Tom Abrams: Caronia Won't Stop Off-Label Enforcement

The much-discussedUS v. Caronia case, which has raised questions about the Food and Drug Administration prosecution of pharma companies for making off-label product claims, doesn’t change very much, according to FDA’s top drug marketing enforcer.

Speaking at the CBI Pharmaceutical Compliance Congress in Washington DC this week, Tom Abrams, director of the Office of Prescription Drug Promotion (OPDP) in the Center for Drug Evaluation and Research (CDER), said that the government is not seeking further review of the Caronia decision, largely because the decision “does not find a conflict between the Act’s misbranding provisions and the First Amendment.”

In fact, the Court of Appeals decision didn’t challenge FDA’s contention that promoting a drug for unapproved uses may be evidence of misbranding. Thus, the Second Circuit ruling – which involved a divided panel, Abrams emphasized – “does not bar the government from continuing to enforce the misbranding provisions of the FD&C Act.” After delivering his remarks on the Caronia case, Abrams told the audience that he would not take any questions on the subject. Maame Ewusi-Mensah Frimpong, deputy assistant attorney general, consumer protection branch, civil division, at the US Department of Justice, noted during a separate CBI panel that shortly after Caronia, an off-label Amgen settlement went through the Second Circuit, the same court that found in favor of Caronia, without all of the First Amendment fanfare.

Here’s Abrams’ full statement:

The government has determined not to seek further review of the Second Circuit’s decision in United States v. Caronia, No. 09-5006-cr (2d Cir.).  FDA does not believe that the Caronia decision will significantly affect the agency’s enforcement of the drug misbranding provisions of the Food, Drug, and Cosmetic Act (FD&C Act).

In 2009, Alfred Caronia was convicted of conspiring to distribute a misbranded drug in violation of the FD&C Act.  A divided panel of the Second Circuit held that the jury instructions erroneously permitted, and that the government’s argument encouraged, the jury to treat speech promoting unapproved (off-label) uses of an FDA-approved drug as a criminal offense in and of itself.  The court of appeals did not address the constitutionality of the theory of liability on which the government had defended the conviction:  namely, that the promotion of a drug for an unapproved use may be relied on as evidence that the unapproved use is an intended one, and a drug that lacks adequate directions for its intended uses is misbranded.

Because the court did not address the constitutionality of a prosecution resting on that theory, and because the court also acknowledged that the First Amendment does not preclude an enforcement action based on speech regarding unapproved uses that is false or misleading, the Second Circuit’s decision does not bar the government from continuing to enforce the misbranding provisions of the FD&C Act, including through criminal prosecution where appropriate, in cases involving off-label promotion.  More generally, the decision does not strike down any provision of the FD&C Act or its implementing regulations, nor does it find a conflict between the Act’s misbranding provisions and the First Amendment or call into question the validity of the Act’s drug approval framework.

Abrams said that pharmaceutical promotional materials are “improving,” and that strong voluntary compliance by industry is critical for OPDP to be able to oversee some 80,000 promotional pieces a year. In general, pharma ads appear to be less violative, and of a higher quality, though some materials still present cause for concern, said Abrams. OPDP has “zero tolerance for misleading promotion,” he said. In response to a question from the audience on whether OPDP would tread lightly on a company if it voluntarily reported a promotional misstep or mistake, Abrams reiterated the need for voluntary compliance, and said OPDP would hardly ever take an action if a mistake is self-reported, and also corrected. Given the number of promotional materials OPDP is tasked with reviewing each year, the agency must set priorities, said Abrams. Those priorities include ads for newly approved products, drugs with significant risks and products subject to past violations and complaints.

With respect to policy and guidance documents for industry, Abrams once again stated that social media guidelines are among the agency’s “top priorities,” in addition to other areas of interest, including the use of health economic information in making formulary decisions, and the addition of comparative effectiveness claims in a drug’s label.

Additional reporting contributed by Ben Comer.