New Twists and Turns in Off-Label Marketing

By John R. Fleder –

It is no secret that the government has devoted considerable resources in recent years seeking to combat what it has contended is wide-spread illegal off-label marketing and promotion of devices and drugs.  Many people believe that the government has created this “problem” because of its long-standing lack of clarity regarding what is, and is not, acceptable practices for drug and device companies.  This uncertainty as to what is or is not illegal conduct has recently become even more cloudy because of positions the government has taken in recent litigation.

United States v. Caronia is just one of many off-label criminal cases.  Caronia was convicted of conspiring to introduce misbranded drugs into interstate commerce because those drugs allegedly did not have adequate directions for use.  His appeal of that conviction has raised some interesting issues in the briefs filed in that case, which are available here, here, and here.

First, it is noteworthy that the United States Court of Appeals for the Second Circuit on its own called for supplemental briefing in the case.  It had the litigants brief the applicability of Sorrell v. IMS Health Inc., 131 S. Ct. 2653 (2011), to the Caronia case.  In Sorrell, the Supreme Court ruled that a Vermont statute regulating certain speaker and content-based restrictions relating to pharmaceutical companies violated the First Amendment of the U.S. Constitution.  The Court of Appeals obviously read Sorrell and presumably thought that it does impact the Caronia appeal in some fashion.

One of the appellate briefs supporting Mr. Caronia’s appeal was filed by the Medical Information Working Group (MIWG), a group composed of eleven major pharmaceutical companies.  The brief argues that the FDA’s off-label regulations “are no less speaker- and content-based than was the law at issue in Sorrell.”  MIWG Amicus Brief at 1-2.  The brief also argues that there is indeed significant ambiguity regarding precisely what speech is proscribed by the FDCA, as construed and applied by FDA and the Department of Justice.

The brief also makes a number of very interesting assertions including that:

• The government has represented to courts that the presence of off-label promotion is a sufficient condition for the government to obtain a misbranding conviction, citing to the government’s proposed jury instructions in the Caronia case, which the court used to charge the jury.  The government stated in the recent Lauren Stevens case, however, that if a company pays a physician to provide an educational presentation to doctors, the manufacturer is subject to criminal prosecution if that physician affirmatively discusses the off-label use, but the same manufacturer will not be subject to prosecution if the physician provides the same information in response to an audience member’s unsolicited request.
• The government has asserted that a manufacturer cannot expressly or implicitly promote the safety or efficacy of an off-label use but can disseminate safety warnings that discourage that use.
• The government represented to the Court of Appeals in Caronia that off-label promotion is not itself a crime.
• The government stated in oral argument that a manufacturer would not be committing a crime by selling a drug or device without adequate directions for use merely because the manufacturer knew that its product was going to be used off-label. Thus, the government told the court that a manufacturer may lawfully ship a drug that it knows will be used by a physician off-label.

The government has also submitted a supplemental appellate brief in the Caronia case.  Seeking to avoid any Sorrell issue, the government is claiming that the fact that a drug was promoted for unapproved uses merely plays “an evidentiary role in” the FDCA, apparently to show that FDA is not really prohibiting speech.  In other words, the government contends that in off-label cases, the government uses the off-label speech as mere evidence of the manufacturer’s intent.  It then claims that Mr. Caronia was not convicted for conspiring to promote off-label uses.  Rather, he was convicted for distributing the drug without adequate directions for use.

While perhaps literally true, this distinction proves too much.  It shows that the government is trying to stretch an “adequate directions for use” theory to prosecute people for off-label use promotion because the statute is silent on whether it prohibits off-label use promotion.  Indeed, the government asserts that it is not restricting the dissemination of information.  Instead, it claims that it is merely following the statutory mandate that certain information must be provided to doctors (presumably only after a full FDA review of the information).  The government thus likens the “adequate directions for use” language to a “disclosure” requirement.  Indeed, the government asserts that the off-label use misbranding charges are intended “to provide the public with reliable information about the medicines they are using.”  It is of course ironic that in fact the FDA is really trying to restrict companies from providing off-label information to the public unless, of course, the FDA has approved the use.

The government also asserts that Sorrell does not alter the First Amendment cases decided before Sorrell which applied less scrutiny over the government’s statutes and regulations than the “heightened scrutiny” the Court applied in Sorrell.  The government also dismisses the MIWG brief as untimely, irrelevant and without merit.  It asserts that “the fact that an unapproved use is widely accepted in the medical community is no assurance that the drug is, in fact, either safe or effective for that use.”  The government also concedes that “to the extent that manufacturers have objective, accurate, and unbiased information about unapproved uses of approved drugs, the misbranding provisions do not prohibit manufacturers from disseminating that information.”   Addressing FDA’s guidance documents on this subject, the government asserts that manufacturers need not comply with the guidance documents but can use them as “clearly defined safe harbors.”

Undoubtedly, there must be someone who can understand, find clear legal support for, and find consistency in, the government’s many pronouncements on off label use and marketing.  That person is surely not the author of this post.