Breaking news on off-label promotion and the first amendment

Today the FDA made an announcement. This commenced before the new administration takes office, the FDA released a “memorandum” taking positions on the First Amendment of truthful off-label speech.  However with no particular regulatory significance it may be  an attempt to put agency views on record before the change in administration.   

Dear Readers and Medical Writers:

I  wanted to make you aware that today the FDA made an announcement. This commenced before the new administration takes office, the FDA released a “memorandum” taking positions on the First Amendment of truthful off-label speech.  However with no particular regulatory significance it may be  an attempt to put agency views on record before the change in administration.   

There is a  document to the public hearing titled “Memorandum:  Public Health Interests and First Amendment Considerations Related to Manufacturer Communications” This provides some additional background on the issues the FDA is considering as part of a comprehensive review regarding communications regarding unapproved uses of approved or cleared medical products, including a discussion of First Amendment considerations.

Here is a link to the actual memorandum.  

 Cited from drug and device law

The corporate logo of the U.S. Food and Drug Administration (FDA) is shown in Silver Spring, Maryland, November 4, 2009. U.S. health officials unveiled plans to fight avoidable injuries from medication errors or misuse, a problem that harms hundreds of thousands of people each year and can be deadly. REUTERS/Jason Reed (UNITED STATES HEALTH) - RTXQCTX