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Court Goes Down a Dangerous Path Finding That “Free Speech” Allows Drug Company to Talk “Off-Label”

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One of the issues that has come up again and again in prescription drug lawsuits is the fact that many pharmaceutical companies have promoted their drugs for off-label uses not approved by the Food and Drug Administration (FDA). Though doctors can generally prescribe medications as they see fit, it is illegal for manufacturers to promote their products as solutions for conditions other than those the FDA has officially stated that the medication is approved to treat.

The law is in place to ensure among other things that drugs have sufficient data behind them before being used in a large group of patients, to reduce the risk of serious side effects and/or of ineffective solutions. Critics have called on the FDA to step up its monitoring off off-label advertisements, to curb those that can be misleading to patients.

The issue has come up again in an interesting case currently proceeding in the Southern District of New York. Amarin Pharmaceuticals filed a lawsuit against the FDA in May 2015, stating that the administration’s interpretation of what constitutes “off-label” promotion would prevent the company from sharing truthful information about their fish-oil product with physicians, in a way that could affect patient care.

On August 7, 2015, U.S. District Judge Paul Englemayer issued a preliminary injunction preventing the FDA from interfering with Amarin’s promotion of the product at this time. The decision has many concerned, as it could open the door to other “off-label” promotions that could be very misleading for patients and physicians.

Amarin Fights FDA on Off-Label Restrictions

Amarin’s lawsuit appears to be a pre-emptive strike against possible increased regulation by the FDA. According to Reuters, the administration announced in May 2015 that they were holding a public meeting to address the issue of what pharmaceutical companies can say about off-label drug use, and whether current restrictions violate the right of free speech.

GlaxoSmithKline (GSK), for example, was fined $3 billion in 2012, partly for their activity in promoting drugs like Zofran (anti-nausea medication) for the off-label use of Zofran in pregnant women. The company did not have FDA approval to promote Zofran to pregnant women. The drug was approved only for treating nausea and vomiting related to surgery and cancer treatments. And this is just one example among many.

Amarin filed its lawsuit against the FDA in an effort to be allowed to say more about their prescription product “Vascepa,” which was designed to help lower high triglycerides. Amarin want to tell physicians and the public about a study in which the pills had a positive effect on heart disease, but since the FDA hasn’t approved the medication for that use, Amarin so far has been prohibited from doing so.

FDA regulations, Amarin stated, “are unconstitutional under the First Amendment (freedom of speech) or Fifth Amendment (restriction against vague laws)….” They looked to the court for permission to communicate to healthcare professionals the data from their clinical trial on the drug, as well as additional data from peer-reviewed scientific publications on the efficacy of omega-3 fatty acids.

Ruling Threatens to Bring Out the Snake-Oil Salesmen

The FDA is concerned about the judge’s decision in this case, as am I. It may create serious public health risks, subjecting patients and doctors to potentially misleading claims about drugs that could lead to health complications.

Dr. Michael Carome, of the watchdog group Public Citizen, stated in a press release that the decision “represents a major victory for Amarin and the pharmaceutical industry,” but warns that for patient and public health, “this outcome represents a dangerous loss that threatens to return us to the days of the late 19th and early 20th centuries, when snake-oil salesmen touted ‘remedies’ that were too often ineffective—and often dangerous.”