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CLSA Wire

CLSA and Covington & Burling Host Member Roundtable with FDA’s Director of the Office of New Drugs (OND) in San Francisco

By Oliver Rocroi and Molly Fishman
Oct. 22, 2019

On Oct 17, CLSA and Covington & Burling, LLP hosted Keith Flanagan, Director, and Maarika Kimbrell, Deputy Director, of FDA’s Office of New Drugs (OND) for a roundtable discussion on drug development. The purpose of the meeting was for FDA to solicit feedback from drug companies about the internal processes, challenges, and modernizations necessary to bring the office up to 21st century standards.

FDA staff focused the conversation around five strategic objectives for feedback:

  1. Where is policy clarity/scientific discussion needed to promote effective drug development?
  2. Targeted therapies are great; what about drug development for common/chronic conditions?
  3. Pros & cons of novel trial designs outside of serious/life threatening disease context?
  4. Where do we [FDA] appear to deviate from guidance?
  5. How can OND promote effective drug development given tension between innovation and risk management?

CLSA has offered to act as a conduit for feedback from any member companies that would prefer to anonymize their comments. FDA has requested feedback in the form of specific examples, as well as broad stroke illustrations of existing challenges, and welcomes any suggestions for improvement where appropriate.

Here are two action items from FDA that you can help with right now:

  • Please consider participating in FDA’s Nov. 7 Public Meeting in Silver Springs, Maryland entitled, “Promoting Effective Drug Development Programs: Opportunities and Priorities for FDA’s Office of New Drugs” to help inform OND’s work. Click here to register for in-person or online participation. See Federal Register Notice for instructions on how to submit comments.
  • Please help OND recruit senior executives to fill the positions needed to continue their important reorganization efforts. Send any inquiries and/or leads sent to ond-employment@fda.hhs.gov.

Questions about the roundtable or want to provide feedback to OND? Email Molly Fishman, Director of Federal Government Relations in our Washington, DC office (mfishman@califesciences.org) and Manny Heer, Senior Director of State Government Relations in our Sacramento, CA office (mheer@califesciences.org).