Video - Off-label communications

In The News
March 13, 2017

Kellie Combs, Ropes & Gray life sciences partner, analyzes three documents released by the FDA outlining the agency’s current thinking regarding drug and device manufacturers’ communication of information not contained in FDA-approved labeling.


On Wednesday, January 25, FDA issued a Memorandum on Public Health Interests and First Amendment Considerations Related to Off-Label Communications about drugs and devices.  The memo was framed as a follow-up to a public hearing that FDA had held on off-label communications back in November. At that hearing, I testified on behalf of the Medical Information Working Group, a coalition of thirteen drug and device manufacturers that Ropes & Gray co-represents—that FDA hadn’t given sufficient deference to the growing body of case law indicating that product manufacturers have a First Amendment right to communicate truthful and non-misleading information to health care professionals and payers.  I also said at the hearing that to facilitate informed decision-making and to enhance patient care, FDA must ensure that there are clearly defined and effective pathways for manufacturers to communicate about their products in a responsible way—even if that information does not appear in FDA-approved labeling.  Many other speakers at the hearing, including representatives from industry, the medical profession, payers, and patient groups—also took FDA to task, arguing that the agency’s restrictive policies violated the First Amendment and interfered with good patient care.

Even though the November public hearing was about off-label communications, FDA did not go on the record there to justify its regulatory framework as consistent with the Constitution.  The recent First Amendment memo was the agency’s attempt to do just that.  The memo recited the exact same arguments against off-label communications that we’ve been hearing now for decades, emphasizing the “parade of horribles” that could result if manufacturers had free reign to engage in false or misleading off-label promotion, and painting industry as a bad actor motivated largely by economic interests.  Of course, no one in industry is advocating for the right to share false or misleading information about off-label uses.  That information isn’t even protected by the First Amendment.  And in many cases, manufacturers are the best or only source of information about off-label uses for their products, so it is absolutely critical that there be clear and effective avenues for them to share it—especially to counteract the often outdated and inaccurate information that doctors and patients may find from other sources online.  Yet the First Amendment memo doesn’t pay significant attention to those points, choosing instead to defend the status quo.

Though FDA largely stuck to its guns in the First Amendment memo, it did issue two draft guidance documents  in the last days of the Obama administration that provide some flexibilities for manufacturers to share information not found within the four corners of the product label.  First, FDA issued draft guidance on communications with payers.  The agency had never issued guidance on this topic despite repeated industry requests, so this document does provide some welcome clarity in a space where FDA had never weighed in.  The guidance on the whole is pretty reasonable and in many ways validates what industry had been doing for a long time; that said, the guidance is far from perfect, and some of the recommendations offered by FDA are unclear or may be unworkable in practice.  The second draft guidance document relates to communications that are “consistent with the labeling”—here, too, the guidance is welcome. The guidance is a bit of a mixed bag, though, because even though it gives manufacturers some flexibility, it’s still pretty narrow and leaves many questions unanswered.  Taken together, the First Amendment memo and the two guidance documents indicate that the outgoing leadership at FDA may have been willing to give some ground at the edges, but were nowhere near ready to tackle the First Amendment issues head-on.