May 8, 2015 — The New York Times reports that the FDA has been sued by a pharmaceutical company hoping to convince a federal judge that they have a First Amendment right to promote their medications for “off-label” uses.
Doctors are generally allowed to prescribe medications for whatever purpose they see fit, but federal law prohibits drug-makers from encouraging doctors to prescribe medications for anything except what the FDA has explicitly approved.
Amarin Pharmaceuticals, a small drug-maker from Ireland, sells a fish-oil pill called Vascepta that is FDA-approved to treat extremely high triglycerides — above 500 mg/dL — where other drugs can be used at about 200-mg/dL.
Last month, the FDA told Amarin they couldn’t promote Vascepta for patients with lower levels of triglycerides.
The lawsuit claims the FDA rule against “off-label” promotion “severely restricts medical professionals’ access to information from the source most knowledgeable about the drugs: the drug manufacturers,” Reuters reports.
Amarin also says its rights 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.”
According to Forbes, pharmaceutical companies have paid $13 billion in fines for illegal marketing practices since 2009, mostly for “off-label” marketing.
In July 2012, GlaxoSmithKline was ordered to pay $3 billion for illegal marketing, including the anti-nausea drug Zofran in pregnant women with morning sickness. There is now growing concern that Zofran may increase the risk of birth defects.
In November 2014, the Justice Department ordered Johnson & Johnson to pay a $2.2 billion fine for marketing several drugs “off-label,” including Risperdal in children. The company is now facing hundreds of lawsuits from young men who developed gynecomastia.
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