FDA POLICY TO BE OUTLINED IN JOURNAL

The Commissioner of the US Food and Drug Administration, David Kessler, is reported to be planning to take the unusual step of seeking assistance in the development of FDA policy through publication of an article in a medical journal.

In the article, which is scheduled to appear in a forthcoming issue of The Journal of the American Medical Association, Dr Kessler is expected to seek information from medical practitioners, pharmaceutical manufacturers and other groups to identify the most common and widely accepted unapproved uses of prescription drugs. The article is expected to outline the agency's current position on FDA control of off-label drug uses, and also on proposals to enable agency reviews of significant new uses of approved drugs to be speeded up.

Moreover, notes a report in the Pink Sheet, it will point up Dr Kessler's interest in encouraging the use of existing studies and literature searches in support of approval of off-label indications for certain prescription products.