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JAMA. 2002;288:2678.

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

The FDA has proposed amending its requirements regarding patents for brand-name drugs. If finalized, the proposed rule would (1) clarify that certain types of patents—including those claiming packaging, metabolites, or intermediaries—may not be listed by brand-name drug manufacturers; (2) revise the required patent declaration to help ensure that it includes only appropriate claims; and (3) limit to one a brand-name manufacturer's opportunity to secure a 30-month stay of FDA approval of an application for the marketing of a competing generic drug.

The proposal is designed to make the FDA patent listing process more efficient; prompt brand-name manufacturers to make well-considered representations in their patent declarations; produce greater compliance with FDA patent listing requirements; and speed up the agency's approval process for generic drugs.

The full proposal is available as Docket No. 02N-0417 at http://www.fda.gov/ohrms/dockets/default.htm. Comments may be submitted until December 23, 2002 to http://www.fda.gov/dockets/ecomments. For further information, contact . . . [Full Text of this Article]

Mark B. McClellan, MD, PhD
Commissioner of Food and Drugs