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Bexis recently gave the keynote address at the Minnesota State Bar Association’s annual FDA Forum.  In preparing his speech, which concerned recent challenges to FDA regulatory authority, Bexis had occasion to study Apter v. Dep’t of HHS, 80 F.4th 579 (5th Cir. 2023), which the blog previously discussed here. Since Bexis was discussing a variety of existing or threatened disputes over the FDA’s power, he simultaneously took a fresh look at the FDA’s pending draft guidance, Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers.  Bexis had previously discussed this draft guidance almost solely from the vantage point of the First Amendment. That post pointed out the numerous constitutionally questionable content-based and speaker-based restrictions that the draft (while allowing more types of off-label speech than before) created to hem in such speech.

Apter suggests another response to the FDA’s pending draft guidance.  To recapitulate Apter, that decision involved FDA statements, made during the COVID-19 pandemic, concerning the safety of the approved anti-parasitic drug ivermectin for off-label treatment and prevention of COVID − statements that ran the gamut from rather flippant social media posts to a full-blown “Consumer Update.” 80 F.3d at 584-85.  The Apter plaintiffs were doctors using the human, not equine, version of ivermectin for off-label COVID-19 treatment.  Id. at 585.  They claimed that the FDA’s statements caused them to lose patients that they otherwise would have profitably, if not necessarily successfully, treated, as well as damage to their medical reputations.  Id.

In an unusual move, they sued the FDA directly.  Predictably, the agency claimed sovereign immunity − but lost.  Id. at 858-86.  Plaintiffs defeated sovereign immunity with a claim that, in warning the public against the risks of off-label use of ivermectin, the FDA had acted beyond its statutory authority – ultra vires − because, as we have frequently pointed out over the years, the FDA has no authority to regulate the practice of medicine.  Here’s how Apter put it:

[Plaintiffs] can use the APA to assert their ultra vires claims against the defendants.  FDA can inform, but it has identified no authority allowing it to recommend consumers “stop” taking medicine.  [Plaintiffs] can therefore use the APA to assert their ultra vires challenge to the Officials’ actions, and to overcome the sovereign immunity that would otherwise protect the Agencies.

Id. at 587.  Why?  A section of the FDCA, 21 U.S.C. §396:

is titled “Practice of medicine,” and its plain text protects some aspects of the “practitioner-patient relationship” from FDA’s “limit[ation] or interfere[nce].”  As practitioners themselves, the [plaintiffs’] “interests” in the Act’s “purposes” are much more than “marginal[ ].”  Indeed, the Act expressly shields the Doctors from certain kinds of FDA meddling.

80 F.4th at 592.  Thus, “FDA is not a physician.  It has authority to inform, announce, and apprise − but not to endorse, denounce, or advise.”  80 F.4th at 595.  “[N]othing in the [FDCA’s] plain text authorizes FDA to issue medical advice or recommendations.”  Id. at 589.

As the Supreme Court stated in Buckman Co. v. Plaintiffs Legal Committee, “the FDA’s mission [is] to regulate in this area without directly interfering with the practice of medicine.”  531 U.S. 341, 350 (2001).  Bexis exhaustively addressed this proposition – for both drugs and medical devices – in his most recent law review article on off-label use.  See Beck, “Off-Label Use in the Twenty-First Century: Most Myths & Misconceptions Mitigated, 54 UIC J. Marshall L. Rev. 1, 14-28 (2021).  Cf. 42 U.S.C. §1395 (“Nothing in [the Medicare statute] shall be construed to authorize any Federal officer or employee to exercise any supervision or control over the practice of medicine.”).  While we think that Apter’s reliance solely on §396 is questionable, since that section is expressly limited to “the authority of a health care practitioner to prescribe or administer any legally marketed device” (emphasis added), the same principle applies to prescription drugs, and all the necessary prescription drug-related citations, both to FDA statements and judicial precedent, may be found in Bexis’ article.

We now turn back to the FDA’s pending off-label speech draft guidance, which as we pointed out before, deals with scientific speech, which has received core First Amendment protection for decades. The FDA’s draft calls such off-label speech “scientific information on unapproved use(s).”  But the draft guidance also impinges on the practice of medicine – directly and significantly.  The FDA is proposing to regulate information that the medical community as a whole receives about off-label uses.  Specifically, the FDA proposes to allow off-label speech that accurately reports on less than gold-standard, controlled and blinded studies.  But these other investigations must be “well-designed” and “well-documented.”  And they must originate with “qualified experts.”  All of which the FDA appears , we assume, will be decided by FDA, rather than the medical community.

Although, as per Apter and a great deal of other authority, the FDA has no authority over the practice of medicine, this draft guidance implicitly assumes that the agency somehow has the right to determine what constitutes “all information necessary” for medical professionals “to interpret strengths, weaknesses, validity, and utility” of off-label information.  The FDA would also determine what material is “relevant” to “clinical practice decisions,” and whether the source publications for off-label speech are “scientifically sound,” rather than leaving such decisions to the usual peer review process.  The draft also declares that all medical research discussed in off-label speech must be “scientifically sound, as well as “clinically relevant” to “individual patients.”  Allowable off-label speech also cannot involve “scientific data generated in early stages of product development,” which when it comes to severe, incurable conditions, might be of extreme interest to health care providers with no other good options to offer their patients.  Thus, in all of these ways (and more), FDA’s draft guidance proposes to take decisions about what information is important to medical practice away from the medical profession and give them instead to the Agency.

As we view it, the FDA’s imposition on medical practice in Apter was trivial compared to  what the agency’s 2023 draft guidance proposes to do.  Apter merely involved FDA criticism of one particular off-label use that the Agency believed, with good reason, posed safety risks to patients being treated in that fashion.  On the other hand, the draft guidance envisions FDA as the arbiter of not only off-label medical practice, but also of what doctors and other health care practitioners need to know in order to treat their patients.

Thus, with Apter the law of the Fifth Circuit, the First Amendment isn’t even necessary (although it would, in and of itself, be sufficient) to litigate a direct challenge to the FDA’s proposed “enforcement policy” for off-label speech.  Any challenge to FDA’s guidance can be mounted instead – or in addition – as nothing less than an ultra vires attempt by the FDA to seize control of the informational flow of the entire medical profession as it pertains to their right to practice medicine through off-label use.  All the industry (either drug or device manufacturers, or both) need do is file suite somewhere in the Fifth Circuit, and they sue the FDA directly, as in Apter, and even seek a damages remedy.  If what FDA did in Apter is ultra vires, then its lack of authority to restrict truthful off-label speech from the entire medical profession should be a fortiori.