|
|
Current and Breaking News for Professionals, Consumers and Media |
|
|
|
|
|
|
| Current and Breaking News for Professionals, Consumers and Media |
|
|
|
|
|
Agency accepting public comments 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. The FDA's “Good Reprint Practices” draft guidance recommends principles manufacturers should follow when they distribute scientific or medical journal reprints, articles, or reference publications. Some of the principles include ensuring that the article or reference be published by an organization that has an editorial board. The organization also should fully disclose any conflicts of interest or biases for all authors, contributors or editors associated with the journal article. Articles should be peer-reviewed and published in accordance with specific procedures. In addition, the draft guidance recommends against distribution of special supplements or publications that have been funded by one or more of the manufacturers of the product in the article, and articles that are not supported by credible medical evidence are considered false and misleading and should not be distributed. The FDA retains legal authority to determine whether distribution of an article or publication constitutes promotion of an unapproved “new use,” or whether such activities cause a product to be considered misbranded or adulterated under The Federal Food, Drug and Cosmetic Act. The FDA welcomes public comments on the draft guidance. Typed comments should be submitted within 60 days of the Federal Register notice announcing the availability of the draft guidance. 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 listed in the notice of availability that publishes in the Federal Register. 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. www.HealthNewsDigest.com Top of Page 
|
Contact
Us | Job Listings
| Help | Site
Map | About Us
Advertising
Information | HND
Press Release | Submit
Information | Disclaimer
Site hosted by Sanchez Productions
