Off-label drug marketing gets free-speech protection in court ruling

Judges say the government cannot prosecute for promotion of accepted off-label uses of FDA-approved drugs. Some medical experts worry that drug benefits will be overstated.

By — Posted Dec. 24, 2012

Print  |   Email  |   Respond  |   Reprints  |   Like Facebook  |   Share Twitter  |   Tweet Linkedin

Pharmaceutical representatives now can tell physicians about appropriate off-label uses for their medications without penalty after a federal appeals ruling legitimized the practice.

The 2nd U.S. Circuit Court of Appeals on Dec. 3 ruled that blocking drug companies from promoting truthful statements about off-label drug uses violates the First Amendment. The decision exonerates former Orphan Medical Inc. drug representative Alfred Caronia, who was convicted of illegally marketing narcolepsy drug Xyrem (sodium oxybate) for uses that were not described in the drug’s labeling.

The ruling enables the free flow of honest information between drug reps, physicians and others, said Thomas F. Liotti, Caronia’s attorney.

“It was always the case that doctors could speak to other doctors about off-label uses, and that was considered legal,” he said. The Food and Drug Administration was “basically discriminating against the sales reps and the manufacturers when they, too, should have a right to talk about scientific and medical studies about off-label use.”

The Dept. of Justice and the FDA declined to comment on the ruling. At this article’s deadline, the Justice Dept. had not decided if it would appeal the case to the U.S. Supreme Court, a spokesman said.

Some medical experts are concerned that the court decision will encourage drug companies to mislead physicians about the benefits of their medications.

“Physicians are already confused about what is off- and what is on-label,” said Adriane Fugh-Berman, MD, a pharmacology professor at Georgetown University Medical Center in Washington. She is director of PharmedOut, a grant-funded project that educates health professionals about pharmaceutical marketing.

“This ruling frees the industry to promote drugs for uses in which the risks have not been shown to outweigh the benefits,” Dr. Fugh-Berman said. “It expands the industry’s ability to [market] drugs based on” efficacy claims rather than evidence.

A doctor found liabile

The case involves Caronia’s promotion of Xyrem for several uses not approved by the FDA. At the time, Xyrem, a strong nervous system depressant, was approved by the FDA to treat weak muscles and sleep disorders in narcoleptic patients, according to court documents. The drug was manufactured by Orphan Medical Inc., now known as Jazz Pharmaceutical.

Federal investigators found that Caronia was recommending Xyrem to physicians for patients with fibromyalgia, restless leg syndrome and chronic fatigue. Under the federal Food Drug and Cosmetic Act, drugmakers are prohibited from marketing drugs for unapproved uses. Caronia was indicted in 2007 for conspiracy to introduce a misbranded drug into interstate commerce.

Psychiatrist Peter Gleason, MD, a promotional speaker hired by Orphan, also was charged for his involvement in advocating Xyrem for off-label uses. Although it is legal for physicians to discuss off-label uses with other doctors, Dr. Gleason was charged with promoting Xyrem for potentially dangerous uses on Orphan’s behalf. Dr. Gleason, now deceased, pleaded guilty to the charges.

Caronia requested that his charges be thrown out because the Food Drug and Cosmetic Act’s misbranding provisions unconstitutionally restricted his right to free speech under the First Amendment. The government contended that Caronia was not prosecuted for his speech, but rather because his promotion of Xyrem was equivalent to misbranding the drug for uses for which its labeling failed to provide any directions, court documents said.

A district court denied Caronia’s motion to dismiss, and in 2008, a jury found Caronia guilty. He appealed to the 2nd U.S. Circuit Court of Appeals.

In their opinion, appeals court judges questioned the FDA’s intent behind prosecuting drug companies for sharing information about off-label uses.

