Free speech rights outweigh restrictions on promoting drugs off label, court rules

BMJ 2012; 345 doi: (Published 06 December 2012) Cite this as: BMJ 2012;345:e8324
  1. Bob Roehr
  1. 1Washington, DC

A federal appeals court in New York has ruled that regulations prohibiting the off-label promotion of prescription drugs are a violation of constitutionally protected free speech.1 The decision in the United States v Caronia case is likely to be appealed.

The drug at the center of the case is sodium oxybate (marketed in the US as Xyrem), which carries two label indications to treat conditions associated with narcolepsy. Data are insufficient to extend the label indication to children and elderly people, and it carries a “black box” warning of side effects.

A drug sales representative, Alfred Caronia, argued that regulations of the Food and Drug Administration limiting promotional activity only to the label indication of an approved drug were a violation of his rights to free speech under the First Amendment. He worked for Orphan Medical, the company that marketed sodium oxybate in the US, since acquired by Jazz Pharmaceuticals, and said that he should be allowed to promote off-label use as well.

In 2009 a jury agreed with government prosecutors that Caronia did promote off-label use but did not rule on the constitutional question of whether that promotion conflicted with First Amendment protections.

The case was appealed to a three judge panel of the US Court of Appeals for the Second Circuit, which grappled with the constitutional issue.

In the middle of all these legal proceedings, in June 2011, the US Supreme Court ruled in Sorrell v IMS Health that pharmaceutical marketing was free speech protected by the First Amendment.2 It outlined steps that the government must take to justify restraint of that speech.

Two of the Second Circuit judges found that off-label drug use was a lawful activity, “and the promotion of off-label drug use is not in and of itself false or misleading,” wrote Judge Denny Chin. Furthermore, “the FDA’s drug approval process generally contemplates that approved drugs will be used in off-label ways” by physicians and patients. An estimated 80% of clinical treatment guidelines are not based on evidence rigorous enough to secure an FDA label indication.

Allowing this use, and encouraging healthcare professionals to publish in journals on off-label use, while prohibiting companies from commenting on the same drug “interferes with the ability of physicians and patients to receive potentially relevant treatment information; such barriers to information about off-label use could inhibit, to the public’s detriment, informed and intelligent treatment decisions,” the opinion read.

The third judge did not concur. “If drug manufacturers were allowed to promote FDA-approved drugs for non-approved uses, they would have little incentive to seek FDA approval for those uses,” wrote Judge Debra Ann Livingston in dissent. She called the regulations “a necessary tool for the effective functioning of a regulatory system.”

An FDA spokesman cited the agency’s policy of not commenting on pending litigation.

The trade group Pharmaceutical Research and Manufacturers of America (PhRMA) said it was “pleased” by the ruling. In a news release it said, “PhRMA believes that truthful and non-misleading communication between biopharmaceutical companies and healthcare professionals is good for patients because it facilitates the exchange of up-to-date and scientifically accurate information about new treatments.”

The Obama administration has been particularly aggressive in prosecuting off-label promotion by the drug industry, which has paid billions to settle claims.3 The scope of those prosecutions is likely to narrow considerably if the latest ruling stands.


Cite this as: BMJ 2012;345:e8324