GoodReprintPractices.com is a resource dedicated to understanding FDA regulation of scientific information and drug, biologic and medical device industry practices. As you may be able to tell, this site is a work in progress. Check back regularly.
The current debate about industry dissemination of medical and scientific information in the form of medical journal articles and medical reference texts has a rich and, at times, a controversial history. Industry practices have been criticized as manipulative, untransparent, and profiteering. A number of bad examples have earned this criticism, and yet, there remains a substantial record of good scientific communication practices attributable to industry. As a matter of common sense, the unique knowledge that industry has about its own products compels industry to have a substantial and irreplaceable role in the authoring, publishing, and dissemination of medical product information.
The United States Food and Drug Administration, for its part, has put forth significant efforts to clarify its authority to regulate the industry dissemination of medical and scientific information. Many of its efforts have been met historically with obstacles set down by manufacturers, the courts, and public and congressional criticism. Most recently, on February 20, 2008, FDA issued a draft guidance document to industry entitled “Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices.’’ As expected, the publication of this draft guidance document has been saddled with controversy and criticism. On January 13, 2009, FDA announced the finalization of this guidance document in the Federal Register. The final guidance is responsive to public comments that FDA received from multiple stakeholders. As a result, companies complying with this guidance document are unlikely to be on the receiving end of FDA enforcement for misbranding their products.
Two important things to understand…
- FDA’s final reprint guidance does not allow companies to promote unapproved drugs. Companies and critics take heed.
- FDA’s final reprint guidance is filled with numerous important restrictions that will be difficult to interpret and apply. Companies and critics take heed.
So, this site is dedicated to, among other things, fostering a better understanding of issues related to this guidance document, and to parse through the issues and criticism that has come, and is yet to come, from all angles.
I don’t expect universal agreement to the perspectives and articles that I publish on this website. In fact, I encourage readers to bring to my attention any errors that you detect or perceive, and I will do my best to evaluate your comments and address them. Further, if you would like to contribute an article to this website just shoot me an email at John.Murray@goodreprintpractices.com. Of course your perspectives can always be published through the comments function on this website.
Please stay tuned.