SECOND CIRCUIT SLAPS DOWN FDA WITH FIRST AMENDMENT
On December 3, two of the three judges on a panel of the United States Court of Appeals for the Second Circuit agreed that FDA’s prohibition on off-label promotions of drugs violates the First Amendment to the United States Constitution in U.S. v. Caronia. The decision is a landmark First Amendment victory that establishes important precedent useful in attacking FDA censorship of health information generally. Judges Reena Raggi and Denny Chin were in the majority with Judge Debra Ann Livingston dissenting.
A drug sales representative, Alfred Caronia was convicted of conspiracy to introduce a misbranded drug into interstate commerce, a misdemeanor violation of 21 USC 331(a) and 333(a)(1). He promoted the drug Xyrem (containing the active ingredient gamma-hydroxybutyrate (GHB), illicitly used as a date-rape drug) for off-label uses. The drug was approved by FDA to treat narcolepsy patients who experience cataplexy (including symptoms of weak or paralyzed muscles) and to treat narcolepsy patients with excessive daytime sleepiness. An undercover federal investigation of Caronia revealed that he promoted the drug for the treatment of insomnia, fibromyalgia, periodic leg movement, restless leg, Parkinson’s, sleep disorders, muscle disorders, and chronic pain.
In its appellate argument, the government contended that Caronia’s speech was not directly in issue, a point belied by the record and the government’s arguments at trial, as well as by the jury’s instructions. The government tried to convince the panel that it did not seek to prohibit the content of Caronia’s speech per se but, rather, used that content as part of an “evidence of intent” analysis to conclude that the drug in question was misbranded and promoted without proper directions for use.
The Court rejected the government’s argument, explaining that it conflicted with the record below, and then proceeded to rely on the Supreme Court’s decision in Sorrell v. IMS Health, Inc., 131 S.Ct. 2653 (2011), which applied heightened First Amendment scrutiny to a Vermont statute that banned commercial use of prescriber-identifying information. The Court held the government’s prohibition on off-label use information unconstitutional not only under Sorrell but also under the long-standing intermediate scrutiny test applied to commercial speech, Central Huydson Gas & Electric Corporation v. Public Service Commission of New York, 447 U.S. 553, 563-564 (1980).
In particular, in assessing whether the prohibition on off-label promotions directly advanced the government’s interest (the third prong of Central Hudson), the Court wisely observed that the censorship actually had the perverse effect of interfering with “informed and intelligent treatment decisions.” The Court recognized that “[w]hile some off-label information could be misleading or unhelpful,” the case before it did “not involve false or misleading promotion.”
Critically, the Court reasoned that the government’s prohibition on off-label promotions did not directly advance the government’s ends because while FDA prohibits the promotions, it allows off-label prescriptions by physicians. “If the government’s objective is to shepherd physicians to prescribe drugs only on-label,” reasoned the majority, “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.”
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Finally, the Court found numerous, less speech restrictive alternatives to a ban on off-label promotions under Central Hudson’s fourth prong. Among those was to have the government alert physicians to false and misleading promotions, thus countermanding them with more speech rather than with a blanket ban on all off-label promotions (good and bad).
We may hear more on this decision if the Solicitor General chooses to appeal it to the Supreme Court at the behest of the FDA (a good bet). If it stands, the decision will form a new and powerful precedent to attack all manner of FDA acts of censorship of truthful health information, including nutrient-disease relationship claims and FDA’s de facto market ban on dissemination of literature containing nutrient-disease information.