May 8, 2015 — An Irish drug-maker has filed a lawsuit against the FDA claiming that its rights to free speech are infringed because they cannot promote their fish-oil pill for “off-label” uses, according to the New York Times.
In most circumstances, doctors are allowed to prescribe a medication for any purpose they see fit. However, it is illegal for drug-makers to encourage doctors to prescribe a drug for any use that has not been specifically approved by the FDA.
The drug-maker, Amarin Pharmaceuticals, markets a fish-oil pill called Vascepta. It is only approved for patients with extremely high levels of triglycerides. Amarin wants to promote Vascepta for patients with lower levels of triglycerides.
According to Amarin, their right are being violated because they “may not freely communicate truthful and non-misleading information about Vascepa to health-care professionals … without fear of criminal prosecution and civil liability.”
In 2012, U.S. courts overturned the criminal conviction of a sales representative who promoted the narcolepsy drug Xyrem for off-label purposes, ruling that off-label speech was protected under the First Amendment so long as it was truthful and not misleading.
According to Reuters, the lawsuit states that the prohibition “severely restricts medical professionals’ access to information from the source most knowledgeable about the drugs: the drug manufacturers.”
Since 2009, drug-makers have paid $13 billion in fines for illegally marketing medications. Most of those fines involved off-label marketing, according to Forbes.
Last November, Johnson & Johnson was ordered to pay $2.2 billion for off-label marketing, including the powerful anti-psychotic drug Risperdal in children with disorders like ADHD. The company is now facing hundreds of lawsuits involving gynecomastia, a disfiguring side effect.
Three years ago, GlaxoSmithKline (GSK) paid $3 billion for marketing several drugs off label. One of those drugs, Zofran, was promoted to pregnant women with morning sickness. It has since been linked to higher rates of birth defects in several studies.
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