Medical ethicists have worried for years about the growing share of new drugs whose human trials took place in foreign countries where federal auditors could not make sure patients were protected, but no one knew how big the potential problem was.
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'The Inspector General’s report found that the FDA was 16 times less likely to audit foreign sites than they were to audit a domestic site, partially due to the high cost of auditing foreign sites. It’s crucial that the FDA be able to verify that proper clinical procedures are followed. Otherwise, drugs that are unsafe or ineffective could be put on the U.S. market, endangering people’s lives.'
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