If the promise of more meetings with the FDA and a better shot--though no guarantee--of an accelerated approval for promising new drugs excites you, you'll be glad to hear that the House has put its stamp of approval on the new PDUFA legislation. By voice vote House members eagerly pushed along the new set of regulations, which also includes provisions on new industry fees and regulatory promises to speed up generic drug reviews with a mandate for added overseas inspections.
It now heads to the Senate, where lawmakers appear equally avid to send the legislation on for Obama's signature in a rare display of bipartisan cooperation. The Biotechnology Industry Organization and other industry lobbying groups had a big hand in shaping various aspects of the bill. And it reflects their push to get regulators to open up more to new drugs for unmet medical needs that have proved themselves against biomarkers or other standards in mid-stage studies.
For drug developers, the key part of this new legislation lies in the accelerated approval provisions. The compromise bill also includes the Senate's more limited provisions to extend market exclusivity on certain new antibiotics by an extra 5 years. The industry had sought preferred status for antibiotics to help spur new research and development efforts. A number of biotech companies in the space stand to benefit immediately from that provision.
"I think that the FDA wants it and the industry wants it. That's a pretty compelling case for Congress to move it along," Lisa Swirsky, senior policy analyst at Consumers Union, tells Politico. "And everyone wants to get it out ahead of the election cycle this fall."
- here's the story from Bloomberg
- get the report from Politico