Senate and House pass PAHPA reauthorization bill
The Senate bill was a slightly amended version of a bill that was passed by the House in January. The House passed H.R. 307 with a vote of 370-28. The bill reauthorizes for an additional five years multiple provisions of PAHPA and the Department of Health and Human Services' Project BioShield, BioCentury reports.
PAHPA established the Biomedical Advanced Research and Development Authority, which awards contracts and grants to develop and purchase medical countermeasures. Project BioShield provides incentives to companies to develop medical countermeasures.
If signed into law by President Obama, the bill would require the U.S. Food and Drug Administration to develop a formal process for regulatory management plans through which companies may obtain scientific feedback on the development and regulatory review of countermeasures that are eligible. In addition, the bill gives the FDA authority during emergencies and threats to extend the expiration dates of products or temporarily approve products for one year that do not meet current good manufacturing practices, BioCentury reports.
The FDA will also be able to waive risk evaluation and mitigation strategies during an emergency.