incentives, such as five years of additional patent protection against generic drugmakers. The Senate bill would restrict such incentives to treatments for "serious and life-threatening" conditions. Waxman said, "I regret that we failed to narrowly tailor the bill," adding, "As the bill stands now, essentially any antibiotic qualifies" for the incentives.

In addition, consumer groups are continuing to advocate for a provision by Rep. Ed Markey (D-Mass.) that would allow FDA to reject applications for medical devices if there are similarities to defective devices that have been recalled. According to Politico, such language is not included in the Senate measure (Politico, 5/8).


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