This summer, in a letter to counsel, the Food and Drug Administration (FDA) granted citizen petitions that asked the agency to clarify its regulations and policies regarding truthful, non-misleading scientific communications and activities related to investigational new drugs and devices, reports Health Reform Watch. In particular, as part of a general commitment to “engage in a comprehensive review of the regulatory regime governing communications about medical products,” FDA agreed to provide greater regulatory clarity in the areas of manufacturer responses to unsolicited requests; scientific exchange; interactions with formulary committees, payors, and similar entities; and dissemination of third-party clinical practice guidelines.
Background: Medical Information Working Group (MIWG)
Last year, the Coalition for Healthcare Communication noted that MIWG—a coalition of medical product manufacturers seeking to improve the regulatory and enforcement environment for communications about new uses for approved or cleared products—asked the FDA Center for Drug Evaluation and Research’s (CDER’s) Medical Policy Council to take “immediate action … to assure that manufacturers are permitted to provide truthful and non-misleading information to support clinical and economic decision making and protect and promote the public health.”
“Manufacturers have the most information about their products, so it makes a lot of sense that they should be able to communicate their data so the most prudent public health decisions can be made,” said Coalition for Healthcare Communication Executive Director John Kamp. “As the reimbursement climate changes, it is important that payers have the most accurate, up-to-date information and that manufacturers can provide it to them without fear of FDA enforcement action,” Kamp remarked.
In July 16 comments to the agency, the MIWG is following up on multiple documents it has sent to the FDA since 2008 regarding this and similar issues. In addition to its recent comments, the MIWG also filed a citizen petition Sept. 3, asking the FDA to complete the process of responding to its first citizen petition submitted in July 2011, and requesting that the agency review the recent developments in First and Fifth Amendment case law, as well as ongoing changes in the delivery of medical services, according to Alan Bennett, Partner, Ropes & Gray, counsel to the MIWG.
“Manufacturers have felt a great need for clarity for some time,” Bennett told the Coalition. “It’s hard to run a business when the rules are not clear. The result is a lot of self-censorship that is probably not beneficial for patient care. Clarity would be helpful.”
FDA Letter
On June 6, the FDA responded to the citizen petitions that asked the agency to clarify its regulations and policies regarding truthful, non-misleading scientific communications and activities related to investigational new drugs and devices.
Specifically, FDA agreed to provide greater regulatory clarity in four specific areas:
- (1) Manufacturer responses to unsolicited requests;
- (2) Scientific exchange;
- (3) Interactions with formulary committees, payors, and similar entities; and
- (4) Dissemination of third-party clinical practice guidelines.
However, the majority of FDA’s letter simply walks through the regulatory framework created by the Federal Food, Drug, and Cosmetic Act FDA also went over its previous guidance in this arena. In December 2011, the agency issued a draft guidance, “Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices.” In February 2014, the agency released a revised draft guidance, “Distributing Scientific and Medical Publications on Unapproved New Uses — Recommended Practices,” which proposes to revise the agency’s 2009 Good Reprint Practices Guidance.
Furthermore, at the same time that it granted the citizens petitions, FDA also issued “Draft Guidance for Industry on Distributing Scientific and Medical Publications on Risk Information for Approved Prescription Drugs and Biological Products–Recommended Practices,” which addresses the dissemination of risk information for approved prescription drugs and biological products.
While FDA retreaded a lot of old ground, the agency stated that its goal is to harmonize its “fundamental interest” in protecting public health with “First Amendment interests in the dissemination of truthful, accurate, and non-misleading information regarding medical products.”
Promising Development
Sidley Austin’s False Claims Act blog writes that the June 6 letter represents a promising development. They note: 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.
Concerns Still Remain
However, the False Claims Act blog also notes the FDA’s response to the petition, on balance, was far from encouraging. They are skeptical that the FDA truly “gets it” when it comes to speech regulation and lists the following five 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 health care 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
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.
Conclusion
The False Claims Act blog concludes: 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.