For years the FDA has been trying to level the playing field in terms of foreign versus domestic drug manufacturing plant inspections. It wasn't many years ago when U.S. facilities could expect a visit every 30 months while foreign plants would go 5 or more years between inspections. One way to achieve parity is to cut the number of U.S. inspections while doing more overseas, and that is what the FDA proposes to do.
The European Medicines Agency is now making public its reports on companies that have failed plant inspections. The FDA has made warning letters and some Form 483 reports public for some years, but the EMA had not, according to Pharmafile, which went through the nearly 7 dozen reports in the data base that date back to 2007.
While most of the discussion of stepped-up inspections by the FDA of foreign manufacturing plants is about the need to keep track of China, it does not mean the industry's biggest players will escape tough oversight. The FDA has sent a scathing warning letter to Novo Nordisk about a plant in Denmark.
The FDA's plan to level the plant inspection playing field by visiting foreign plants at least as often as it does U.S. facilities may not get off the ground in October as planned. Why? Because Congress hasn't gotten around to passing certain legislation needed to trigger it.
The House and Senate must reconcile over the level of supply-chain tracking that will be required of the industry to protect against counterfeit medications.
The FDA likes the look of a program to outsource inspections, but it's caught in one of those pressure sandwiches between competing congressional concerns.