United States: FDA's Off-Label Hearing Set For The Day After The 2016 Election

Last Updated: September 9 2016
Article by Michael A. Walsh

On September 1, 2016 the Food and Drug Administration (FDA) issued its Notice of Public Hearing on Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products (FDA's Off-Label Hearing). The FDA's Off-Label Hearing is scheduled for November 9-10, 2016, the Wednesday and Thursday immediately following the 2016 national election.

The FDA's Off-Label Hearing will begin the agency's Judgment of Solomon to decide where to draw the line between purported off-label promotion and the dissemination of truthful scientific and medical information. Off-label use is legal and is often recognized by the medical community and the FDA as the "standard of care." Yet data studying 725 million prescriptions showed that 20 percent were off-label and of those, 70 percent or over 100 million prescriptions were based on no science or weak science.1 On the other hand, the "promotion" of a product for an indication, dose or duration not in the FDA approved labeling is a "prohibited act" under the federal Food Drug and Cosmetic Act (FDCA) and is subject to civil and criminal enforcement.

This hearing is not the first FDA attempt at balancing the government's power to restrict speech by characterizing the dissemination of information by manufacturers as "promotion" or "promotional labeling." In 1996 and again in 2009, the FDA addressed manufacturer dissemination of information on the internet as its then "front burner" "high priority" issue and conducted multiple two day hearings, ultimately resulting in social media guidance being issued in 2014. Then, as now, Congress had left for the FDA the difficult task of navigating between allowing manufacturers to disseminate truthful scientific information and "promotional conduct.

Congress has provided little guidance to assist the FDA in threading the needle on regulating what a manufacturer can say about its products with the constraints of Due Process and the First Amendment. For the better part of the past decade, the FDA has been publically suggesting it will formulate a new set of rules balancing Due Process and the First Amendment. Earlier this year the FDA stated it would "[r]e-evaluate our regulation of drug advertising and promotion in light of current jurisprudence around the 1st Amendment" and placed the issue among its "Front Burner Priorities". The Off-Label Promotion Hearing is the FDA's important next step in the reevaluation process.

Most commentators agree that the 2016 election will have a significant impact on federal regulatory enforcement priorities and the FDA's Off-Label Promotion Hearing attendees will have little time to ponder the significance of the election results on the eight questions the FDA poses. The issues the FDA is seeking comment on include:

  1. What benefit is there to increased communications and how should it be done and monitored?
  2. What can be done to encourage supplemental applications for approval of the off-label or new use?
  3. What factors should manufacturers consider when disseminating off-label/new use information on the internet?
  4. What scientific and medical standards should apply to the information disseminated?
  5. How should the FDA assess "truthful and non-misleading" and are disclosures appropriate?
  6. What information from unpublished clinical studies should be made available?
  7. How should the FDA monitor the dissemination of new use information?
  8. What additional rules changes should the FDA consider?

For over 50 years, the FDA has justified constraining the free flow of product information by citing horrific instances from the past and the conduct of crooks, thieves and scoundrels who put harmful products in the marketplace with dreadful results. Nonetheless, constitutional considerations were given "back-burner" status and court challenges to the FDA's regime of enforcement have emerged only in fits and starts. The FDA's regulatory enforcement of off-label promotion began taking on water in earnest in 1998 in Washington Legal v Friedman. The Constitutional challenges to the scope of FDA oversight suffered another hit to the stern in 2002 in Thompson v Western States. But the early years of the century were a feeding frenzy for the FDA racking up billions of dollars in financial extractions from industry. Due Process and First Amendment defenses were no less potent then than they are today but manufacturers were rendered dumb in light of the ferocious threats of criminal and civil penalties that the government wielded. It wasn't until the State of Vermont went a step too far in Sorrell v IMS and the FDA started frying smaller fish that unexpected outcomes in seemingly insignificant cases moved the pendulum decidedly in favor of rejecting the approach the government had taken for decades.

The iceberg that hastened the sinking of the FDA's regulatory regime hit in 2012 in the landmark Second Circuit decision in US v. Caronia. Yet, despite that loss, the FDA continued rearranging the deck chairs until 2015 when the disastrous twins of Amarin and Pacira confirmed that the government is long overdue to revamp its regime governing the regulation of purported off-label communications. What Caronia, Amarin and Pacira now demonstrate is that the government's approach and severely punishing the free flow of truthful scientific and medical information suffers serious constitutional infirmities.

Beyond the constitutional issues, there is a moral imperative to provide more – not – less truthful scientific and medical information. The heart of the debate is the fact that no one has ever died or been injured because they had too much truthful scientific or medical information. But the opposite is certainly not true, and no one has been saved or cured by false or unreliable information.

This long overdue two-day Public Hearing will begin the contentious and challenging task of navigating Due Process and the First Amendment while placing significant restrictions on the free flow of information. After decades of denying the Constitution applies in the regulation, the FDA will need to listen closely.

History will likely forget that the FDA waited decades until the day after what is expected to be one of US history's most contentious elections, an election that will shape the Supreme Court for generations. What history may not forget or excuse is the continuance of a regulatory regime that throws the baby out with the bath water and restricts the free flow of truthful scientific and medical information.


1 See David C. Radley, Susan N. Finkelstein & Randall S. Stafford, Off-label Prescribing Among Office-Based Physicians, 166 Arch Intern Med 1021 (2006).

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Michael A. Walsh
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