FAN 70.1 (First Amendment News) Amarin v. FDA –Important Commercial Speech Case May be Decided Soon

The FDA has long sought to ban manufacturers from promoting off-label uses of approved drugs and medical devices.  In taking the position that manufacturers and their agents cannot promote off-label uses, the FDA suggests they are safeguarding the public from misbranded medical products and ensuring that manufacturers do not circumvent the drug and device approval processes. Critics, however, have long contended that the FDA’s position violates the First Amendment to the extent it prohibits truthful speech. — Evelien Verpeet, ReedSmith, June 18, 2015

Should pharmaceutical companies be able to advertise drugs for uses not  approved by the FDA? It seems like a no brainer — of course not! But as with so many other things in life and law, the answer (especially the First Amendment answer) is not so obvious.

→ The caseAmarin Pharma, Inc. v. United States Food & Drug Administration (Dist. Ct., S. Dist. NY).

→ Judge: The matter was argued before U.S. District Judge Paul A. Engelmayer on July 7, 2015. A ruling is expected soon.

Unknown5→ Plaintiff’s Claim: “Amarin Pharma wants to provide healthcare professionals with truthful, non-misleading information about its prescription drug Vascepa®, and four doctors who want to receive that information, as they determine when and whether to prescribe that drug. If Amarin provides that information, however, it is at high risk of criminal and civil sanctions being sought against it by the United States.”

U.S. Atty. Preet Bharara

U.S. Atty. Preet Bharara

→ Government’s Claim: “Plaintiffs seek a court order that would allow Amarin to distribute its drug Vascepa under circumstances which could establish that Amarin intends an unapproved new use for Vascepa, i.e., a use for which FDA has not determined that the drug is safe and effective. But Plaintiffs’ legal arguments strike at the very heart of the new drug approval process, and a court decision in Plaintiffs’ favor has the potential to establish precedent that would return the country to the pre-1962 era when companies were not required to prove that their drugs were safe and effective for each of their intended uses.”

The FDA has long banned promotion of drugs for uses other than those it has approved. Yet so-called off-label uses are legal and account for about 20% of all prescriptions. Some off-label uses of drugs have even become the standard of care for particular conditions. But the drug’s manufacturer and its agents—and only them—cannot legally talk about this. Patients can—and do—discuss off-label uses of drugs endlessly in online forums. Doctors certainly exchange information about these uses. — David B. Rivkin Jr. &  Andrew Grossman, WSJ, May 21, 2015

 P’s Counsel: Floyd Abrams is the lead counsel for the Plaintiff with Joel Kurtzberg and Michael B. Weiss (see here re P’s complaint)

→ Gov.’s CounselPreet Bharara is the attorney for the Defendant along with Ellen London and Benjamin Mizer

→ Amicus Briefs: Pharmaceutical Research and Manufacturers of America and Washington Legal Foundation — both in support of the Plaintiff / Public Citizen in support of the United States

→ FDA Letter to Judge Engelmayer, June 8, 2015 (see here for a discussion of the mootness issue raised by this letter)

Excerpts from United States v. Caronia (2nd Cir. 2012) re off-label promotions 

The government’s construction of the FDCA asprohibiting off-label promotion does not, by itself, withstand scrutiny under Central Hudson’s third prong [that the regulation directly advance the government’s interests] . . . . The last prong of Central Hudson requires thegovernment’s regulation to be narrowly drawn to further the interests served. . . Here, the government’s construction of the FDCA to impose a complete and criminal ban on off-label promotion by pharmaceutical manufacturers is more extensive than necessary to achieve the government’s substantial interests. . . . We conclude simply that the government cannot prosecute pharmaceutical manufacturers and their representatives under the FDCA for speech promoting the lawful, off-label use of an FDA-approved drug. Judge Denny Chin for the majority.

* * * *

[T]he majority calls into question the very foundations of our century-old system of drug regulation. I do not believe that the Supreme Court’s precedents compel such a result. . . . If drug manufacturers were allowed to promote FDA-approved drugs for non-approved uses, they would have little incentive to seek FDA approval for those uses. — Judge Debra Ann Livingston dissenting

Summary of Amarin’s First Amendment Arguments

Floyd Abrams

Floyd Abrams

Plaintiffs are Substantially Likely to Succeed On The Merits

    FDA’s off-label promotion ban violates Plaintiffs’ First Amendment rights:

  1. Off-label promotion is protected speech (“'[S]peech in aid of pharmaceutical marketing,’ the Supreme Court has stated, “is a form of expression protected by the Free Speech clause of the First Amendment.” Sorrell v. IMS Health Inc., 131 Sup. Ct. 2653, 2659 (2011). . . .  In what has been described as a “watershed decision,” Caronia held that under the First Amendment the government may not prohibit or punish “speech promoting the lawful, off-label use of an FDA-approved drug.”)
  2. Amarin’s proposed speech is protected under the First Amendment (“Caronia establishes that Amarin is substantially likely to succeed on the merits of its First Amendment challenge to the FDA regulations Caronia held were subject to heightened scrutiny. As to prong one of Central Hudson, Caronia established that off-label promotion concerns lawful activity and is not inherently “in and of itself false or misleading.” The speech Amarin proposes to engage in . . . consists of carefully- circumscribed, truthful, and non-misleading statements.”)
  3. FDA regulations improperly burden Doctor Plaintiffs’ First Amendment rights (“The First Amendment protects the right to receive commercial speech. See Sorrell, 131 S. Ct. at 2664 (‘A consumer’s concern for the free flow of commercial speech often may be far keener than his concern for urgent political dialogue.’) FDA’s off-label promotion ban infringes the Doctor Plaintiffs’ First Amendment rights because they cannot receive truthful and non-misleading information about the risks and benefits of Vascepa® to make fully-informed medical decisions for their patients. Such information is essential to doctors.”)

