PDUFA VI -- Are you ready to rumble?

  • by: |
  • 06/19/2015

Did somebody say “PDUFA VI?”

With the upcoming PDUFA renewal, 21st Century Cures uncertainty, and a leadership transition at FDA, it is a dynamic and uncertain time in the biopharma industry. The outcomes of these key policy debates, along with others, will impact how industry pursues drug development and works with patients and regulators to improve public health.

To advance the conversation and propose practical ways forward, a panel of regulatory experts, including former industry and FDA leaders, got together in Boston on May 20, 2015 to share their best thinking on pressing regulatory policy issues. And there was also a fair degree of  appropriate (and useful) venting.

The panel was chaired by Tim Franson, MD (Chief Medical Officer for YourEncore, Board Member for the Critical Path Institute, and current President of the USP Convention. Tim was a key contributor to PDUFA V, particularly as it relates to rare disease incentives, and is generally considered one of the  “founding fathers” of the PDUFA concept.

Panelist #2 was Joe Lamendola, Ph.D., the former VP of U.S. Regulatory Sciences for Bristol-Myers Squibb, responsible for over 20 global approvals across 10+ therapeutic areas. Over a 25+ year career, Joe also led the Regulatory Policy and Intelligence Organization for BMS, which was responsible for assessing and influencing regulatory policies, including PDUFA V and multiple therapeutic guidances.

And rounding out the panel was yours truly – the junior associate.

It’s called a regulatory RANT (Relevant Assessment and New Trends) and is a great read to get ready for PDUFA season. The full document can be found here. It's an entertaining and informative read with some relevant assessments and aggressive suggestions

Get ready. Get set. Go!


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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