Top 10 Regulatory Issues for Today’s Drug Developers

September 11, 2015 Peter J. Pitts



Not counting my wife and kids (and Sammy the Dog), the list of what’s keeping me up at night, excited, thinking, and rolling up my sleeves is a panoply of public health issues.  The first batch is focused on the FDA (not surprising, since I’m a former FDA Associate Commissioner and currently run the Center for Medicine in the Public Interest).  In no particular order here’s my top 10:

  1. The FDA’s new Super Office of Pharmaceutical Quality. CDER Director Dr. Janet Woodcock calls OPQ a “regulatory revolution.”
  2. The New Risk/Benefit Equation. If you can’t measure it then it doesn’t count. And the yardstick keeps moving.
  3. 21st Century Pharmacovigilance. In the age of social media and global communications, what are the new best practices for a holistic safety reporting process?
  4. 21st Century Cures. One codicil would allow the FDA to cut out the third phase of some clinical trials if the pharmaceutical showed significant effectiveness in Phase II. Now if only the bill can get through the other Phase II – The United States Senate.
  5. Off-Label Communications. Will there be a new guidance? If so, when? Wither the Caronia and Amarin decisions?
  6. Patient-Focused Drug Development. What’s next? How can patients help drive development and a more 21st-century regulatory strategy?
  7. Biosimilars. Remember – there are four different kinds. And what about interchangeability? Physician Notification? Switching? Label Extrapolation? Nomenclature?
  8. Bioequivalence. It’s a brand new world with differential ranges for narrow therapeutic index products. Where are you on the PK (Pharmaceutical Knowledge) curve?
  9. PDUFA Reauthorization. Now’s the time for interested voices to be heard. Can we really settle for just “fast and clean?”

And then there’s the Big Kahuna question:

  1. Not Price, but Value. As Teddy Roosevelt said, “When you’re in a hole, stop digging.” It’s time to talk about value. And there’s a lot to say.

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Authored By: Peter J. Pitts is an authority on global regulatory issues and an Executive Partner at YourEncore. He is a former FDA Associate Commissioner, the Chief Regulatory Officer for Adherent Health Strategies, and the President of the Center for Medicine in the Public Interest, a policy institute he founded in 2004.


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