And Rounding the Club House (and Senate) Turn ...

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  • 04/19/2012

Yesterday the HELP Committee released a draft version of PDUFA legislation and plans a April 25 PDUFA mark-up.

The Senate draft creates a new pathway for review of "breakthrough" therapies, requiring FDA to work with sponsors to expedite approval of products to treat serious or life-threatening diseases based on "preliminary clinical evidence indicating that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints."

On the other side of the Capitol, the House Energy and Commerce Committee released a discussion draft of PDUFA reauthorization legislation on Wednesday. Both the House and Senate bills incorporate the Generating Antibiotic Incentives Now (GAIN) Act, which would extend market exclusivity by five years for drugs that treat antibiotic-resistant pathogens. The E&C version includes an additional six month extension for drugs approved along with a companion diagnostic; this provision has been deleted from the Senate version.

The House draft also seeks to permanently reauthorize two laws that create incentives for conducting clinical trials in pediatric populations, the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act. Similar legislation, the Better Pharmaceuticals and Devices for Children Act, was introduced with bipartisan sponsorship in the Senate on Tuesday; it is likely to be incorporated into the Senate PDUFA reauthorization bill.

House lawmakers said they were optimistic that any outstanding issues in the GOP draft would be resolved in the coming days, and full committee Chairman Fred Upton (R, MI) said he was convinced the panel is on track to meet his goal of approving the legislation by the end of June.


Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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