On March 20, 2017, FDA announced a further delay of the effective date of its January 9, 2017, Final Rule entitled Clarification of When Products Made or Derived From Tobacco Are Regulated As Drugs, Devices or Combination Products; Amendments to Regulations Regarding “Intended Uses,” and requested comments on the industry petition filed in February requesting a stay and reconsideration of the Final Rule. 82 Fed. Reg. 14319; 82 Fed. Reg. 2193. The effective date of the Final Rule had already been delayed once by the incoming Administration. As a result of this most recent announcement, the expansive interpretation of intended use proposed by FDA will not be enforceable until at least March 19, 2018, although the controversial accompanying preamble language could be invoked now, including in False Claims Act (FCA) cases based on alleged violations of the Federal Food, Drug, and Cosmetic Act (FDCA).
On March 8, 2016, Amarin Pharma, Inc., advised Judge Paul Engelmayer of the United States District Court for the Southern District of New York that the company had reached agreement with the Government on the resolution of the parties’ dispute over Amarin’s entitlement to engage in certain types of communication to physicians regarding the health benefits of the company’s drug, VASCEPA. Judge Engelmayer signed the proposed stipulation and order later that day.
The settlement is noteworthy for the obvious reason that it continues the Government’s string of losses in First Amendment cases involving the Federal Food, Drug, and Cosmetic Act. But it also matters because it entitles Amarin to use a special advisory comment process for off-label materials, and did not condition resolution of the litigation on Amarin’s agreement to vacate the court’s powerful August opinion finding the FDA’s rejection of Amarin’s proposed claims unconstitutional. It is also important, however, because it appears to qualify Amarin’s victory somewhat, by holding the company accountable for the continued accuracy of its claims and permitting the Government to proceed against Amarin based on shifts in the science supporting those claims.
On August 7, in the first Caronia progeny case, the United States District Court for the Southern District of New York (Engelmayer, J.) granted preliminary relief to Amarin Pharma, Inc. (“Amarin”) in a highly significant case involving First Amendment limitations on the Government’s entitlement to bring misbranding charges based on manufacturers’ truthful, non-misleading speech about off-label uses of drugs. See Amarin Pharma Inc. v. Food and Drug Admin., No. 1:15-cv-03588 (S.D.N.Y. Aug. 7, 2015).
On June 6, 2014, FDA sent a letter to counsel for the Medical Information Working Group (MIWG), a coalition of biopharmaceutical and medical technology developers advocating that the Agency clarify its policies on manufacturer dissemination of scientific and medical information and conform those policies more faithfully to constitutional and statutory limitations. The June 6 letter represents a promising development. For one thing, it shows that FDA recognizes the importance of wrestling with recent developments in the case law, including Sorrell, Fox II, and Caronia, which recognize that the First and Fifth Amendments provide a high level of protection for manufacturer speech about medical products. It’s also encouraging to see agency officials both beginning to articulate a rationale for FDA’s approach to speech regulation and putting recent policy developments, such as the recently reissued reprints guidance, into the broader context of a “comprehensive review of . . . regulations and guidance documents.” Such a review is sorely needed.
But FDA’s response to the petition, on balance, is far from encouraging. It doesn’t take much examination of the Agency’s June 6 letter to find a number of reasons to remain skeptical that FDA truly “gets it” (or, if the Agency “gets it,” is willing to “act on it”) when it comes to speech regulation. Below are five such reasons:
1. FDA advances the same rationale for the current regulatory framework that the Agency has provided in defense of First Amendment critiques for many years. The letter describes FDA’s regulation of manufacturer speech as incidental to the Agency’s administration of statutory provisions that have been refined over time to protect the public health. It cites the same historical events—from “Elixir Sulfanilamide” to thalidomide and the Dalkon Shield to ecainide/flecainide—on which FDA has relied for years to justify its expansive approach to regulating manufacturer speech, even about products that have already been through the demanding premarket review process and the speech is accurate. The June 6 letter does not acknowledge the changes in the legal environment, patient expectations, and the healthcare delivery system that call into question the relevance of these old examples.
2. FDA says that its goal in considering the MIWG’s petition is “to harmonize . . . protecting the public health with First Amendment interests.” The First and Fifth Amendment principles recognized and applied by the Court in Sorrell and Fox II do not yield, even to an extraordinarily compelling government interests. Under even the relatively flexible Central Hudson algorithm, a substantial regulatory justification does no more than to enable speech regulation to survive to a subsequent stage of judicial scrutiny. If recent decisions have proven anything, it’s that these constitutional “interests” are not especially amenable to balancing. FDA ignores the heightened scrutiny to which the courts will subject the Agency’s approach at its peril.
