WLF backs Allergan off-label suit

Share this article:
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.
Share this article:
You must be a registered member of MMM to post a comment.

Email Newsletters

MM&M Future Leaders


Register now

Early bird $1,950 before 31 October 2014

*Group discounts available on request 

MM&M EBOOK: PATIENT ACCESS

Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.

More in Features

Read the complete October 2014 Digital Edition

Read the complete October 2014 Digital Edition

Click the above link to access the complete Digital Edition of the October 2014 issue of MM&M, with all text, charts and pictures.

Predicting your pink slip

Predicting your pink slip

Any time a firm needs to save money, high-salaried executives are targets

Private View: New ways to engage with customers

Private View: New ways to engage with customers

These healthcare social media campaigns successfully use emotion, altruism and the human desire to "brand" oneself to get customers engaged.