A story published yesterday by Reuters is about a public meeting to be held this summer by the U.S. Food and Drug Administration (FDA).

What’s the topic? It’s whether biopharmaceutical companies and their employees should be allowed to disseminate “truthful and non-misleading” information about use of the companies’ products outside of the products’ approved indications (i.e., “off-label” promotion).

This is a topic that people get very passionate about!

On the one hand, it is absolutely true that the current FDA ban on off-label promotion of pharmaceuticals is an interference into the First Amendment right to free speech. And there is certainly an argument that such restriction is justifiable.

On the other hand, the current mechanism by which clinicians need to go exclusively through the medical affairs departments of individual companies to seek information about the off-label use of individual drugs is very problematic — for physicians seeking such information and for the companies themselves.

From the perspective of a regulator, however, there are bigger questions. There have been numerous examples of cases in which studies appeared to show benefits from the off-label use of a whole range of products … but in most of those cases, the data couldn’t be reproduced in randomized, controlled clinical trials. And then there are the cases in which widespread off-label uses of drugs were shown, later on, to be associated with a significant increase in morbidity and mortality among patients so treated.

It is hard to know how this issue will play out. It is certainly true that physicians and patients need to be able to access and know about treatment options — particularly for those conditions for which there may be few really effective and safe forms of therapy. If some of those options involve off-label use of approved drugs, we do, currently, have a problem in the world of communication. But the public health risks associated with widespread, off-label promotion and use of biopharmaceuticals are very real too.

The Reuters article does a nice job of summarizing the issues. Read it to get the details. As yet we don’t have a date for the proposed public meeting, but if I can swing it I’m planning to be there.

About Mike Scott

Mike Scott is a highly experienced health care communications strategist with Calcium. He is also a board member of three different patient advocacy organizations. To get more detail, see his profile on LinkedIn.

Comments are closed