Last August, the U.S. District Court for the Southern District of New York decided that the Irish drugmaker Amarin, manufacturer of the triglyceride-lowering drug Vascepa, could tout the drug’s apparently beneficial effects on a wider class of patients than what the U.S. Food and Drug Administration had approved. The wider benefit has not been demonstrated by full FDA trials, but Amarin has sufficient experimental evidence of that benefit, the court ruled; informing health care providers of those results would be truthful and non-misleading speech in accordance with First Amendment court decisions involving “commercial speech.”

Though doctors already could prescribe Vascepa to those patients as an “off-label use,” Amarin (and other drug companies with products having off-label benefits) wasn’t allowed to discuss such use with either doctors or patients. In the District Court’s opinion, that prohibition “paternalistically 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.”

Amarin follows a seminal 2012 Second Circuit Court of Appeals decision, U.S. v. Caronia, vacating the 2008 conviction of pharmaceutical sales representative Alfred Caronia. (The Second Circuit includes the Southern District of New York.) Caronia had promoted the Jazz Pharmaceuticals drug Xyrem, FDA-approved for treating narcolepsy, as also effective for treating insomnia, fibromyalgia, and other maladies. There is scientific evidence supporting those off-label uses, but the FDA has not granted approval for them. Because he gave that information to health care professionals, Caronia was convicted of violating the Food, Drug and Cosmetics Act (FDCA), but he appealed on free speech grounds. In finding for Caronia, the Second Circuit concluded, “The government cannot prosecute pharmaceutical manufacturers and their representatives under the FDCA for speech promoting the lawful, off-label use of an FDA-approved drug.”

The FDA decided not to appeal Caronia’s victory, fearing that a loss before the U.S. Supreme Court would extend the Second Circuit’s ruling nationwide. The U.S. Justice Department and state attorneys general have repeatedly used the threat of prosecutions like Caronia’s to wring billions of dollars in settlements, fines, and civil damages from drugmakers (e.g., $2.3 billion from Pfizer in 2009, $1.4 billion from Eli Lilly in 2009, $1.6 billion from Abbott Laboratories in 2012, $3 billion from GlaxoSmithKline in 2012, $2.2 billion from Johnson & Johnson in 2013), and didn’t want to risk the loss of that cash cow. But now the drugmakers are seizing on the Second Circuit decision to block future extractions; Amarin’s suit is just the first of what should be vigorous drug industry pushback.

Amarin’s effect / In Amarin, the Justice Department argued that the drugmaker’s appeal was a “frontal assault” on the FDA’s drug approval regulatory framework. If Amarin’s arguments were adopted by the court, claimed the government, then pharmaceutical manufacturers would skip the FDA approval process for new uses (“indications” in medical jargon) of an FDA-approved drug.

The Amarin court was unmoved by this argument. It noted that the Caronia decision offers an “alternative, less speech-restrictive means for the FDA to achieve its objectives” of protecting public health and safety, and that the Justice Department had elected not to petition for certiorari or seek an en banc review of Caronia (which was decided by a three-judge panel). If the FDA truly believes that cases like Caronia and Amarin are a threat to its duty to protect the public, it hasn’t made much effort to combat that threat, the court reasoned.

Going forward / The FDA and Justice Department are now likely weighing two courses of action: (1) appeal Amarin, and (2) encourage drugmakers to voluntarily work with the FDA even though they have growing freedom to promote non-FDA-approved uses. Those actions are not mutually exclusive, and interestingly both could benefit consumers—but not the federal government.

Concerning an appeal of Amarin, the FDA and Justice Department are now in a similar position to where they were following Caronia. They could elect not to appeal, allowing the decision to stand in the Southern District of New York and have a circumscribed effect on the pharmaceutical industry’s prescription drug marketing and advertising efforts. Or they could appeal, but the case would go to the Second Circuit—an unwelcome prospect for the government. So a decision to appeal would likely be a choice to go all the way to the U.S. Supreme Court, which has of late been receptive to First Amendment claims by corporations.

A loss at the Supreme Court would mean the FDA would lose a big chunk of its nationwide regulatory authority over off-label marketing and advertising.

A loss at the Supreme Court, of course, would mean the FDA would lose a big chunk of its nationwide regulatory authority over off-label marketing and advertising of pharmaceuticals. The FDA would still have authority to investigate and enforce civil and criminal remedies against untruthful and misleading commercial “speech.” But a loss on appeal would significantly reduce the number of billion-dollar criminal and civil settlements by the Justice Department against pharmaceutical companies who honestly promote off-label uses of their drugs. That would be a loss for the government—but, of course, a big win for both the pharmaceutical industry and consumers.

What of voluntary cooperation between drugmakers and the FDA? The Amarin court recognized that its decision does weaken the need for the FDA’s approval process for a new pharmaceutical indication (but obviously does not impinge on the need for an original indication to be approved). Perhaps in an effort to “split the baby,” the court recommended that drug manufacturers submit to the FDA the “speech” that they intend to use in promotional material and adverting for a non-approved use, along with an explanation for why the “speech” is truthful and non-misleading.

This idea had previously been advanced by the drug industry’s chief trade association, the Pharmaceutical Research and Manufacturers Association (PhRMA). In its 2008 Guiding Principles on Direct to Consumer Advertisements about Prescription Medicines (2008), PhRMA recommended:

Companies devote substantial time and effort, and often ask for input from FDA, to ensure that DTC [Direct to Consumer] communications are accurate, fairly balanced, and meet all applicable legal requirements. PhRMA member companies will engage in a dialogue with FDA to maximize opportunities for FDA review of DTC advertising prior to release, consistent with these Principles and the Agency’s priorities and resources.

This cooperation could be a benefit to consumers and drugmakers while giving the FDA some input into off-label marketing. If the agency truly has expertise in identifying clear and accurate marketing language, the manufacturers and their customers should welcome that expertise to their marketing efforts. Drugmakers and consumers would retain the important freedom to communicate with each other about new, scientifically supported uses for already approved drugs, while the FDA could improve that communication’s quality.