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Volume 0, Issue 0
Is FDA's MO in foreign inspections too broken to fix?
Who should be in charge of inspecting foreign drug plants? There seems to be a gathering consensus that it's FDA's job, and it seems likely that Congress will turn that consensus into law sometime in the next year or two. But is that really the right answer? The current way this country handles the safety of imported drugs and active pharmaceutical ingredients is far from pretty, as a recent study from the Government Accountability Office (GAO) illustrates. But realistically, in the world of drugs, it has worked adequately. Yes, there was the heparin scandal—but by all appearances, that was a case of deliberate and rather sophisticated product adulteration. It is not at all clear that plant inspections would have caught it, or that plant inspections are the best way to prevent a recurrence of that particular problem.
If you read the GAO report, you'll quickly see a good reason to look beyond FDA inspections for a way to regulate imported drugs. FDA, according to the report, currently inspects only about 8 percent of foreign plants each year. At that pace, it can only inspect plants about once every 13 years. That's just an estimate: FDA's databases of foreign manufacturers are in such disarray that no one really knows how many factories send drugs or APIs to the United States. When FDA has issued a warning letter to a foreign manufacturer, follow-up is slow and uncertain. Of the 15 warning letters issued between 2002 and 2007, only four resulted in a second inspection within five years—and three of those were visited not because of the letter but because they had been listed on a New Drug Application.
Admittedly, FDA has been ramping up its inspection program, and CDER head Janet Woodcock has been quoted as saying that it will take two years and a quarter-billion dollars to get foreign plants inspected on the same schedule as US plants. But with all due respect for Janet Woodcock, she's almost certainly wrong. FDA inspections require the rarest of resources—trained and experienced people. The agency will be lucky to achieve that goal in 10 years. After all, GAO performed the same research on FDA inspections, and reached roughly the same conclusions 10 years ago. There may be a greater will to change now, but the job is still enormous.
If we can't have these plant inspections now, then we need another plan—one that can be put in action now rather than in a decade. And if we can come up with such a plan (and of course we can), why should we follow through and make FDA the inspector of the whole world's drug manufacturing?
So, what sort of plan? I'm sure there are a number of ways to go about it, some more palatable to the industry than others, but they will probably include two elements: The company selling the drug in the United States will take full responsibility for anything that goes wrong, giving pharma companies powerful incentives to perform their own inspections and manage their outsources meticulously. And FDA will continue with its program of reaching out to foreign drug regulating agencies to forge agreements on inspections and standards. Congress might want to take the extra step of banning imports from countries that don't have such an agreement or whose inspections don't live up to FDA standards.
Congress needs to be realistic. It will take years for FDA to build up the capacity to inspect foreign plants. The country can't wait. And we don't need to. The right solution for this problem is the one that works now.