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PDUFA Witness List Revealed, Hearing Set for Wednesday

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By Alexander Gaffney

The US House Energy and Commerce Committee’s Subcommittee on Health is set to hold a hearing on Wednesday, 1 February on the reauthorization of the Prescription Drug User Fee Act IV (PDUFA), which is set to expire later this year. The hearing, entitled “Reauthorization of PDUFA: What It Means for Jobs, Innovation, and Patients”, will feature:

  • Commissioner of the US Food and Drug Administration (FDA) Margaret A. Hamburg, MD
  • President of Pfizer’s Specialty Care and Oncology unit Geno Germano
  • President of the California Healthcare Institute Dr. David Gollaher
  • Chairman and CEO of Alkermines Richard Pops
  • Director of Medical Programs for Pew Health Group Mr. Allan Coukell
  • Vice President of Public Policy for National Organization of Rare Disorders Ms. Diane Edquist Dorman
  • Senior Vice President of Scientific and Regulatory Affairs for Pharmaceutical Research and Manufacturers of America Dr. David E. Wheadon
  • Chair of the American Academy of Pediatrics’ Committee on Drugs for Oakwood Hospital and Medical Center Dr. Daniel A.C. Frattarelli

The hearing will also focus on reauthorization for the two prominent pieces of pediatric drug legislation, The Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act. The hearing will start at 10:00 am in room 2123 of the Rayburn House Office Building.





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