Federal court ruling paves the way for off-label promotion of fish oil product.

  • FDA’s historical position is that “off-label promotion” — the promotion of pharmaceutical products for unapproved uses — violates the Federal Food, Drug, and Cosmetic Act.  The underlying logic is that:  (1) drugs are misbranded when they fail to bear adequate directions for a lay person’s use; (2) prescription drugs cannot bear adequate directions for use by a lay person (as their use must be supervised by a health care provider); and (3) although a statutory exemption exists in the context of prescription drug labeling, the drug must have labeling that directs licensed practitioners to use the drug safely for all intended purposes.  Essentially, the promotion of a drug for an off-label use establishes a new intended use for which no adequate directions have been provided in labeling.  FDA and the industry have sparred over the issue of off-label promotion for years, with FDA holding firm to its restrictions and the industry asserting that the First Amendment permits more information to be shared.  Recently, Amarin (a pharmaceutical company) challenged FDA’s off-label promotional ban in federal court.  The company sought an injunction that would effectively permit Amarin to share efficacy data with doctors where the data support a therapeutic indication not yet approved by FDA.
  • In a groundbreaking ruling, a New York federal judge granted Amarin’s preliminary injunction and ruled that the company has a First Amendment right to provide doctors with truthful and non-misleading information about the drug’s efficacy in treating patients with “persistently high” triglyceride levels, as compared to the “very high” level specified in FDA’s approval.
  • The ruling marks the first time that a federal court has so expressly stated that off-label promotion warrants First Amendment protection.  FDA has 60 days to appeal the decision, but has not yet indicated its plan of action.  Although the lawsuit is fairly narrow and restricted to specific statements about one particular drug, it may have broad implications for the drug industry and could open the door to a major change in FDA’s historical authority to restrict off-label promotion.