House passes bill reauthorizing PDUFA
AstraZeneca commends the US House of Representatives for approving legislation to reauthorize PDUFA, a law that allows the US Food and Drug Administration to collect fees from biopharmaceutical companies to help pay for the regulatory review process of medicines and biological products.
The House vote (387-5) comes a week after the Senate approved similar legislation. Differences between the two bills now likely must be addressed before a final bill can be sent to President Obama.
Passage in both the Senate & House shows strong bipartisan support for PDUFA, which provides much needed resources to the FDA.
AstraZeneca hopes that the resulting legislation will lead to a more efficient, predictable, transparent and well coordinated drug review process within the FDA while strengthening the scientific base at the agency, supporting patient safety and promoting innovation.