This article is more than 5 years old. Information may no longer be current.
FDA proposes new drug information guidance
The FDA has issued a proposed guidance for the dissemination of information about unapproved uses of FDA-approved drugs and devices.
Under the draft proposal for “Good Reprint Practices,” drug and medical device manufacturers would be permitted to distribute medical and scientific journal articles describing unapproved uses of their products to physicians.
“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,” Randall Luther, FDA deputy commissioner for policy, said in a press release. “This guidance also safeguards against off-label promotion.”
Similar guidelines had previously been set forth under Section 401 of the FDA Modernization Act. In this instance, as long as manufacturers met each of the guidelines set forth by the FDA, the dissemination of such materials was not considered as evidence of having the intent to promote a product for off-label use; however, Section 401 expired on Sept. 30, 2006.
The newly proposed guidance also includes several recommended principles for manufacturers to follow when distributing scientific and medical journals or publications.
These include ensuring that the article or reference material being distributed is published by an organization with an editorial board. The organization would then fully disclose any conflicts of interest or biases that the authors, contributors and editors may have.
Any article distributed for the purpose of disseminating information on unapproved product use should also be peer-reviewed and published in accordance with specific procedures, according to the guidance.
The FDA guidance recommends against the distribution of special supplements, as well as any publication that has been funded by one or more of the manufacturers of products mentioned in the article. Additionally, any article that is not supported by credible medical evidence is considered false and misleading and should not be distributed.
The FDA holds the authority to determine whether the distribution of an article or publication constitutes the promotion of an unapproved new use and whether such activities could cause a product to be considered misbranded or adulterated under the Federal Food, Drug and Cosmetic Act. – by Cara Dickinson
For more about the new guidance, as well as for information regarding where to submit public comments, visit www.fda.gov.
Doctors need all the good, reliable information that they can get. Publications from peer-reviewed journals should be extremely valuable to doctors who often don’t have the most recent data at their fingertips. The other side of this issue is the fact that this process can be misused. The FDA has proposed some thoughtful guidelines that should be helpful if followed. The controlling factor in this will occur in court. In recent years, companies have found that, if they promote drugs inappropriately, they are going to get sued. Most companies are now recognizing that it is good business to make really good information available to doctors. It is a bad business decision if they give information that could hurt patients because it will also eventually hurt the company.
– Raymond Woosley, MD, PhD
CEO, The Critical Path Institute, Tucson, Ariz.
I personally think that the relaxation of FDA rules on articles involving nonindications is a good thing, and limiting it to peer-reviewed, nonsupplement issues, which are usually sponsored by industry, makes sense.
– Samuel M. Silver, MD, PhD
Director of the University Cancer Center Network
University of Michigan Cancer Center in Ann Arbor, Mich.