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Published on 2 November 2007

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Report finds FDA failing to inspect foreign drugs

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The FDA is failing to properly inspect drugs produced by foreign manufacturers, a report claims.

Members of the US House of Representatives energy and commerce subcommittee on oversight and investigations said the FDA’s focus on domestic inspections was putting the public at risk, as more and more drugs now came from overseas.

Nearly all pharmaceutical firms in America are inspected at least once every two years.

But foreign companies can go eight or more years between inspections, according to Congressional investigators.

The law requires domestic inspections to be carried out frequently, but the legislation was drawn up before the explosion in imported drugs, and as such the FDA is not compelled to conduct foreign inspections with any regularity.

Prescription medications and drug ingredients pour into the USA from an estimated 3,000 foreign companies, though the real number could be as high as 6,700, Congressional inspectors said.

The FDA plans to inspect just 300 overseas firms this year, and most are factories that make drugs that are awaiting regulatory approval.

Only 15 companies are subject to assessments to ensure their products are safe in the years following FDA approval, though some inspections also include some post-approval surveillance.

Copyright © PA Business 2007

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