Many manufacturers and industry watchers have recently renewed their challenges to the constitutionality of FDA’s expansive interpretation of off-label promotion on First Amendment grounds. Par Pharmaceutical Companies, Inc.’s recent lawsuit asked the courts to provide specific instruction and relief from prosecutorial threat for on-label communications to specific audiences who may also use their drug off-label. This is the latest in a series of attacks on the government’s aggressive stance on prosecution of pharmaceutical and medical device manufacturers and their executives for off-label promotion.
In addition to Par’s recent lawsuit, here are four more recent challenges:
- Allergan filed a similar suit in October 2009 alleging that the government’s actions to curtail truthful and non-misleading speech regarding off-label uses of its products violated the First Amendment. Allergan was forced to dismiss that lawsuit as part of its settlement of allegations related to off-label promotion of BOTOX® Medical in 2010.
- In June 2011, the Supreme Court decided in Sorrell v. IMS Health Inc. to strike down Vermont’s ban on the sale of prescriber data for commercial and marketing purposes. The Supreme Court interpreted the statute as an impermissible, back-door restriction on manufacturers’ constitutionally protected commercial speech. In the wake of that decision, many observers commented that the court’s reasoning in invalidating that law may apply with equal force to FDA’s position on off-label promotion.
- That theory that a manufacturer’s truthful, non-misleading speech regarding the off-label use of a prescription drug is entitled to First Amendment protection is being tested in United States v. Caronia, in which a sales representative is being prosecuted for off-label statements he made to a physician. That case is currently on appeal to the Second Circuit.
- In July 2011, a group of manufacturers filed a citizen’s petition asking FDA to provide detailed guidance for permissible off-label communications in the categories of:
- scientific exchange
- responses to unsolicited requests from health care providers and other customers
- communications with payers and formulary committees, and
- distribution of clinical practice guidelines developed by independent third parties.
The burden remains on manufacturers to scrupulously avoid activities placing them at risk for off-label promotion enforcement. However, these legal actions renew conversations which may alter the list of permissible and impermissible promotional activities in the future. At minimum, these actions may force FDA to more clearly articulate its expectations for industry.