2014 Was a Good Year for FDA & Pharma Banging Year for Drug Approvals, Wimpy Year for Enforcement Actions
Bang and WhimperThe U.S. Food and Drug Administration (FDA) ended 2014 with a bang and a whimper.

The Agency approved a total of 41 new molecular entities (NMEs) and biologics (BLAs) in 2014, the greatest number since 1996. That was the bang. FDA, however, also ended the year with a whimper. The Agency sent out only a meager 10 advertising enforcement letters in 2014, the fewest ever.

There may be a single explanation for both phenomena: the Prescription Drug User Fee Act (PDUFA) payments to FDA from pharma. These payments now account for more than 65% of FDA’s budget for the approval and regulation of drugs.

Topics (partial list):

  • Orphan Drugs Are “Where the Money Is”
  • Banging Drug Prices
  • Wimpy Enforcement
  • Busy, Busy FDA
  • PDUFA Fees vs. Enforcement

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Issue: Vol. 14, No. 2: January 2015

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