PDUFA in the Red Zone

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  • 02/07/2012

Here’s a blog post originally from the Campaign for Modern Medicines:

Peter Pitts on the Energy and Commerce Committee's PDUFA Hearing

peter_pitts.jpgWe were excited to have the chance to speak with Peter Pitts, president and co-founder of the Center for Medicine in the Public Interest, and get his thoughts on the PDUFA reauthorization hearing held by the Energy and Commerce Committee's Subcommittee on Health last week.

  • What did you think of yesterday's PDUFA hearing?
The good news is that there were no surprises and no fireworks. Both sides of the aisle understand the importance of PDUFA and it's "must pass" status. I was pleased that the perennial question of "should there be user fees?" didn't arise to derail the more important conversations concerning how to return PDUFA back to its most important first principles of both partnership and predictability.

  • Where there any surprises yesterday?
I was surprised at the consensus on the issue of FDA advisory committee conflict of interests. Commissioner Hamburg did a splendid job explaining why the agency needs to have access to the best and the brightest with appropriate (but not overly restrictive) safeguards in place. I was also pleased to see that reauthorization for both BPCA and PREA is likely to be part of the process. What remains to be seen is if Congress can take the next logical (and important) step of making both pieces of legislation permanent.

  • Do you see a consensus forming over the desire not to let PDUFA become a political football?
I hope so. It seems that those who would make PDUFA a political conversation have been neutered by responsible legislators on both sides of the aisle who understand that combining politics and the public health (while a heady brew for headline hungry politicians) is inappropriate and contrary to advancing our national healthcare agenda. One issue that is dead in the water is the politically-driven idea to add comparative effectiveness as a third leg to the FDA process. That bodes well for those who are serious about getting the job done right.

  • What's next for PDUFA?
I don't think we have seen the end of the Christmas tree ornament conversation. I don't even think we've reached the beginning of the end. One of the most contentious issues remaining is the TREAT Act and it's call for a "progressive approvals" pathway. That will be a major conversation as the PDUFA process moves over to the Senate side. I also think we will hear more about more regular Congressional oversight over the promises made in PDUFA -- and specifically advances on a benefit/risk measurement instrument.

  • Do you foresee any hurdles to reauthorizing PDUFA before it expires at the end of September?
I think there's a good chance reauthorization will happen before Labor Day -- but it is neither a foregone conclusion, nor is it an absolutely necessary. It is, however, a worthy goal.

  • Just to remind us, what do you think is at stake in the PDUFA reauthorization?
At stake is a return to PDUFA First Principles, namely predictability and partnership as well as making it possible for the FDA to be a leader in the development and deployment of 21st century regulatory science and the advancement of modern medicines. Success means that the FDA will be able to regain its role as an ally and facilitator in advancing the public health.

  • What do you see as the main concerns for patients in PDUFA?
Only the ability of the FDA to expedite the development, approval and use of safe and effective medicines. Everything else is just commentary.

As you can see, Pitts shares our hopes for a timely reauthorization of PDUFA, and agrees that PDUFA is "must-pass" legislation that is critical to helping the FDA review and deliver safe, effective medicines to patients who need them. We look forward to hearing more from him as PDUFA reauthorization progresses.


Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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