The Department of Justice has prosecuted companies like Pfizer, Astra-Zeneca, Eli Lily, and Johnson & Johnson, and has levied billions of dollars in fines as a result of off-label promotion. Many of the pharmaceutical and medical device cases lawyers at Beasley Allen have handled over the years involved off-label promotion that led to serious injury and death. When a pharmaceutical company promotes a product for an “off-label” use, it means that the company has not demonstrated to the U.S. Food and Drug Administration (FDA) that the product is both safe and effective for that use.
In early August, however, Federal Judge Paul Engelmayer of the Southern District of New York ruled that under the First Amendment, pharmaceutical manufacturer Amarin could promote its drug Vascepa for a use that has not yet been approved by the FDA. Amarin sued the FDA and the Department of Health and Human Services seeking a preliminary injunction that would prevent the company from being prosecuted for making certain truthful statements about the drug. Specifically, Amarin wanted to be able to tell prescribers, among other things, that “supportive but not conclusive research suggests that omega-3 fatty acids help prevent coronary artery disease.”
Although the ruling was narrow and based on specific facts, we believe that it could lead to dangerous and unintended consequences for consumers since this multi-billion dollar industry is highly competitive and driven by the slightest edge a company can gain over its competition in the numbers of prescriptions written by physicians. Additionally, it is now possible that if the government were to prosecute a pharmaceutical company for off-label promotion, the government would have to prove beyond a reasonable doubt that the statements made by the company were false, whereas in the past, the burden was on the pharmaceutical company to demonstrate to the FDA that the product was safe and effective for its intended use. It is our hope that the FDA will appeal the ruling so that corporate greed doesn’t take precedence over patient safety.
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