Law & Medicine

Doctors, drug reps, and free speech


 

Question: The First Amendment guarantees the right of free speech, but the U.S. Supreme Court has held that under a strict scrutiny standard, the government may regulate:

A. Obscenity.

B. Fighting words.

C. Professional speech.

D. A and B.

E. A, B, and C.

Answer: D. The First Amendment forbids the government from “abridging the freedom of speech,” which extends to certain nonverbal conduct, such as flag burning. At the same time, the U.S. Supreme Court has also ruled that certain categories of speech such as obscenity and fighting words can be regulated under a strict scrutiny standard. However, it remains unsettled whether and to what extent professional speech – such as in the context of the doctor-patient relationship – may be curtailed.

Two recent cases grapple with this issue of free speech – with rather unexpected results.

The first, overturning a decades-old prohibition of the off-label detailing of drugs, surprisingly was decided against the government. The second challenges a Florida statute censoring the discussion of firearms safety between a doctor and a patient. An early decision, under reconsideration, in fact supported the state’s regulation of physicians’ freedom of speech under the circumstances.

Dr. S.Y. Tan

Dr. S.Y. Tan

Over many decades, the Food and Drug Administration has been the sole and final arbiter of what information goes on the labels of medical drugs and devices, based on scientific evidence of safety and efficacy. The specific usage of a drug, i.e., its approved on-label use, is clearly marked. If a manufacturer attempts to recommend usage or disseminate information that has not been approved by the FDA, such “off-label” promotion is considered misbranding, and has regularly met with heavy fines and other penalties.

Because the FDA has no jurisdiction over physician conduct, it has no power to regulate the off-label use of an otherwise approved drug, which explains why such off-label prescriptions are widespread, especially in the oncology field.

In U.S. v. Caronia, the defendant, a pharmaceutical sales representative, was criminally prosecuted and found guilty of conspiracy in a New York court for introducing a misbranded drug into interstate commerce.1 Specifically, Alfred Caronia promoted the drug Xyrem for use in a manner not approved by the FDA.

Orphan Medical, now known as Jazz Pharmaceuticals, is the manufacturer of Xyrem, a powerful central nervous system depressant. Xyrem’s active ingredient is gamma-hydroxybutyrate, which has been federally classified as the “date rape drug” for its use in the commission of sexual assaults. The FDA had approved Xyrem for two conditions: to treat narcolepsy patients who experience cataplexy, a condition associated with weak or paralyzed muscles; and to treat those with excessive daytime sleepiness.

Caronia was found to provide off-label detailing of the drug to doctors for unapproved indications such as chronic fatigue, fibromyalgia, restless leg syndrome, and Parkinson’s disease.

Caronia argued that in promoting an FDA-approved drug, albeit for off-label use, he was within his right of free speech under the First Amendment. In overturning his conviction, a three-judge panel of the U.S. Second Circuit Court of Appeals agreed, noting the overly broad FDA regulations and specifically that nothing Caronia did constituted conspiracy to put a false or misleading or deficient label on a drug product.

The court concluded: “The government cannot prosecute pharmaceutical manufacturers and their representatives under the FDCA [Federal Food, Drug, and Cosmetic Act] for speech promoting the lawful, off-label use of an FDA-approved drug.”

In 2011, the U.S. Supreme Court had used a First Amendment argument to invalidate a Vermont law that prohibited the practice of pharmaceutical data mining – purchasing information about prescribers from pharmacies and others.2

Taken together, the FDA now appears resigned to the free speech argument.3 For example, it has decided not to appeal a judge’s ruling that the First Amendment protects Amarin from promoting its fish-oil capsules for unapproved uses. Just recently, the FDA published a draft proposal in tacit acceptance of this new policy position, merely recommending the disclosure of relevant information including limitations and unfavorable or inconsistent findings surrounding the off-label use of a drug.

The next issue concerns professional speech. It is well documented that the presence of a gun in the home increases the risk of death especially by suicide, and this serves as the impetus for the long-established recommendation that physicians discuss firearm safety with their patients.

The medical profession was therefore aghast when Florida enacted its law on “Privacy of Firearm Owners.”4 Codified on June 2, 2011, it provides that a licensed practitioner or facility may not record firearm ownership information in a patient’s medical record, and that unless information is relevant to the patient’s medical care or safety or safety of others, inquiries regarding firearm ownership or possession should not be made. A practitioner is also forbidden from unnecessarily harassing a patient about firearm ownership during an examination.

Violation can result in disciplinary action; the original intent was to make this a third-degree felony with penalties of up to $5 million in fines and 5 years of imprisonment, but the final bill was stripped of criminal penalties.

In July 2015, a panel of three judges of the U.S. 11th Circuit Court of Appeals, in a split 2-1 decision, found that the inquiry, record-keeping, and harassment provisions of the act specifically regulate professional speech, which is subject to an intermediate level of scrutiny. Under this level of scrutiny, the court found that the act was precisely tailored to directly advance the state’s substantial interests in protecting the public and patient privacy rights.

Holding that the act was not so overly broad as to violate the First Amendment, the court ruled that laws regulating speech that occurs in the course of the physician-patient relationship are constitutional if they directly advance a substantial state interest.5

Predictably, several medical societies, including the AMA, have filed briefs arguing that the law is unconstitutional and intrudes on the practice of medicine. Effective medical care is believed to require “unfettered communications” between physicians and their patients. Besides, the law is at odds with the AMA’s longstanding policy that encourages members to inquire into the presence of firearms in households and to promote the use of safety locks on guns in an effort to reduce injuries to children.

On June 21, 2016, the full 11th Circuit Court of Appeals (sitting “en banc”) heard arguments, and the profession eagerly awaits its final opinion.

Meanwhile, commentators have expressed concerns that such laws threaten the sanctity of the physician-patient relationship, which relies on truthful communication to freely counsel patients.

This infringement may be gathering force. Missouri and Montana already have similar gun privacy laws, while other states have required physicians to keep confidential any information regarding chemicals used in fracking, or mandate the provision of various birth-related information prior to a woman’s decision to have an abortion.6

References

1. U.S. v. Caronia, 703 F.3d 149 (2d Cir. 2012).

2. Sorrell v. IMS Health, 131 S. Ct. 2653 (2011).

3. N Engl J Med. 2013 Jan 10;368(2):103-5.

4. Fla. St. 381.026, 456.072, 790.338.

5. Wollschlaeger v. Governor of Florida, 797 F.3d 859 (11th Cir. 2015).

6. N Engl J Med. 2016 Jun 16;374(24):2304-7.

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at [email protected].

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