Briefing Assesses Impact of U.S. v. Caronia Ruling on Regulation of Medical Communications, One Year Later

Greater Clarity Needed Regarding What Scientific Information Biopharmaceutical Companies Can Communicate to Healthcare Providers

01.31.14 | By Mit Spears

 The Washington Legal Foundation recently convened an enlightening expert roundtable discussion about the impact of late 2012's decision in U.S. vs. Caronia. 

The consensus about the speakers was that the decision's concrete impact has been limited, and that greater clarity is needed regarding the various ways in which pharmaceutical companies can and cannot communicate scientific information to physicians and other healthcare providers. 

As America's communication landscape changes – along with the evolution of the healthcare system – it is increasingly important for conversations like this to help us identify ways in which we can improve patient care and help physicians make better treatment decisions.

Below is a guest blog from Glenn G. Lammi, Chief Counsel at the Washington Legal Foundation, with his thoughts about a new regulatory paradigm for communication of information, from clinical data about medically accepted alternative uses of approved medicines to pharmacoeconomic data.​


In the immediate aftermath of the U.S. Court of Appeals for the Second Circuit’s December 3, 2012 U.S. v. Caronia decision, the reactions of some federal officials and public health activists bordered on apocalyptic.

Panelists at a recent Washington Legal Foundation (WLF) briefing, U.S. v. Caronia, One Year Later: The First Amendment and Federal Oversight of Off-Label Drug and Device “Promotion” conveyed that the decision’s actual implications are quite a bit more nuanced.  The program, which can be viewed in its entirety on WLF’s website, featured former Justice Department health care fraud enforcer Jonathan Diesenhaus (now a Hogan Lovells partner), Sidley Austin partner Coleen Klasmeier, and Pfizer Senior Vice President and Associate General Counsel Geoffrey Levitt.

“At the Justice Department, Caronia was met with two weeks of thoughtful inactivity,” related Mr. Diesenhaus.  Emerging from that inactivity, the speakers explained, was an effort that is still ongoing to marginalize the ruling.  That effort has included a strategic decision not to appeal Caronia and the release of carefully worded statements declaring the federal government undeterred from pursuing what it perceives as mislabeling and fraudulent behavior.  The Food and Drug Administration (FDA) and U.S. Department of Justice (DOJ), Ms. Klasmeier noted, have repeatedly stressed that Caronia did not address instances of false or misleading speech.  DOJ emphasized this point in a November 7, 2013 formal statement of interest in a federal whistleblower lawsuit, a document Ms. Klasmeier urged viewers to scrutinize.

Mr. Diesenhaus acknowledged that after Caronia, the Justice Department won’t be prosecuting individuals (such as sales reps) based solely on truthful statements on off-label uses.  He said that cases and settlements federal prosecutors have pursued against companies post-Caronia reflect the government’s focus on “speech plus,” i.e. allegations of unlawful off-label promotion along with kickbacks and other non-speech-related violations.  Those cases and settlements, Mr. Diesenhaus added, show that corporations still have much to fear in the wake of Caronia, as do senior company executives, which DOJ can and will pursue under the “responsible corporate officer” doctrine.

Looking forward, the speakers agreed that the most promising prospect for a successful, broad-based First Amendment challenge to the government’s approach to off-label speech lies in the context of what they called “CER asymmetry.”  Reforms of the U.S. healthcare system have placed an emphasis on CER—comparative effectiveness research—as a means of maximizing value and minimizing costs for treatments.  As Mr. Levitt explained, third-party payors, doctors, “counter-detailers” and others are free to discuss off-label uses and share information, such as observational studies, meta-analyses, or comparative analyses, which FDA would not consider “substantial evidence” of a product’s effectiveness.  Drug and device makers, however, cannot freely share such information, even under Section 114 of the Food and Drug Administration Modernization Act (FDAMA), which Congress passed in 1997 to encourage exchange of “healthcare economic information.”  FDA has done nothing, Ms. Klasmeier added, to implement that FDAMA provision.

This CER asymmetry highlights the speaker- and viewpoint-based nature of federal rules on off-label speech.  Recent Supreme Court decisions, such as Sorrell v. IMS Health, Ms. Klasmeier said, cast serious doubt on government policies that discriminate against certain speakers in favor of others.  Mr. Levitt stressed that while the government may be able to prove it has a compelling reason to restrict manufacturers’ speech on off-label uses, it will be difficult to show that no policy alternative less restrictive of speech exists to advance that compelling interest.  He argued rules could constitutionally focus on full transparency when studies discuss off-label uses and fall short of FDA’s crabbed definition of “substantial evidence.”

Ms. Klasmeier added that due process challenges could be another promising avenue for regulated entities who must navigate FDA’s perilous and consciously vague regulations for off-label speech.  The Supreme Court’s unanimous 2012 FCC v. Fox Television Stations (Fox II) ruling reflects that the Due Process Clause requires regulated entities to be provided fair notice of what conduct is prohibited under law.  Ms. Klasmeier pointed to a 2013 federal district court decision, Wilson v. Frito-Lay NA, which cited Fox II when ruling on a private class action lawsuit alleging fraudulent food labeling, as one instance where judges are contemplating due process in the context of FDA regulation.

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