Shift in enforcement halves FDA warnings

Think the FDA has been falling all over itself to issue warning letters lately? Think again. A look at agency statistics showed that the number of warning letters actually dropped by half--yes, half--in the last 10 years. Apparently, when FDA changed its rules in 2002, requiring all warning letters to go through its chief counsel's office, the number of missives immediately dropped. In fiscal 2001, the agency sent 1,032; in 2002, it dispatched 538, and and in 2003, 471.

Agency chief Andrew von Eschenbach says that the difference lies only in the seriousness of the letters sent. In the past warning letters were sent out for minor as well as major problems; now they're reserved for serious concerns, he said. And David Elder, enforcement guru at the agency, said counting letters is at best a simplistic measure of its performance. But ex-FDA head David Kessler told the Wall Street Journal that the number of warning letters has "always been one of the surrogate measures of FDA's enforcement performance...[A]ny significant drop raises significant questions."

- see the NYT piece

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