We haven't digested it yet, so this isn't a substantive post, but we wanted to make our readers aware that today the FDA made an announcement, which states in pertinent part:
We have also added a document to the docket for the public hearing titled "Memorandum: Public Health Interests and First Amendment Considerations Related to Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products," which provides additional background on the issues the FDA is considering as part of our comprehensive review of our rules and policies relating to firm communications regarding unapproved uses of approved or cleared medical products, including a discussion of First Amendment considerations. We are requesting input on the Memorandum as it relates to the questions set forth in the initial notice of public hearing.
Thus, two days before a new administration takes office, the FDA has released an official document, albeit a "memorandum" with no particular regulatory significance, taking positions on the First Amendment protection (or more likely, lack of same) of truthful off-label speech by regulated entities – breaking literally years of silence.
Here is a link to the actual memorandum. We haven't read it yet, but we will – as certainly will many of you. The timing suggests, rather blatantly, an attempt to put "agency" views on record before the change in administration potentially results in a much different approach. Since we know from Wyeth v. Levine, 555 U.S. 555 (2009), that changes in FDA position adversely affects the scope of deference granted that position, the memorandum may also be a preemptive attempt to undercut that different approach in court.
We'll have more to say later.
This article is presented for informational purposes only and is not intended to constitute legal advice.