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Promotion of Off-Label Use Not Always a Crime

[March 15, 2013, AJHP News]

Cheryl A. Thompson

BETHESDA, MD 26 Feb 2013—In a ruling that may affect drug communications in only three states, a federal appeals court has decided that "the simple promotion of a drug’s off-label use" is not a crime.

FDA in January announced it would not pursue a review of the court’s decision.

In making that announcement, the agency also said the court’s decision "does not bar the government from continuing to enforce the misbranding provisions" of the Food, Drug, and Cosmetic Act "in cases involving off-label promotion."

William Fassett, a professor of pharmacy law and ethics at Washington State University in Spokane, predicted that drug company representatives will probably not start speaking freely about off-label uses as a result of the court’s and FDA’s decisions.

But the ruling and FDA’s guidance for the pharmaceutical industry on responding to unsolicited requests for off-label information about prescription drugs may prompt some company representatives to start circulating reprints of medical journal articles on off-label uses, he said.

That guidance was issued as a draft in December 2011. FDA has not yet released the final version.

Fassett said the ruling heightens the importance of formularies and pharmacists providing drug information in health systems.

The Food, Drug, and Cosmetic Act, he explained, compels FDA "to approve drugs that many thoughtful hospital formularies would never include."

"Pharmacists exercising their right to speak about products with authority and to make recommendations within their institutions is actually considered probably the best foil to any off-label promotion that’s out there," Fassett, who is also a pharmacist, declared.

In the case of United States of America v. Alfred Caronia, a jury in 2008 found Caronia, a drug company’s specialty sales consultant, guilty of conspiring to introduce a misbranded drug into interstate commerce.

The drug in question was Xyrem, a product of Orphan Medical Inc.

Xyrem’s labeling originally listed one indication for use: treatment of cataplexy in patients with narcolepsy.

FDA approved a second indication on November 18, 2005: treatment of excessive daytime sleepiness in patients with narcolepsy.

According to the 2nd U.S. Circuit Court of Appeals’ review of the case, a physician cooperating with the government twice audio-recorded Caronia promoting Xyrem for uses not mentioned in the FDA-approved labeling.

The physician had posed as a prospective Xyrem customer during a federal investigation of Orphan and another physician the company had hired to promote the drug through speaker programs.

In the audio recordings, Caronia had stated the then single labeled indication before naming several off-label indications. He also described the labeled patient population before mentioning an off-label patient population.

Whether any of Caronia’s oral promotions about off-label uses were false or misleading was not an issue raised by the government, the appellate judge writing the majority opinion pointed out.

Fassett said the judges’ majority view, since no evidence suggested Caronia had said anything false or misleading, was that "simply making a true statement can’t be a crime."

In summation and rebuttal in the district court, the government "identified Caronia’s speech alone as the proscribed conduct," the appellate judge for the majority wrote. And in instructions to the jury, the district court had reinforced the idea that promotional speech by itself was enough to support a verdict of guilty.

Fassett said the appellate judges decided the case in part on the basis of those instructions.

The judge who wrote the majority opinion stated that the government’s stance—that the Food, Drug, and Cosmetic Act’s provisions against misbranding make it a crime for drug companies to promote off-label uses—"is content- and speaker-based, and, therefore, subject to heightened scrutiny."

For physicians and academics, the judge offered as examples, the government’s stance on speech about off-label uses is different.

Fassett suggested that the judges might have reached a different decision on the case had the government sought civil, not criminal, damages.

The majority decision on the case, he said, was "somewhat predictable based on some recent trends in federal jurisprudence" concerning commercial speech, which is protected by the First Amendment.

He referred to three cases, all of which were decided by the U.S. Supreme Court:

  • In 2011, the court affirmed the 2nd Circuit’s decision on Vermont’s Prescription Confidentiality Law. The law’s intent to prevent drug companies from using data on physician prescribing habits for marketing prescription drugs restricted commercial speech on the basis of speaker and content without justification.
  • In 2002, the court affirmed lower courts’ decision on the Food and Drug Administration Modernization Act of 1997. The law’s provisions prohibiting pharmacies from soliciting prescriptions for and advertising compounded drugs placed unconstitutional restrictions on commercial speech.
  • In 1980, the court reversed a lower court’s decision on a New York Public Service Commission’s regulation. This regulation banned electric utilities from promotional advertising designed to stimulate the demand for electricity. The Supreme Court decided this restriction on commercial speech was broader than necessary to advance the state’s interest in energy conservation.

The 2nd Circuit, responsible for cases in Connecticut, New York, and Vermont, issued its decision on United States v. Caronia on December 3, 2012—two years after hearing the arguments.

Orphan Medical pleaded guilty in 2007 to one felony count of misbranding a drug, and parent company Jazz Pharmaceuticals Inc. agreed to pay $20 million in "penalties and victim compensation," according to the Justice Department.

Jazz reported in a financial filing that a former regional sales manager and the physician who was a speaker for Orphan Medical each pleaded guilty to a misdemeanor charge.

The 2nd Circuit’s ruling, Fassett said, does not affect FDA’s guidance on industry-supported educational activities.

Nor does the ruling alter the False Claims Act, he said.

Under the act, according to the Justice Department, the federal government recovered nearly $2 billion in fiscal year 2012. Most of that money came from GlaxoSmithKline LLC to resolve several allegations, including promotion of five drugs for off-label uses.

 

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