PDUFA discussion drafts released

The U.S. House Energy and Commerce Committee released a discussion draft of PDUFA reauthorization legislation on Wednesday. The Senate Health, Education, Labor and Pensions Committee also posted draft versions of PDUFA legislation.

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 House version includes an additional six month extension for drugs approved along with a companion diagnostic; this provision has been deleted from the Senate version (see BioCentury, March 19). ...