Washington Legal Foundation (WLF) and three patient advocacy groups have filed a friend of the court brief in the District of Columbia federal court supporting a request by Allergan for a preliminary injunction to block the FDA from enforcing regulations and policies prohibiting the company from providing information to healthcare providers on an off-label Botox.
Allergan's complaint and request for injunction says that it is not seeking to communicate with consumers, but wants to give healthcare providers safety data on using Botox to treat spasticity in certain patients.
Allergan says that providing such information to healthcare professionals is against FDA regulations and federal government policies and makes a company vulnerable to criminal prosecution and civil penalties. The company claims that such policies and regulations violate the First Amendment's free speech provisions and are inconsistent with the Federal Food, Drug and Cosmetic Act.
The WLF brief says that the Allergan suit “squarely presents the question whether the First Amendment permits the federal government to ban truthful, accurate and non-misleading speech to physicians regarding off-label uses of FDA-approved prescription drugs.”
It notes that the importance, prevalence and value of off-label uses are well known to healthcare professionals.