FDA Policy on “Off Label” Use Causes First Amendment Fight

August 19, 2015

After being accused of “misbranding” their product, Amarin Pharma, a pharmaceutical company that manufacturers Vascepa, a cardiovascular health drug, recently challenged the FDA after promoting the product for an “off label” use, according to the Agency.

“Off label”, which is defined as “the use of pharmaceutical drugs for an unapproved indication or in an unapproved age group, dosage, or route of administration,” can apply to both prescription and over the counter (OTC) products. If a company desires to promote their product for a something that is not the FDA-approved intended use, then additional clinical trials must be conducted and approval must be obtained before promoting the use to doctors.

As such, Amarin conducted an FDA-approved study, which showed that the drug was effective in treating the off label use, but the agency denied approval. Amarin is now claiming that FDA’s rules regarding off label promotion are unfair and violate their right to free-speech, as stated in the First Amendment. The outcome of this statement? The company asked the district court to block any enforcement action, and the judge agreed, saying FDA’s rules and regulations regarding off-label marketing and promotion have too many incongruities.

However, while the First Amendment does protect speech that is true, it does not support or protect fraudulent speech. In the past, there have been courts that have rejected challenges to FDA’s off-label promotion requirements, but they have typically involved charges of fraud for mislesding doctors and the agency about the use of the product(s) in question.

It is more than likely that the FDA will appeal the decision of the district court, taking it to the US Court of Appeals for the Second Circuit, however we will just have to wait and see what their next step is and what results from those actions.

Making sure you are only promoting your FDA-approved product in ways that comply with the intended use(s) can be challenging and can sometimes get a little tricky. We have experience helping our clients comply with the FDA’s rules and regulations regarding off label promotion and advertisement of their products. For more info on how we can help you ensure and maintain compliance, please contact us


October 13, 2015

Can Consumers Handle More Quantitative Info in TV Ads? FDA Plans to Find Out…

FDA wants to know how much of the information presented in television advertisements consumers understandGem, and how much more information they could handle. In an effort to answer these questions,...

June 13, 2017

FDA Warns OTC Manufacturer After Finding Inaccurate Information in Product Listings

On Thursday, June 1st, the FDA issued a Warning Letter to Prestige Brands Holdings, an over-the-counter (OTC) drug manufacturer. PediaCare Children’s Plus Multi-Symptom Cold and PediaCare Children’s...

March 24, 2018

FDA Issues Final Rule to Delay Implementing Parts of ‘Intended Use’ Regulation

On Friday, March 16th, the FDA published a notice in the Federal Register, stating that the effective date for the amendments related to intended use would be delayed indefinitely. In the notice, the...