Policy Brief: PDUFA Update


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The reauthorization of PDUFA V would be good for industry, good for the FDA, and, most importantly, good for patients.

We wrote back in February about how MassBio was working with our member companies, BIO and the Massachusetts delegation to advocate for the prompt reauthorization of PDUFA this session. Today, we’re pleased to share that versions of this bipartisan bill have now passed in both the Senate and the House.

Last week, on the Senate side, there overwhelming passage of the Food and Drug Administration Safety and Innovation Act (FDASIA), which included reauthorization of the Prescription Drug User Fee Act (PDUFA). We applaud Senators Kerry & Brown for their work and leadership on this issue (read more here).

Just yesterday, the House approved user fee legislation that includes the reauthorization of the Prescription Drug User Fee Act (PDUFA) (read more here).

What’s next?

The Campaign for Modern Medicines explains the next steps of PDUFA:

Over the next few weeks, the Senate and the House will now come together in a conference committee to combine the House and Senate versions of PDUFA into a final bill. Multiple members of Congress have expressed their desire to pass PDUFA by July 4th, and we hope that the conference committee will adhere to that deadline. Reauthorizing PDUFA well before it is set to expire at the end of September will ensure that the FDA’s review of new drugs is not interrupted, and that patients access to cutting-edge treatments is not delayed. (Link.)

What does PDUFA V include?

Click here for BIO’s summary of key PDUFA V improvements & recommendations.

Posted on May 31, 2012, in MassBio, Policy Briefs and tagged , , , , . Bookmark the permalink. Leave a comment.

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