Report: FDA Foreign Drug Inspection Program Inadequate

Congressional investigators say it would take 13 years for U.S. inspectors to visit each of 3,249 foreign manufacturing plants that make medications for the American market.

WASHINGTON (AP) -- A lot can happen in 13 years. A new president. Medical discoveries. Economic boom and bust.

But 13 years is also the time it would take U.S. inspectors to visit each of 3,249 foreign manufacturing plants that make medications for the American market, according to congressional investigators.

Their report being released Wednesday concluded that the Food and Drug Administration is nowhere near to closing an oversight gap so foreign facilities get the same scrutiny as domestic plants. Pharmaceutical factories in the U.S. 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 U.S. market, and the large gaps in FDA's foreign drug inspection program, significant challenges remain," the Government Accountability Office said in its report.

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," said Rep. Bart Stupak, D-Mich.

Stupak was among lawmakers pushing legislation to impose fees on drug and food imports that would pay for more inspectors. The Bush administration agreed to a funding increase, but balked at new fees.

An adulterated blood thinner from China put a spotlight earlier this year on the safety of drugs manufactured abroad. Hundreds of frail patients undergoing kidney dialysis and heart operations were sickened by tainted heparin, and some died.

Responding to the report, the FDA said it recognizes that more inspections are needed as part of a broader import safety plan. But the agency questioned the investigators' 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 said.

The report found that the FDA isn't even sure how many foreign facilities are producing for the American market. One government database suggests it's 6,760. Another, which government officials believe to be more accurate, says about 3,000.

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 a year. By comparison, the agency inspected an average of 1,528 domestic plants a year from 2002-2007. There are about 3,000 U.S. 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. 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 said.

When FDA inspectors find problems at an overseas plant, the manufacturers usually take steps to fix them. But the report found that it can take as long as four or five years for the FDA to conduct a follow-up inspection.

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