See here re Gov.’s brief in response.

Summary of Government’s Arguments

[see here re full memo in opposition]

Amarin’s Proposed Speech Is Not Unconstitutionally Infringed

  1. The First Amendment Allows the Government to Rely on Amarin’s Dissemination of the Communications at Issue as Evidence of Intended Use
  2. The First Amendment Allows the Government to Prohibit Any False or Misleading Statement About Vascepa
  3. The Challenged FDCA Provisions Meet First Amendment Standards for Regulation of Commercial Speech As Applied to Amarina

a.  The Requirement That Drugs Be Safe and Effective for Each of Their Intended Uses Directly Advances  Substantial Public Health Interests

b.  The FDCA as Applied to Vascepa is Narrowly Drawn and Not More Excessive Than Necessary; Any Alternative Would Be Ineffective or Impractical

i.  Plaintiffs’ Proposed Reliance on Disclaimers by Drug Manufacturers Would Be Ineffective

ii.  Other Alternatives Including All Identified in Caronia Likewise Would Be Ineffective and Unfeasible and are Not Even Proposed by Plaintiffs.

→ See here re P.’s brief in response.

Will the Gov. Appeal if it Loses? 

In 2012 the Second Circuit Court of Appeals overturned—on First Amendment grounds—the conviction of a pharmaceutical sales rep for talking to physicians about the off-label uses of narcolepsy drug Xyrem. However, the agency has not appealed the decision in United States v. Caronia, most likely to avoid an adverse ruling by the Supreme Court that would apply across the country. 

Unfortunately, even if the government loses the Amarin case, it will again probably forgo an appeal. This would enable the FDA to continue enforcing a flagrantly unconstitutional policy by default. The best prospect for a cure may lie in Congress. — David B.Rivkin Jr. &  Andrew Grossman, WSJ, May 21, 2015

Panel Discussions: The First Amendment & Public Health

 March 27, 2015: University of Maryland Law School panel on: “First Amendment and Commercial Speech Relating to Health” (panelists: Jane Bambauer, Adam Candeub, Stephanie Greene, Kathleen Hoke, & Wendy Wagner) (YouTube video here)

Public Health in the Shadow of the First Amendment” — A Conference Hosted by Yale Law School, Yale Medical School, and the Yale School of Public Health, October 17, 2014 (YouTube videos  here & here)

Scholarly Articles

  1. Randall S. Stafford, “Regulating Off-Label Drug Use — Rethinking the Role of the FDA,” New Eng. J. Med., 1427 (2008)
  2. Joseph J. Leghorn et al., “The First Amendment and FDA Restrictions on Off-Label Uses: The Call for a New Approach,” 63 Food & Drug L.J. 391, 392 (2008)
  3. Michelle M. Mello, David M. Studdert & Troyen A. Brennan, “Shifting Terrain in the Regulation of Off-Label Promotion of Pharmaceuticals, 360 New Eng. J. Med.. 1557 (2009).
  4. Coleen Klasmeier & Martin H. Redish, “Off-Label Prescription Advertising, the FDA and the First Amendment: A Study in the Values of Commercial Speech Protection,” 37 Am. J.L. & Med. 315 (2011)
  5. Aaron S. Kesselheim, “Off-Label Drug Use and Promotion: Balancing Public Health Goals and Commercial Speech,” 37 Am. J.L. & Med.. 225  (2011)
  6. Marc J. Scheineson & Guillermo Cuevas, “United States v. Caronia: The Increasing Strength of Commercial Free Speech and Potential New Emphasis on Classifying off-Label Promotion as False and Misleading,” 68 Food & Drug L.J. 201 (2013)
  7. Case Note, “United States v. Caronia: Second Circuit Holds that Prohibiting Truthful Off-Label Promotion of FDA-Approved Drugs by Pharmaceutical Representatives Violates First Amendment,” 127 Harv. L. Rev. 795 (2013)
  8. Stephanie M. Greene vs Lars Noah, “Debate: Off-Label Drug Promotion and the First Amendment,” 162 U. PA. L. Rev. Online 239 (2014)
  9. Rodney A. Smolla, “Off-Label Drug Advertising and the First Amendment,” 50 Wake Forest L. Rev. 81 (Spring 2015)
  10. Christopher Robertson, “When Truth Cannot Be Presumed: The Regulation of Drug Promotion under an Expanding First Amendment,” Boston University Law Review (2014)

YouTube Posts

  1. Professor Richard Epstein

    Professor Richard Epstein

    Richard Epstein, “The FDA, Off Label Use, and the First Amendment,” Stanford Law School, Center for Law and Biosciences, January 15, 2013

  2. U.S. v. Caronia, One Year Later: The First Amendment and Federal Oversight of Off-Label Promotion,” Washington Legal Foundation,” January 16, 2014 (panelists: Coleen KlasmeierJonathan L. Diesenhaus  and Geoffrey Levitt)
  3. Alan Bennett, “Pharmaceutical Manufacturer Speech & Legal Developments,” YouTube, Oct. 17, 2011

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