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 FDA's plans to expand its inspections in other countries, particularly in China, were to get a boost from new user fees that generic drugmakers are to begin paying Oct. 1 as part of the recently passed FDA reauthorization legislation. Since the fee program for generic drugmakers is new, Bloomberg reports, the FDA needs legislation giving it the authority to collect the fees, something Congress has yet to pass, even as it heads off next week for one of its extended breaks.
Mary Beth Clarke, acting director of the office of executive programs in the FDA's Center for Drug Evaluation and Research tells Bloomberg that the agency intends to start ramping up the program but will have to do it "at a slower pace."
Generic drugmakers are particularly frustrated because they have so much at stake. They are prepared to pony up an estimated $1.6 billion in fees through 2017, including $300 million in the upcoming year. In return the FDA has pledged to cut review times from an average of three years to about 10 months. In addition, the FDA would get the money so that it could increase inspections of foreign drug and ingredient makers to about once every three years from an average of once every 9, Bloomberg reports.
The Generic Pharmaceutical Association has said its members are prepared to go ahead and pay the fees, even if the FDA doesn't have the authority to make them, because they think the program is so important. The House passed a bill, Bloomberg says, that would relieve the situation but the Senate hasn't taken it up and now Congress is preparing to leave until after the Nov. 6 elections.
With an explosion in global API and pharmaceutical manufacturing, the FDA has been hard-pressed to keep up with inspections. There have been some serious problems, like when tainted heparin got into a blood-thinner drug and killed and sickened hundreds of patients in 2008.
- here's the Bloomberg story
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