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Exploring Impact of US v. Caronia

On December 3, 2012, the 2nd US Circuit Court of Appeals vacated the conviction of former pharmaceutical company sales rep Alfred Caronia for promoting a drug for a use that had not been approved by the FDA. This is called off-label use.

In 2010, Caronia was convicted of conspiracy to introduce a misbranded drug into interstate commerce, in violation of the Federal Drug & Cosmetic Act (FDAC). His appeal successfully contended that he was convicted for his speech – speech that promoted the off-label, but legal, use of an approved prescription drug – which violates his First Amendment right to free speech. In its ruling, the Court concluded that Mr. Caronia had been prosecuted and convicted for “mere off-label promotion,” and that “we construe the FDCA as not criminalizing the simple promotion of a drug’s off-label use because such a construction would raise First Amendment concerns.”

The Court further ruled that it interprets “the misbranding provisions of the FDCA as not prohibiting and criminalizing the truthful off-label promotion of FDA-approved prescription drugs” and “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.”

John KampOn January 23, the DIA webinar Off-label Marketing Regulation in the Wake of the US v. Caronia Decision (#13209) reviewed highlights of the legal facts and history and some of the implications for regulatory and industry professionals, that are sure to follow one of the most significant, recent commercial free speech decisions by a federal appeals court. This webinar explored the dimensions of conversations and decisions that will arise from the aftermath of this decision. “This decision is far from over,” cautioned webinar moderator John F. Kamp, JD, PhD (Wiley Rein LLP).

Bert W. Rein (Wiley Rein LLP) summarized the history of this decision, the great divide between its majority and dissenting opinions (2-1), and what he called “the eternal disconnect in the regulation of drugs and devices.” On the one hand, he explained, FDAC gives FDA the authority to approve pharmaceuticals for market use which have demonstrably proven, through rigorous testing and review, to be adequately safe and effective for a specific therapeutic 
purpose. On the other hand, the FDAC does not give FDA authority to regulate the practice of medicine, and it is not illegal for a physician or other authorized caregiver to prescribe a pharmaceutical product if the prescriber deems it helpful for that patient.

“What do you do with a lawfully distributed product when additional information changes use patterns?” asked Mr. Rein. Questions abound: Does the FDAC authorize FDA to regulate the pharmaceutical product or to regulate the speech through which that product is distributed and administered? Does FDA regulate the manufacturer, who tests and gets a product approved for a specific therapeutic indication, or the prescriber, who can legally prescribe the product outside that approved indication?

Alan R. Bennett JD (Ropes & Grey) examined the evidentiary implications of Caronia. “There are four things that the case can actually be said to stand for,” he began:

  • Off-label use is a legal activity
  • Pure speech about a legal activity cannot be prohibited
  • False or misleading speech can be regulated
  • These leave open the question of whether speech can be evidence

Mr. Bennett suggested that the government will most likely move forward by structuring new investigative strategies to develop evidence that goes beyond promotional speech (such as internal marketing plans or directions to sales representatives), and will attempt to further “Caronia proof” their investigations by more clearly stating that promotional speech is only offered as evidence of intent of intended off-label use.

FDA will also have to focus on “false or misleading” promotion, which may not only force the agency to prove the speech in question is “false or misleading” but may open debate over the definition of “false or misleading” and perhaps even who gets to define it. “There is nothing in the First Amendment that bars false or misleading speech,” Mr. Bennett explained. “That is the key question: What is the ultimate scope of the First Amendment here?”

In his presentation “US v. Caronia: A Victory for Patients,” James “Mit” Spears, JD (Pharmaceutical Research & Manufacturers of America [PhRMA]) proposed that Caronia is nothing less than a reaffirmation of the constitutional principle of free speech. FDA and Justice Department policies around promotional speech are rooted in the past, he suggested, when such discussions were primarily between industry, regulators and prescribers. Patients, and more recently payers, have now emerged as discussants, too.

But the only voice subject to regulation through all these conversations is the voice that works for or otherwise represents the pharmaceutical company, such as Mr. Caronia’s. All other parties can freely speak. “I don’t understand how you can decide what is promotional,” Mr. Spears said. “Any piece of information that I share about my product can be seen as promotional.”

Mr. Spears further pointed out that off-label use is a common and widely accepted medical practice. Not only is it legal, but 50% of all oncology prescriptions are for off-label use; off-label use may constitute the standard of care in certain therapeutic areas, he continued, and is recognized as such by Medicare/Medicaid and other reimbursement plans.

Caronia highlights the disconnect between legal and acceptable off-label use and speech that promotes off-label use, for which Mr. Caronia was convicted and whose conviction was subsequently overturned, Mr. Spears said in summary. It can help us move toward a new regulatory paradigm based on truthful, non-deceptive communications (including promotional speech) that will yield better outcomes for patients. “Speech without intent is meaningless,” he concluded.