FDA Final Rule on Dissemination on Unapproved Uses of Marketed Products

FDA has now issued its final rule implementing the provisions of the Food and Drug Administration Modernization Act ("FDAMA") that permit, in limited circumstances, the dissemination of reprints of articles and of unabridged texts that deal with unapproved uses of approved drugs, biologics, and devices. The rule will appear in the Federal Register tomorrow. FDA decided to proceed despite the fact that the Court in Washington Legal Foundation v. Friedman has not yet ruled on FDA’s motion to clarify that its order does not prohibit FDA from implementing these provisions.
 
Differences between the final rule and the proposal include the following:

• Comparative claims not in the product’s labeling will not be considered a "new use" requiring compliance with the regulation.
• FDA will presume that journal articles and reference publications are scientifically sound, with several clearly identified exceptions, rather than judging each article or publication separately when submitted.
• FDA will permit distribution of unabridged texts that do not meet all of the requirements of the regulation, so long as the company does not focus on or point to a specific unapproved use and includes a disclaimer that the text includes information on unapproved uses.
• FDA will act on a submission within 60 days of its receipt (rather than, as in the proposal, beginning the 60-day period only when FDA judges the submission sufficiently complete to permit substantive review).

 
The document can be found on FDA’s web site
(at http://www.fda.gov/ohrms/dockets/98fr/112098a.pdf).