Personal Injury Law

FDA seeks comments on the new guidelines for unapproved uses of Medical Products

By Brian F. LaBovick, Esq.

Concerned Citizens, Health Care Personnel, the FDA wants your opinion on the new FDA Proposed Guidance for Dissemination of Information on Unapproved Uses of Medical Products. Public Comments will be accepted for 60 days. 

"Articles that discuss unapproved uses of FDA-approved drugs and devices can contribute to the practice of medicine and may even constitute a medically recognized standard of care," said Randall Lutter, FDA deputy commissioner for policy. "This guidance also safeguards against off-label promotion."

Previously, Section 401 of the Food and Drug Administration Modernization Act set out guidelines that allowed the dissemination of information on unapproved uses of FDA-approved products. As long as the guidelines were met by the manufacturers, the dissemination of such materials was not viewed by the FDA as evidence of an intent to promote the product for an "off-label" use. However, Section 401 expired on Sept. 30, 2006.

Comments via the Internet:  go to Docket Number FDA-2008-D-0053 on the Regulations.gov Web site.

Comments via mail:
Submit comments to:
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

All comments should be identified with the docket number, FDA-2008-D-0053. For single copies of the draft guidance, call 301-827-3360 or contact: Office of Policy, Food and Drug Administration, 5600 Fishers Lane, Room 14-101, HF-11, Rockville, MD 20857.

Full post as published by LaBovick Injury Law Blog on February 28, 2008 (boomark / email).