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Does Constitution Prevent FDA from Regulating Off-Label Promotion?

First Amendment challenges to the FDA’s off-label promotion ban are hardly novel, however case law in this area remains relatively unsettled. Drug makers initially rejoiced with the ruling in Washington Legal Foundation, however the case was later vacated.  Case law now appears to be more settled in the wake of Caronia.

First amendment contests are usually brought as either defenses to off-label prosecutions (as in Caronia) or by advocacy groups and drug companies seeking injunctive relief (Washington Legal Foundation).

What Caronia Settled

In Caronia, the U.S. filed a criminal case against Mr. Caronia, a pharmaceutical sales representative at Orphan Medical. Accused of promoting Xyrem off-label, Caronia was indicted on charges of conspiring to misbrand the drug. In response, Caronia asserted that the misbranding provisions of the Food, Drug and Cosmetics Act infringed upon his First Amendment right to commercial speech. The court, however, found no First Amendment violation, upholding the constitutionality of the FDA provisions.

What is interesting about Caronia is its resemblance to Washington Legal Foundation. Applying essentially the same analytical framework, Caronia upheld the misbranding provision’s constitutionality, while WLF came out differently.

Caronia and Washington Legal Foundation Compared

Washington Legal Foundation I evaluated the constitutionality of the 1997 FDA Guidelines governing the dissemination of journal and reference publications by drug makers to physicians concerning off-label uses. Washington Legal Foundation, an advocacy group supported by many drug companies, filed the injunctive action in U.S. district court in the District of Columbia.

The court held that the Agency’s Guidelines did indeed violate the First Amendment, on the grounds that the regulations were overly extensive.  In its opinion, the court cited various alternative, less burdensome solutions. While the decision was later vacated, the case established several key principles:

•    Off-label promotion is considered speech, not conduct
•    As such, it is subject to First Amendment scrutiny
•    Since it is commercial speech, the Central Hudson test governs

The distinction between Washington Legal Foundation and Caronia lies within the the fourth prong of the Central Hudson test – the “reasonable fit” requirement. While WLF found that the 1997 Reprint Guidelines were overly burdensome, the Caronia court did not find the misbranding provisions of the FDCA to be too extensive. Rather, the court deemed the misbranding provision “essential to adequately preserving the New Drug Application approval process.”

Simply put, the cases hinged on the possibility of viable alternatives to the contested regulations. The WLF court agreed with Washington Legal Foundation that mandatory disclosures were a viable, and less burdensome alternative to reprint guidelines and restraints. However, the Caronia court flatly rejected the alternatives proposed by Mr. Caronia as being ineffective and difficult to administer.