In a potentially landmark ruling, the US 2nd Circuit Court of Appeals has reversed a lower court's finding that a pharmaceutical sales representative was guilty of promoting off-label uses for certain approved drug products, finding that the government's actions had violation the man's right to free speech.
Many analysts questioned whether the ruling could eventually lead to a sea change in the way drug promotion is conducted in the US.
Currently, companies are not allowed to market a drug for any purpose not explicitly approved by the US Food and Drug and Administration (FDA). For instance, if a drug-say, Viagra-obtained approval for its cardiovascular benefits, the company-Pfizer-would not be able to market its uses for erectile dysfunction without first obtaining approval from FDA.
The 3 December 2012 court ruling seems poised to overhaul the status quo. Writing for the court, Judge Denny Chin said that the government cannot stifle free speech to advance a questionable public good. "The First Amendment directs us to be especially skeptical of regulations that seek to keep people in the dark for what the government perceives to be their own good," Chin wrote.
"The government clearly prosecuted [sales representative Alfred] Caronia for his words-for his speech," the court added. "A pharmaceutical representative's promotion of an FDA-approved drug's off-label use is speech," it added, citing Sorrell v. IMS Health, a 2011 Supreme Court case involving pharmaceutical marketing data.
"The Sorrell Court held that "[s]peech in aid of pharmaceutical marketing . . . is a form of expression protected by the . . . First Amendment. . . . [The] creation and dissemination of information are speech within the meaning of the [Constitution]," the majority argued. If that interpretation is upheld by the Supreme Court in the case of an appeal-almost certain given the gravity of the case and the passionate dissent of the minority opinion-off-label pharmaceutical marketing may soon be difficult for FDA to legally restrict.
One of the biggest problems identified by the court in regards to the government's position on free speech was the inequity between doctors and company representatives. If a doctor is allowed to discuss-and even prescribe-products for off-label purposes, they argue, so too should a sales representative, so long as the promotion is not misleading.
Another problem identified by the court relies on the government's interpretation of the Federal Food, Drug and Cosmetic Act (FD&C Act).
"While the FDCA makes it a crime to misbrand or conspire to misbrand a drug, the statute and its accompanying regulations do not expressly prohibit or criminalize off-label promotion," the court wrote. "Rather, the FD&C Act and FDA regulations reference 'promotion' only as evidence of a drug's intended use. Thus, under the principle of constitutional avoidance, explained infra, we construe the FD&C Act as not criminalizing the simple promotion of a drug's off-label use because such a construction would raise First Amendment concerns."
In other words, a sales representative's promotion of a study about an unapproved use for a drug is not necessarily promotion because it is not proof of intent.
And because the government's case almost entirely relied upon the fact that the defendant simply promoted the drug (for purposes for which it was later approved), it needed to meet a four-part scrutiny test established under a 1980 court case, Central Hudson Gas and Electric Corp. v Public Service Commission, in order to prohibit the sales representative's speech.
In that case, the majority said free speech for commercial entities is permissible if it is not misleading or regarding illegal activity-the first part of the four. The government, meanwhile, must prove three things: that it has a substantial interest in regulating the speech, that it can do so in a way narrowly tailored toward achieving its goal, and that it can advance the government's interest to a "material degree."
The sales representative's speech satisfied the first component on the Central Hudson case while the government failed to meet the latter two components of the same test, the court wrote, undermining the government's case and giving them cause to vacate the sales representative's conviction.
NY Times - Ruling Is Victory for Drug Companies in Promoting Medicine for Other Uses
Pharmalot - Free Speech: Off-Label Conviction Overturned
Reuters - Court voids drug rep's conviction, cites free speech
WSJ - Conviction Overturned in Drug-Marketing Case
Bloomberg - U.S. Barred From Prosecuting Off-Label Sales of DrugsFDA Law Blog - In Landmark Ruling, Court Reverses Conviction Involving Off-Label Promotion