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DELAYED: The FDA’s Intended Use Rule

Written by Michael A. Walsh on March 21, 2017

The effective date of FDA’s Intended Use Rule has been extended until March 19, 2018.  The comment period will remain open until May 19, 2017.

The FDA is delaying the effective date to invite public comment on substantive issues raised in a Citizen’s Petition.  The Petition was filed on behalf of the Medical Information Working Group (MIWG), a consortium on manufacturers that has been at the vanguard of Due Process and First Amendment issues.  The Petition addresses the decade’s long problematic last sentence of 21 C.F.R. § 201.128 (for drugs) and 21 C.F.R. § 801.4 (for medical devices) which each state:

And if the totality of the evidence establishes that a manufacturer objectively intends that a device introduced into interstate commerce by him is to be used for conditions, purposes, or uses other than ones for which it has been approved, cleared, granted marketing authorization, or is exempt from premarket notification requirements (if any), he is required, in accordance with section 502(f) of the Federal Food, Drug, and Cosmetic Act, or, as applicable, duly promulgated regulations exempting the device from the requirements of section 502(f)(1), to provide for such device adequate labeling that accords with such other intended uses.

This language in the new rule, as with the prior version, suggests that knowledge of actual use of a medical product creates an obligation to “provide adequate labeling” concerning such use.  Notwithstanding this language, court rulings rejected the notion and the FDA itself has stated that it “usually” does not rely on a manufacturer’s knowledge to infer an intended use.

In fact, in its proposed draft intended use rule, the FDA struck the final sentence from both rules. However, the Final Rules did not delete the final sentences but instead replaced them with a new – equally perplexing – “totality of the evidence” standard.

In its Final Rule, FDA claimed the proposed rule sought to clarify that knowledge of an actual use did not “automatically trigger obligations for the manufacturer to provide labeling,” but also did not intend that “knowledge” of such use would be “eliminate[d]… altogether as a source of evidence of intended use.”  According to FDA, its goals would “be better achieved by amending the last sentence of each regulation rather than deleting them”.

The Petition challenged the Final Rule as violating the fair notice requirements under the Administrative Procedures Act, chilling scientific exchange and for introducing a new and constitutionally flawed we-know-it-when-we-see it “totality of the evidence” standard.  The concern with this new standard is that it will only further encourage reliance on vague misbranding arguments by prosecutors and private claimants.

In its Notice extending the enforcement deadline, FDA stated that it was merely attempting to reiterate its “longstanding position” that “FDA would not regard a firm as intending an unapproved new use for an approved or cleared drug or device based solely on that firm’s knowledge that its product was being prescribed or used by doctors for such use.”

The FDA’s concern is that determining intended use requires “consideration of evidence such as the circumstances surrounding the distribution of a product, the known effects of a product or substance, and/or the context in which the product is sold in order that firms that attempt to evade FDA’s medical product regulation by making no claims, or at least no explicit claims, about their products can be held accountable.”

The FDA lists four specific questions on which it is soliciting comments:

  • How should FDA consider situations such as those outlined above where companies and individuals distribute medical products and/or seek to import medical products without explicit promotional claims?
  • What are the potential public health consequences, positive and negative, that should be considered in evaluating whether to adopt any of petitioners’ suggested approaches to determining intended use?  What other policy considerations are relevant when assessing approaches to intended use?
  • To the extent First Amendment considerations apply as the legal rationale, how do those considerations apply to the use of non-speech evidence in determining intended use, such as the circumstances surrounding the distribution of a product or the context in which it is sold? Is there is a distinction between considering ‘‘any relevant source of evidence’’ and ‘‘the totality of evidence?”
  • Is there is a distinction between considering ‘‘any relevant source of evidence’’ and ‘‘the totality of evidence’’? What wording provides the most clarity to regulated entities?

In addition to the Rule on Intended Uses, which has been difficult for industry for decades, FDA is wrestling with a related docket on “Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products.”

At the core of both of these issues is whether the U.S. Constitution provides flexibility to allow FDA to craft vague rules that it can apply using its regulatory expertise to balance Due Process and First Amendment concerns.  This balance had been left in the hands of the administrative agencies, for many decades, but the legal, scientific, medical and social environment has changed radically.

Today, the Supreme Court does not defer to the judgment of the administrative branch nearly as readily as in the past.  Science and medicine are aided by advances in technology and communications, and consumers are far more capable of locating information and educating themselves. Perhaps more significantly, the Supreme Court itself has only recently looked closely at whether and to what extent manufacturers of FDA regulated products are entitled to Due Process and First Amendment protections in the sale and distribution of their products.

Many aspects of the law on this subject are evolving and unsettled, such as the notion of commercial speech itself which remains undefined by the Supreme Court. The issues of Due Process and the First Amendment are challenging enough for the Supreme Court, but to expect the regulators at the FDA to craft a set of guidelines that navigates Due Process and the First Amendment is asking too much of an FDA entrenched in its decades old policy approach to these issues.

Industry needs a set of clear rules, requirements and guidelines that allows for the free flow of medical and scientific information.  This free flow of information leads to medical and scientific advances, improves lives and gives hope.  Industry can be expected to negotiate because it benefits from a clear and uniform national scheme that preempts state and common law action.  FDA can be expected to finally change its intractable position because the courts are no longer supporting its “speech is conduct that is evidence of intent” argument.

However, no rule or guidance will be issued that cannot be challenged on constitutional grounds, and any rule on this issue is certain to find a detractor.  What is long overdue is for Congress to wrestle with the constitutional underpinning of this issue and, in exchange for preempting state and common law claims, to demand a lot from both industry and the FDA.