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Gaps Between FDA Foreign and Domestic Plant Inspections

Oct 22, 2008 | Parker Waichman LLP

about .  The report states that the US Food and Drug Administration (FDA) is nowhere near being close to resolving “a huge oversight gap” that would allow foreign facilities to receive the same scrutiny as domestic plants, according to a piece by the Associated Press (AP).  In the U.S., pharmaceutical plants receive a federal inspection, on average, once every 2.7 years.

The FDA is scheduled to assign inspectors in China and India; however, “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 GAO writes.  The GAO report also “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 Representative Bart Stupak—Michigan-Democrat—chair of the House Oversight and Investigations subcommittee, to the AP.  Stupak is among the group of lawmakers who pushed legislation to impose fees on drug and food imports that would pay for more inspectors.  While the White House agreed to a funding increase, it shied away from the fees.

The FDA told the AP that it recognizes more inspections are needed as part of a broader import safety plan; however, it 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 said to the AP.  Meanwhile, the GAO report revealed that the FDA does not know how many foreign facilities are producing for the U.S. market and, while one government database puts the figure at 6,760, another places it at about 3,000, the AP writes.  The 3,249 figure originates from an FDA list used to set enforcement priorities.  Of those listed, the FDA inspects about 247 yearly.  In the U.S., the FDA said it inspected an average of 1,528 of the 3,000 domestic plants annually from 2002-2007.

The AP reports that Congressional investigators found that the FDA’s rationale for picking which foreign plants to inspect differs from how the agency selects domestic plants.  While domestic inspections involve ongoing surveillance to determine if a plant follows good manufacturing practices, the AP writes, foreign inspections 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, drug makers usually take corrective measures.  The report found it can take up to four or five years for the FDA to conduct a follow-up inspection.


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