The explosion in the size of pharma's global supply chain has left the FDA sometimes scrambling to focus its efforts to protect patients from subpar, dangerous and counterfeit drugs and ingredients. In a move to target those players and products that pose the biggest risk, the FDA will give a pass to some companies which don't.
The agency this month kicked off a two-year Secure Supply Chain Pilot Program in which 13 drugmakers will get expedited approval of up to 5 products by agreeing to meet stringent standards. To get in, the drugmakers had to show that they maintain control of the products from manufacture to delivery to the U.S. and can respond quickly to any problems the FDA finds and also rapidly recall any products that fail to make the grade. The program was open to up to 100 companies. FDA spokesman Christopher Kelly said in an email that 15 applied and from those 13 were selected.
Who's in? Some of the biggest makers of branded and generic drugs in the world. Of that baker's dozen, all but two of them are headquartered in the U.S. or Europe. Teva Pharmaceuticals ($TEVA), which is based in Israel and is the largest generics maker by revenue, and Astellas, which is based in Japan, are the exceptions. The 13 are:
- AbbVie ($ABBV)
- Allergan ($AGN)
- Astellas U.S. Technologies
- Bristol-Myers Squibb ($BMY)
- Celgene ($CELG)
- GE Healthcare ($GE)
- GlaxoSmithKline ($GSK)
- Merck ($MRK)
- Mylan Pharmaceuticals ($MYL)
- Novartis ($NVS)
- Pfizer ($PFE)
- Teva Pharmaceuticals USA
- Watson Laboratories
"By creating incentives for manufacturers to adopt best practices for supply chain integrity, we can enhance the quality and safety of imported drugs," Carol Bennett, acting director of the FDA's Office of Compliance, said in a statement. "The program also allows the FDA to focus resources on the areas with the greatest potential risk to consumers."
In the last fiscal year, the FDA got additional dollars to station drug inspectors in countries like India and China that now account for large pieces of the global pharma supply chain but where problems with quality have been a headache for the agency. In fact, the program kicks off the week after FDA Commissioner Margaret Hamburg returned from India, where she met with government and industry officials about cooperating to improve drugmaking standards.
India accounts for 40% of the generic and over-the-counter drugs used in the U.S., but some drugmakers have had long-running issues with quality production. In the past year, the agency has banned products from two plants operated by Ranbaxy Laboratories and two from Wockhardt because of serious lapses. China now makes the active pharmaceutical ingredients for many of the drugs used in the U.S. but has been resistant to having FDA inspectors stationed there. It took a request from Vice President Joseph Biden, during a trip there last year, to get China to start approving visas for inspectors.
- here's the release
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