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It Would Take How Long To Inspect Foreign Plants?
By Pharmalot
October 22, 2008
How about 13 years? That’s the conclusion of a new report by the General Accountability Office, which notes there are currently 3,249 foreign manufacturing plants that make meds for the US market and would need to be visited.
The report (here it is) concludes the FDA is nowhere near to closing an oversight gap so foreign facilities get the same scrutiny as domestic plants, the Associated Press reports. Pharma plants in the US get a federal inspection every 2.7 years, on average.
Although the FDA will soon be placing inspectors in China and India, “given the growth in foreign drug manufacturing for the US market, and the large gaps in FDA’s foreign drug inspection program, significant challenges remain,” the GAO writes.
The report “confirms that the system deployed by FDA to police (foreign) facilities and keep Americans safe from poorly manufactured drugs is understaffed, overwhelmed and completely inadequate,” Bart Stupak, a Michigan Democrat and chair of the House Oversight and Investigations subcommittee, tells the AP. He was among lawmakers who pushed legislation to impose fees on drug and food imports that would pay for more inspectors. The White House agreed to a funding increase, but balked at new fees.
Responding to the report, the FDA tells the AP that it recognizes more inspections are needed as part of a broader import safety plan. But the agency questions the conclusion that it should apply the same kind of scrutiny to foreign plants as it does to domestic ones.
“The conclusion that FDA should endeavor to conduct foreign inspections based on the same criteria as domestic inspections is…problematic because of the differences in regulatory methodology and resources,” the FDA tells the AP.
The report found that the FDA isn’t even sure how many foreign facilities are producing for the US market. One government database suggests it’s 6,760. Another, which government officials believe to be more accurate, says about 3,000, the AP writes.
The 3,249 number comes from a list the FDA uses to set enforcement priorities. Of those on the list, it manages to inspect an average of 247 annually. By comparison, the FDA inspected an average of 1,528 domestic plants a year from 2002-2007, according to the FDA. There are about 3,000 US facilities.
Congressional investigators found that the FDA’s rationale for picking which foreign plants to inspect is often different from how the agency selects domestic plants. Most domestic inspections involve ongoing surveillance on whether a plant is following good manufacturing practices, the AP writes. Foreign inspections, however, are driven by requirement to inspect a facility before it’s approved to ship medications. The GAO recommended more surveillance inspections of foreign plants.
“It is important that (the FDA) ensure that foreign and domestic establishments with similar characteristics be inspected at a similar frequency,” the GAO report states, adding that, when FDA inspectors find problems at an overseas plant, drugmakers usually take corrective measures. But the report found it can take up to four or five years for the FDA to conduct a follow-up inspection.
