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In addition to its recent revamp of its “§510(k)” substantial equivalence clearance process for medical devices, (see our post here), the FDA has also been active with respect to off-label communications – another regulatory area of continuing interest to this Blog.  Our position has been clear, and the same from the Blog’s beginning more than 15 years ago:  Truthful medically related speech from any source, including FDA-regulated product manufacturers, is First Amendment-protected scientific speech, and thus the FDA cannot constitutionally ban it by calling it “off-label promotion” (“promotion” not even being an FDCA-defined term).

The FDA, of course, has long thought otherwise, but as we have discussed in the above prior posts, it has been piling up losses on this issue over the last couple of decades.  E.g., Sorrell v. IMS Health Inc., 564 U.S. 552 (2011); Thompson v. Western States Medical Center, 535 U.S. 357 (2002); United States v. Caronia, 703 F.3d 149 (2d Cir. 2012); Amarin Pharma, Inc. v. FDA, 119 F. Supp.3d 196 (S.D.N.Y. 2015).

The FDA’s chief concern about off-label communications from manufacturers has less to do with the safety of such uses − many of which are medical standard of care and Medicare reimbursable − than with the agency’s own bureaucratic imperative.  The FDA is concerned, probably with reason, about its own power.  If unfettered truthful off-label promotion is permissible, then the incentives for regulated entities to spend the large amounts of time and money now required to submit new uses of already approved FDA-regulated products for additional approvals would be reduced.  Historically, the FDA has taken the easy way out and simply targeted truthful speech about even the safest off-label uses as “illegal”

Of course, the FDA could do that using non-speech-related means – making add-on approvals less onerous to obtain and/or imposing either dollar-amount or percentage-based requirements that require submission to the agency of off-label uses above certain thresholds.  Unfortunately, the FDA has been stuck in the rut of criminalizing speech for so long that hasn’t wanted to change unless courts forced it to.

But in its latest “revised draft guidance” on off-label speech, released last month and entitled:  “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers,” the FDA seems to be getting – slowly but surely – around to coming to grips the legality of truthful off-label speech.

First, terminology.  What the FDA calls, rather ponderously, “unapproved uses of approved/cleared medical products,” everybody else in the world (including the Supreme Court in Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001)), calls “off-label use,” so we go with the majority naming convention.  However, the FDA’s new Draft Guidance introduces another phrase, “scientific information on unapproved use(s)” (“SIUU”), that at least has a decent acronym, so we will use that.

We’re viewing the FDA’s action solely from a First Amendment/product liability litigation standpoint, so to us, the most significant change is the agency’s expansion of legal communications.  First, such communications may now be directed to any health care provider – not just health insurers seeking to determine whether an off-label use should be covered, as was previously the case.  Now:

The term health care providers (HCPs) refers to individuals such as physicians, veterinarians, dentists, physician assistants, nurse practitioners, pharmacists, or registered nurses who are licensed or otherwise authorized by law to prescribe, order, administer, or use medical products in a professional capacity.  The recommendations in this guidance are specific to communications by firms to HCPs engaged in making clinical practice decisions for the care of an individual patient.

Draft Guidance at 6.  So one major advance is that off-label communications, assuming they meet the FDA’s substantive standards, may be directed essentially to any treater who might find them useful.

Another example of the Draft Guidance embracing more truthful off-label speech is the scope of permissible communications.  The FDA is no longer limiting permissible off-label communications to the results of expensive and lengthy randomized and controlled studies.  Beyond such gold-plated research:

[O]ther well-designed and well-conducted trials are also able to generate scientifically sound and clinically relevant information. . . .  [These] may include well-controlled investigations, partially controlled studies, studies and objective trials without matched controls, well-documented case histories conducted by qualified experts, and reports of significant human experience with a marketed device.

Id. at 10.  Moreover, the FDA finally recognizes that “[r]eal-world data and associated real-world evidence about medical products may be scientifically sound and clinically relevant.”  Id.

Thus, off-label communications to “health care providers” (no longer limited to health insurers) may discuss all types the FDA calls “[p]ublished clinical reference resources.”  See Id. at 20-26 (going into great detail about what such “references” may, or may not, contain).  This SIUU includes a much broader universe of materials – essentially any medical literature, provided that it is not “false, misleading, biased, or not based on studies and analyses that are scientifically sound and able to provide clinically relevant information.”  Id. at 9.

[T]he studies or analyses . . . should meet generally accepted  design and other methodological standards for the particular type of study or analysis performed, taking into account established scientific principles and existing scientific knowledge.

Id. at 10.  That’s a significant step forward, since it aligns the FDA’s view of permissible science more closely to what doctors (and Medicare) actually rely on in clinical situations.  We agree that material that “lack[s] enough detail to permit scientific evaluation” would generally not be scientifically sound.  Id. at 11.  Likewise, “communications that distort studies as well as communications based on publications that distort studies or include fraudulent data,” id., have no business being disseminated by anyone.  We’ve been fighting against similar junk science in litigation for many years.

As one would expect, the FDA requires a variety of disclosures and disclaimers – more than a dozen of them.  Id. at *12-13.  We won’t go into detail because we’re interested in the First Amendment and litigation aspects of this FDA’s relaxed restrictions, not its regulatory implications.  These details should not give rise to “parallel” claims, as they arise from FDA regulatory requirements, not the common law.  For instance, we’re not aware of any common-law requirement that promotional materials include “the most current FDA-required labeling,” to take one example.  Id. at 13.  Another long overdue FDA relaxation of restrictions on truthful off-label communications is that SIUU distributed by manufacturers may include “both audio and visual components.”  Id. at 15.  Off-label communications are no longer limited to the printed word.

Still off-limits, however, are so-called “persuasive marketing techniques” for off-label uses.

[T]hese marketing techniques influence use of the products based on elements other than the scientific content of the communication (as used herein, “persuasive marketing techniques”).  Examples of these persuasive marketing techniques include the use of celebrity endorsements, premium offers, and gifts.

Id. at 15 (footnote omitted).  We’re agnostic about these, but as the FDA points out such techniques aren’t based on science, and thus for First Amendment purposes would not fall within the category of protected scientific speech.

In another free speech advance, online off-label communications are now specifically allowable, subject to relatively minor restrictions to maintain separation between scientific off-label information and permissible promotion of on-label uses:

[F]irms may be interested in sharing information about both the approved and unapproved uses of their medical products online through websites. In these cases, FDA recommends that SIUU communications be on a separate web page from the web page that hosts promotional communications about the approved uses of the medical product.  FDA also recommends that firms not include direct links from web pages that host promotional communications about approved uses to webpages that host SIUU communications.  Similarly, FDA recommends that email messages used to share SIUU communications be separate and distinct from email messages used to share promotional communications about approved uses of the medical product.

Id. at 18.  Even “character-space limited platforms” may play a role, if only “to direct HCPs to an SIUU communication through a statement that does not mention the name of any specific medical product.”  Id. at 19.

In the past, we’ve been quite critical of the FDA for its unwillingness to grapple with the simple fact that truthful scientific speech – and thus First Amendment protection − can extend to off-label uses.  This Draft Guidance, however, seems to be different.  Were it to go into effect without being watered down, this regulatory regime could stand a prayer of being upheld against the most common First Amendment challenges that we’ve seen (and advocated) in the “off-label promotion” context.  Finally, the FDA seems on course to bring its off-label promotion restrictions into a closer relationship with the truth, and thus with the First Amendment.