A First Amendment Safe Harbor for Off-Label Promotion — The Right Course for the Government

It has been a busy month for legal commentators digesting the Second Circuit’s “landmark” decision in U.S. v. Caronia and its ramifications for the pharmaceutical industry. By ruling  2-1 that truthful, accurate and non-misleading off-label speech is constitutionally protected that cannot be used by the Government as the sole basis upon which to prosecute drug misbranding under 21 U.S.C. Section 331(a), the majority panel sent shock waves through the legal writing community.  While there has been no shortage of articles, alerts and commentary on the subject, few have addressed the only two important questions that remain in the aftermath of Court’s decision: First, will the opinion stand?  Second, if it does, can manufacturers actually begin to promote off-label?

In an article I recently wrote for Law 360, I stated that if the majority’s opinion stands, the inevitable outcome should be a guidance document from FDA that lays out the parameters of a true First Amendment “safe harbor,” i.e., one in which truthful, accurate and non-misleading off-label speech under certain circumstances will not be used as evidence in a misbranding prosecution.  However, the historical struggle between the First Amendment and the Government’s relentless efforts to maintain the upper hand in regulating pharmaceutical marketing would indicate that such an outcome, even if inevitable, is a long way off.

That Which Preceded Caronia

In the 1990′s the Washington Legal Foundation (WLF) filed a series of lawsuits against FDA’s restrictions on manufacturer dissemination of enduring materials (reprint articles and reference texts) and involvement in CME programs.  Following two district court opinions (WLF I and WLF III) holding that FDA’s rules violated manufacturers’ First Amendment rights and enjoining FDA from enforcing its enduring materials and CME guidances and FDAMA regulations (see e.g., Washington Legal Foundation v. Henney, 56 F. Supp. 81 (D.D.C. 1999)), the Government argued on appeal that the “Guidances” and regulations provided nothing more than “safe harbors,” ensuring that certain manufacturer acions would not be used against them in “misbranding” and “intended use” enforcement actions, and that nothing authorized FDA to prohibit or sanction speech.  By cleverly re-framing FDA’s policies as providing manufacturers with safe harbors, the Government essentially  took the constitutional issue off the table and prompted the D.C. Circuit Court to vacate the lower court’s injunctions.  Washington Legal Foundation v. Henney, 202 F.3d 331, 336-37 (D.C. Cir. 2000).  It would take another 10 years (and billions of dollars in criminal and civil penalties) later before the Government was forced to fend off another First Amendment challenge, this time from Allergan.  The thrust of Allergan’s suit was that FDA’s enforcement of the “intended use” regulation at 21 C.F.R. Section 201.128 and the “new drug” statute at 21 U.S.C. Section 355, created a “Catch 22″ that effectively prohibited manufacturers from speaking with physicians about off-label uses, even where such communications were essential for the safe and effective off-label use of the drug:  if a manufacturer knows that its drug is being used off-label and fails to provide adequate directions for the drug’s safe and effective use, it violates the intended use regulation; but, once the manufacturer provides adequate directions to avoid liability under the intended use regulation, it has introduced a “new drug” into interstate commerce, violating the new drug statute.  Although the Allergan case would have been an ideal vehicle for the federal courts to address the constitutionality of FDA’s clampdown on off-label speech, Allergan agreed to drop the suit as part of its $600 million settlement with the Government.

Caronia and the Future of Off-Label Promotion

Despite successfully dodging the First Amendment question in Henney and Allergan, the Government’s hand was forced once it pursued a criminal conviction against an individual who, unlike a publicly traded company, had nothing to lose in pressing the First Amendment argument.  The result was a narrow ruling that held for the first time that truthful off-label speech is protected under the First Amendment.  However, both the majority and dissent are in agreement on one important point:  the Feds have a substantial (maybe even compelling) interest in ensuring that manufacturers don’t evade the the FDA drug approval process and seek FDA approval for new indications.  Furthermore, as I noted in my last post, the majority didn’t reject the Government’s argument that it could use truthful off-label speech as evidence of intent to sell off-label — it merely held that such speech can’t be the only evidence of such intent — and offered no protection for off-label speech that isn’t truthful, accurate and non-misleading.  Although the majority’s assurances didn’t seem to offer the dissent any comfort – “I . . . fail to see how the majority’s reasoning would ever allow [off-label] speech to support a conviction  . . . ” — they raise the question of “what happens now”?

