Special Counsel Letter Ups Pressure On FDA To Bolster Inspections

By Kelly Lienhard / April 2, 2021 at 6:22 PM
The U.S. Office of Special Counsel, an independent federal investigative agency, told President Joe Biden and key congressional committees that a credible whistleblower complaint shows FDA watered down troubling inspection findings in at least four instances at biologics plants in recent years, including at a Merck plant that now produces Johnson & Johnson vaccines. The information comes as FDA already faces pressure to beef up its inspections due to a recent finding by Congress’ investigative arm that the agency’s heavy...


Not a subscriber? Sign up for 30 days free access to exclusive, detailed reporting on drug pricing reforms, Medicaid policy, FDA news and much more.