3. FDA asserts a broad “intended use” interpretation that does not accord with the totality of the case law and continues to represent the most significant source of unpredictability and dislocation in the current enforcement climate. The response, in a footnote, cites a 1980 D. C. Circuit decision that includes language (“any other relevant source”) on which FDA and the Department of Justice have relied to assert that a broad range of evidence, including internal company documents, can be used against manufacturers in FDCA misbranding actions. If FDA were serious about aligning the regulatory and enforcement framework with statutory limitations, then the June 6 response would not have included this citation.
4. FDA defends its continued reliance on guidance documents to regulate in an area that demands the clarity that notice-and-comment rulemaking provides. Responding to the MIWG’s request for binding regulations rather than guidance, the June 6 letter states that it is FDA’s “judgment that issuing guidance initially to address industry questions is an effective first step” that does not “preclud[e] . . . new or modified regulations.” Despite that assertion, FDA does not issue guidance as an “initial” way of addressing industry questions before regulations are issued. It uses guidance to regulate — and often does not finalize guidance documents at all. Given the processes that FDA uses to generate guidance, and its tendency to leave guidances in draft form as de facto binding legal norms, it is almost certain that FDA will end up making the regulatory climate more ambiguous unless external forces (such as continued congressional oversight, further litigation, and sustained industry engagement) lead to a change in course.
5. FDA’s approach to day-to-day oversight of manufacturer communications has not changed. FDA says that it is granting the MIWG’s request for a review and promises to take certain actions, including issuing guidance before the end of the year. In the meantime, however, it appears nothing has changed. The Office of Prescription Drug Promotion (OPDP), which has primary responsibility for administrative implementation and regulatory enforcement of the FDCA, continues to send warning and untitled letters to manufacturers based on legal theories that would not withstand judicial scrutiny. OPDP also uses the non-public advisory comment process, which is designed to provide manufacturers with a means of obtaining prompt, binding advice on proposed promotional materials, to chill manufacturer speech in two ways—by needlessly dragging the process out for months, and by taking uninformed, punishingly limited positions on the substance of what manufacturers can say. it is hard to take seriously any assertion that FDA cares about honoring legal limitations given OPDP’s “business as usual” stance, to say nothing of the ways in which OPDP’s recent guidance pronouncements have actually made matters worse.
Perhaps agency officials believe, as the Caronia dissent says, that the First Amendment represents an existential threat to FDA’s historical approach to drug and medical device regulation. But the research-based, innovative developers of new therapies have more at stake in preserving the core elements of the regulatory system—especially a high standard for efficacy in the NDA and PMA contexts—than even FDA. The real danger to FDA’s regulatory authority is from other stakeholders, who are considering and will inevitably commence litigation. It is a virtual certainty that such disputes will lead to further judicial decisions that would implicate FDA’s authority in ways far more profound than the MIWG has advocated.
To be sure, continued indiscriminate investigations under the False Claims Act by DOJ and actions by the increasingly aggressive relators bar require manufacturers to assert First Amendment and other constitutional defenses. Industry would much prefer a rational enforcement landscape than a system that makes such defenses necessary.
The most encouraging sign that FDA will change its regulatory ways—one hopes, with DOJ not far behind—is not the June 6 response to the MIWG’s petition. It’s the comments from Janet Woodcock, Director of FDA’s Center for Drug Evaluation and Research, at the Food and Drug Law Institute annual conference in April. Dr. Woodcock recognized not only the recent judicial decisions reflecting manufacturer’s entitlement to clarity and to adequate room in the regulatory scheme to provide scientific and medical information about their products, but also what are perhaps the two most important sources of pressure on FDA’s institutional commitment to business as usual: changing societal expectations, particularly patient demands for greater involvement in their own healthcare, and the profound ways in which the healthcare delivery system itself has changed.
Ultimately, the degree to which the FDA regulatory system, and the accompanying—by now extraordinarily dysfunctional—enforcement scheme, will yield to manufacturers’ requests for clarity and alignment with First and Fifth Amendment values will depend not on lawyers’ arguments and judicial decisions, but rather on the legitimate and increasingly forceful demands of a much changed world.
MIWG is represented by Sidley Austin and Ropes & Gray. However, the views expressed here are the author’s alone and do not necessarily represent the position of any Firm client.