November 2, 2006

The FDA's warning letter system is flawed and must be revised, according to a report released by the Washington Legal Foundation (WLF).

The FDA is abusing its authority by sending warning letters indiscriminately, without sufficient evidence, the report's author, Larry Pilot, said. "It is probable that most recipients are in reasonable compliance with laws and regulations administered by the FDA, and that the FDA does not possess the evidence to support the issuance of most warning letters."

Pilot called for the FDA to conduct a "major revision" of the warning letter system with congressional oversight. Until then, he said, the FDA should not send warning letters unless it has sufficient supporting evidence. He also recommended the FDA give warning letter recipients 15 working days to respond before publishing a warning letter, and that the reply be published along with the letter at the company's request.

He cited a specific incident showing why the warning letter system should be revised. It involved Utah Medical Products, which received a warning letter in September 2001 saying the agency had found good manufacturing practice violations during an inspection three months earlier. After unsuccessfully trying to settle the dispute, the company filed a complaint against the FDA in the U.S. District Court for the District of Utah in 2004.

In October 2005, a judge dismissed the case and rejected the FDA's position. Pilot said the decision shows that claims in warning letters may not stand up to a thorough legal analysis, and that more companies should defend themselves.