The Federal Food, Drug and Cosmetic Act (“FDCA”) imposes specific requirements governing the approval, labeling and promotion of prescription drugs. FDA has exclusive authority to enforce those requirements.
The FDCA grandfathers out of the approval requirements products that were on the market before the statute was enacted. This exception recently created a conundrum for the federal district court in New Jersey, which addressed whether a plaintiff can sue under the Lanham Act claiming that the mere marketing of a grandfathered product, as the FDCA allows, falsely implies FDA approval. In Mutual Pharmaceutical Co., Inc. v. Watson Pharmaceuticals, Inc., Watson was selling a gout medication, which, it argued, was grandfathered. Mutual, unlike Watson, sought FDA approval to manufacture and sell the drug for gout, as well as the exclusive right to market it for a different, rare disease. Upon receiving FDA approval, Mutual, along with two other companies, sued Watson. Mutual alleged that by disseminating advertisements and product information through various channels, Watson falsely implied its drug was FDA-approved.
Watson moved to dismiss the complaint as a disguised effort to enforce the FDCA. Mutual’s claim, Watson contended, required the Court to determine an issue only FDA could decide -- whether Watson needed FDA approval to sell the drug. The Court disagreed. The question under the Lanham Act, the Court found, was not whether Watson needed FDA approval, but whether it falsely implied that it had FDA approval. The Court cited survey evidence in the complaint reflecting the inaccurate perception by consumers that FDA had approved the product. Interestingly, though, the survey dealt not with any advertising claims by Watson but rather with the belief by consumers that pharmacy computers would only display FDA-approved drugs. Watson argued that if marketing its product through traditional channels was sufficient to create the false implication of FDA approval, it could not market the product even though the FDCA allowed it to do so. Nevertheless, the court found that the facts as pled were sufficient to defeat the motion to dismiss.
This result --treating the mere marketing of an allegedly grandfathered drug as inherently misleading and subject to injunction-- is troubling. Arguably, such an injunction either would conflict with the FDCA where the Act did not require FDA approval for marketing, and would enforce the Act through a private right of action where approval was required.
Just how troubling the case is -- and how much latitude it affords for private claims -- is unclear. In an earlier case a California District Court declined to be drawn into what it viewed as enforcement of the FDCA. The plaintiffs in In re Epogen and Aranesp Off-Label Marketing & Sales Practices Litigation brought a RICO claim based on the defendants’ alleged off-label marketing of a kidney drug, in violation of the FDCA. The Court found that the “existence of federal enactments-i.e., the FDCA and accompanying regulations-making off-label promotion illegal, is central to many of Plaintiffs' claims . . . . Allowing Plaintiffs to proceed on a theory that Defendants violated RICO by engaging in off-label promotion, without specific allegations that Defendants made false or misleading statements, would, in effect, permit Plaintiffs to use RICO as a vehicle to enforce the FDCA.” In dismissing the complaint, the Court noted that the plaintiffs were free to bring claims based on wholly separable private causes of action stemming from the same activity.
To be sure, the artful tailoring of the complaint in Mutual Pharmaceutical, while sufficient to skirt a motion to dismiss, may not suffice to sustain the case beyond that stage. If plaintiffs do succeed, it will doubtless require substantial legal debate, not to mention further litigation, to determine where, between Mutual Pharmaceutical and Epogen, the balance tips from a separate, cognizable cause of action to an impermissible private effort to enforce the FDCA.
- Robert Weiner and Jessica Halbert
