2014 Was a Good Year for FDA & Pharma Banging Year for Drug Approvals, Wimpy Year for Enforcement Actions
The 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
Download the full article (PDF file) here:
Issue: Vol. 14, No. 2: January 2015