FDA to Ease Off-Label Marketing Rules
February 19th, 2008 joshua
The Food and Drug Administration has issued a draft of rules drug and medical device makers can follow if they wish to disseminate information on their products for non-FDA approved use.
Prior to September 2006, these companies could do this under the umbrella of the FDA Modernization Act. At that time, however, the Act expired and the oversight group has spent the time drafting a similar rules set.
The draft recommends to drug/device makers guidelines the companies should follow when distributing scientific or medical journal reprints, according to the article published at MedicalNewsToday.com.
The FDA recommends these companies ensure conflicts are not involved in the media they’re distributing. The material should be published by an organization with an editorial board. Any conflict should be disclosed immediately. Also, the article should be peer-reviewed.
Manufacturers of the drugs or device in question should not have sponsored any study the company plans to use as promotion for “off-label” use of a device.
Ultimately, the FDA will have the legal authority to decide whether an article is classed as promotion for an unapproved use, or if it causes a drug or device to be misbranded or adulterated under the Federal Food, Drug and Cosmetic Act.