“If the government’s objective is to shepherd physicians to prescribe drugs only on-label, criminalizing manufacturer promotion of off-label use while permitting others to promote such use to physicians is an indirect and questionably effective means to achieve that goal,” the panel said. It later added, “The government clearly prosecuted Caronia for his words — for his speech. The government cannot prosecute pharmaceutical manufacturers and their representatives under the [Food Drug and Cosmetic Act] for speech promoting the lawful, off-label use of an FDA-approved drug.”

Legislative change advocated

The court was correct to recognize that the FDA’s ability to regulate communication about medicines is circumscribed by the rights protected by the First Amendment, said Matthew Bennett, senior vice president for Pharmaceutical Research and Manufacturers of America.

As previous courts have affirmed, “speech by biopharmaceutical companies is protected by the First Amendment, and any policy that restricts speech by biopharmaceutical companies, while allowing others to freely engage in similar speech, is subject to heightened constitutional scrutiny,” Bennett said. “Truthful and nonmisleading communication between biopharmaceutical companies and health care professionals is good for patients, because it facilitates the exchange of up-to-date and scientifically accurate information about new treatments.”

While the ruling draws attention to the issue of off-label promotion, there remains a need for the FDA to revise its regulations about off-label marketing of drugs, said Mark Mansour, an international food and drug law attorney based in Washington.

“Technology moves quickly, and research and practice often reveal off-label benefits at a far more rapid pace than FDA’s resources permit evaluation of off-label uses,” he said. “It is only a matter of time before the industry, FDA, doctors, consumers and the courts will have to rely on Congress, the medical community and FDA to come up with ideas that would form the basis for a revision of the regulation of off-label use.”

The American Medical Association supports the need for physicians to have access to accurate and unbiased information about unlabeled uses of drugs and devices, while ensuring that manufacturer-sponsored promotions remain under FDA regulation. The association “supports the dissemination of independently derived scientific information about unlabeled uses by manufacturers to physicians, if the independent information is provided in its entirety, is not edited or altered by the manufacturer, and is clearly distinguished from manufacturer-sponsored materials,” AMA policy states.

Back to top


Case at a glance

Should drug representatives be allowed to promote off-label drug uses to physicians?

The 2nd U.S. Circuit Court of Appeals says yes. The court said the government cannot prosecute pharmaceutical manufacturers and their representatives under federal law for speech promoting the lawful, off-label use of an FDA-approved drug.

Impact: Some experts said the ruling could encourage drug companies to mislead doctors about the benefits of medications. Others said the decision supports the free flow of honest information between drug reps and physicians.

United States v. Caronia, 2nd U.S. Circuit Court of Appeals, Dec. 3

Back to top



Read story

Confronting bias against obese patients

Medical educators are starting to raise awareness about how weight-related stigma can impair patient-physician communication and the treatment of obesity. Read story

Read story


American Medical News is ceasing publication after 55 years of serving physicians by keeping them informed of their rapidly changing profession. Read story

Read story

Policing medical practice employees after work

Doctors can try to regulate staff actions outside the office, but they must watch what they try to stamp out and how they do it. Read story

Read story

Diabetes prevention: Set on a course for lifestyle change

The YMCA's evidence-based program is helping prediabetic patients eat right, get active and lose weight. Read story

Read story

Medicaid's muddled preventive care picture

The health system reform law promises no-cost coverage of a lengthy list of screenings and other prevention services, but some beneficiaries still might miss out. Read story

Read story

How to get tax breaks for your medical practice

Federal, state and local governments offer doctors incentives because practices are recognized as economic engines. But physicians must know how and where to find them. Read story

Read story

Advance pay ACOs: A down payment on Medicare's future

Accountable care organizations that pay doctors up-front bring practice improvements, but it's unclear yet if program actuaries will see a return on investment. Read story

Read story

Physician liability: Your team, your legal risk

When health care team members drop the ball, it's often doctors who end up in court. How can physicians improve such care and avoid risks? Read story

  • Stay informed
  • Twitter
  • Facebook
  • RSS
  • LinkedIn