Assuming that the majority’s opinion stands in some form, will it change manufacturer behavior or the Government’s approach to off-label enforcement?  Let’s look at what just happened within the past week.  First, Par Pharmaceutical and the Government filed yet another stay with the D.C. District Court in their litigation over whether the First Amendment protects Par’s right to promote on-label in an off-label setting.  Although Caronia has almost certainly strengthened Par’s negotiating hand, if the parties settle, we may never learn how much the Government gave up as a result of the constitutional challenges.  Second, this week’s announcement that Amgen will be paying the Feds $762 million in criminal and civil penalties related at least in part to its off-label promotion of Aranesp (see United States v. Amgen, E.D.N.Y., Cr. No. 12-760) suggests that the Government may continue whenever it can to bully publicly traded companies into settling and paying big fines, which most will rather do rather than risk the possibility of real criminal charges that could put them out of business faster than they can shout “First Amendment!”

The Government could take the cynical approach and choose not to appeal Caronia and risk a worse ruling from the Supreme Court.  It could even rely on Caronia and argue that some fact it discovered in an investigation shows that a particular manufacturer’s sales rep’s speech wasn’t 100% truthful to justify criminal and civil sanctions — heck, even Caronia said things that could easily have been characterized as untruthful or misleading (e.g., that Xyrem was a “safe drug” despite the presence of a black box warning).  Until the Government makes its intentions about the Caronia decision abundantly clear, most manufacturers will continue to institute policies, practices and controls that steer clear of the Government’s reach.

While not appealing the Second Circuit’s decision might provide the Government with an expedient escape from the Caronia First Amendment thicket, most citizens should come to expect more from their Government.  It would indeed be disappointing if the Government settles quietly with Par, confines Caronia to the boundaries of the Second Circuit, and conducts business as usual — betting that most companies either won’t file a First Amendment challenge or will just use the First Amendment as leverage to get a better deal.  What citizens should expect from their Government, especially when it comes to matters of free speech and public health, is honesty and the pursuit of justice.  If the Government truly believes that relying solely on truthful, accurate and non-misleading off-label speech as evidence of intent to sell off-label in an enforcement action is not prohibited by the First Amendment, then it should appeal Caronia to the Supreme Court.  Alternatively, it should accept the Caronia decision and use it to draft a guidance document that would provide manufacturers with a meaningful First Amendment safe harbor — unlike the widely (and rightfully) criticized guidance document on “Responding to Unsolicited Requests for Off-Label Information” it issued a year ago.  Such a guidance document could start with the simple proposition that accurate, truthful and non-misleading off-label speech that is reviewed and approved by a manufacturer’s “promotional materials review committee” for accuracy, truthfulness and fair balance will not be used as evidence of intent to distribute/sell off-label, especially where the off-label use is medically accepted (as evidenced by inclusion in recognized medical compendia) and reimbursed by Medicare, Medicaid and/or other federal healthcare programs.

I’m just sayin’.


Update: Find out more from my recent webinar.


About Jose Sierra

José P. Sierra is a Principal in the Boston and Delaware offices of Fish & Richardson. Prior to joining the firm, Mr. Sierra was Senior Vice President, Chief Compliance and Ethics Officer for Sepracor Inc., a specialty pharmaceutical company. Earlier in his career he held positions as Vice President, Chief Compliance and Ethics Officer for Kos Pharmaceuticals, Inc., Legal Director at Schering-Plough Corporation, and Assistant U.S. Attorney in the U.S. Attorney’s Office in Newark, New Jersey.

Mr. Sierra works in the firm’s pharmaceutical and medical device industry practices focusing on litigation, government investigations, qui tam/whistleblower defense, compliance, and risk management. Contact him at 617-956-5926 or via .

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