A recent case before the Second Circuit Court of Appeals highlights the challenges inherent in protecting diverse interests. In this case, the opposing interests are freedom of speech vs restricting drug marketing to FDA-approved indications.
First, a little background: In the US, drugs must be approved by the FDA before they can be marketed. Drug reps can only promote drugs for approved indications which appear on the FDA label. Doctors, on the other hand, are free to discuss any data they want. Further, doctors can prescribe drugs for any indication (not just on-label indications). The stakes are high. In past cases, drug companies that have engaged in off-label promotion have paid fines costing hundreds of millions or even billions of dollars (Eli Lilly paid $1.4 billion for their off-label promotion of Zyprexa and Pfizer paid $2.3 billion for their off label promotion of the three drugs Bextra, Lyrica, and Geodon).
The case in question is that of United States v. Caronia, in which the government accused (and initially convicted) drug rep Alfred Caronia of off-label drug promotion of the drug Xyrem. Mr Caronia was caught on tape discussing that Xyrem, which is approved for narcolepsy, could also be used for treating pain and fibromyalgia.
The Court’s 82-page decision found that Mr Caronia’s off-label discussion of Xyrem was protected by the First Amendment. The Court determined that, since there are criminal penalties associated with off-label promotion, the ‘on-label promotion’ restriction must be subject to a high level of scrutiny. The Court looked at two issues: ‘content’ and ‘speaker.’ In terms of content, Mr Caronia was deemed by the Court to be discussing something legal, since doctors are permitted to prescribe medications off-label. In terms of speaker, the law permits doctors to discuss off-label use of drugs. The law selectively restricts who can engage in such speech (in this case, drug reps are precluded from such speech).
On page 51 of the decision, the Court writes that “the government cannot prosecute pharmaceutical manufacturers and their representatives under the [Federal Food, Drug, and Cosmetic Act of 1938] for speech promoting the lawful, off-label use of an FDA-approved drug.” Stated another way, the court concluded that drug reps may legally engage in off-label drug promotion as this constitutes free speech and is protected under the First Amendment.
I think the Court reached the wrong conclusion. While I agree that free speech with unrestrcited flow of information is a cornerstone of our society, I believe the key element that the Court failed to weigh appropriately is the conflict of interest that drug reps have.
The issue in my mind is similar to that of making false claims, which is within the purview the Federal Trade Commission and is illegal. In short, the FTC regulates advertising and prohibits deceptive practices in order to protect the public interest. Without such consumer protection, a company marketing its products (especially one with deep pockets and a potentially loud voice) could make false but seemingly credible claims and then benefit from resulting sales. Drug companies (and their sales reps) have this same conflict of interest. Drug reps are responsible for selling drugs and generating as much in sales as they can.
In making off-label claims, a drug rep might make statements that are narrowly true but that are nonetheless false when looked at in totality of the information that exists. For example, imagine that a company did 100 studies to test whether a drug cured headaches. If 99 of those studies failed but one was successful, the reasonable conclusion is that the successful trial was a fluke and that the drug does not work for treating headaches. However, under this recent ruling, a drug rep might legally discuss the successful trial showing efficacy of this drug in treating headache. The statement would be true, but the marketing would be false.
Indeed, if this decision stands, a pharmaceutical company could have the incentive to get a drug approved for one narrow indication only, then market that drug however they see fit. The current system ensures that drug companies do adequate studies ensuring adequate assessment of benefit for a given condition (which is then checked by the FDA) before they can market a drug for that indication. [Judge Debra Ann Livingston made this point in her opinion that dissented from the two judges who rendered the majority decision.]
Doctors are overwhelmed by responsibilities, one of which is to stay informed about medical data and good medical practice. There are thousands of medical journals with new data being reported weekly. Doctors can’t keep on top of everything. Drug reps can and sometimes do serve as a source of information for doctors. Doctors currently can rely on this information because it has been vetted by the FDA. The FDA serves as the arbiter of information’s completeness, truth, and reliability such that doctors can be comfortable that information from drug ads and drug reps is valid and correct in its totality.
Even with the restrictions on what drug reps can say (promoting drugs according to their FDA labels) there remains full freedom of speech in my opinion. Doctors and scientists are free to conduct trials and to discuss the results. Indeed, this freedom of doctors to discuss their research is essential to medical progress and dissemination of information. Further, drug companies can provide subsidies and funding to scientists to promote such discourse.
In summary, I believe the issue is one of precluding false advertising in order to protect the public interest. For all the reasons above, if this case goes to the Supreme Court, I hope the decision gets reversed.
sources: United States v. Caronia No. 09-5006-cr, 2012 WL 5992141, — F.3d — (2d Cir. Dec. 3, 2012); List of off-label promotion fines (Wikipedia); Off-Label Marketing and the First Amendment (NEJM); Second Circuit Holds that the First Amendment Protects Speech Promoting Off-Label Drug Use (Quarles & Brady); FTC Policy Statement on Deception