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Discusses Women's Health

A couple of years ago, I was asked to give the opening address for a conference on anti-aging and regenerative medicine in Las Vegas. I was intrigued by the fact that there was a large organization devoted to the topic (they had over 8,000 members worldwide), that the organizers wanted to pay me a substantial speaker’s fee and hey, it was a weekend in Las Vegas! As many of you know, I’m quite orthodox in my approach to medicine and generally prescribe FDA approved medications. The title of my talk was, “on label, off label, grey label”. On label denotes a medication that is FDA approved for a particular medical disease or problem. Off label means that the medication is FDA approved for certain conditions but because the pharmaceutical company has not supplied sufficient data on its efficacy and safety for the treatment of a new or different disorder, it does not have FDA approval. “Grey label” refers to products that have no FDA approval. (The evidence for their safety and effectiveness was either not presented to the FDA for review or failed a review.)

I was therefore quite intrigued by an article written by professors from the Hopkins Blumberg School of Public Health, the University of Wisconsin Law School and School of Medicine and Public Health that appeared in last week’s JAMA, “The promotion of medical products in the 21st-century: off label marketing and First Amendment concerns.”

The authors began the article with news that few physicians were aware of… (Few of us read legal decisions unless they have to do with malpractice cases): On August 7, 2015 the Federal District Court blocked the FDA from enforcing restrictions on the marketing and promotion of off label use of a drug called Vascepa, manufactured by Amarin Pharma. The company wanted to promote its drug (an FDA approved form of omega-3 fatty acids made from fish oil) for reducing triglyceride levels. The FDA’s expert group rejected this request on the grounds that there is insufficient evidence that triglyceride reduction prevents cardiovascular disease. The FDA determined that the promotion would be misleading and that “the available evidence does not establish that reducing triglycerides with the drug reduces the risk of cardiovascular events in patients already treated with statins.” Amarin objected and sued on the basis that its representatives have a constitutional right under the First Amendment to promote the reduction of triglycerides even without compelling evidence of clinical value.

Basically they were challenging the US approach to drug regulation through the FDA. This agency is supposed to protect the public from adulterated and misbranded drugs. After the 1962 disaster with thalidomide, Congress established a law that the FDA must give approval to drugs whose safety and effectiveness for intended use are supported by data from “adequate and well controlled” clinical trials. According to the authors of this article, requiring companies to demonstrate this to the FDA has led to the development of many breakthrough medical products.

The article cites the fact that two other decisions in federal courts have suggested that the FDA’s authority is at odds with the modern interpretation of the First Amendment protection of commercial speech. In this latest decision, the FDA claimed that a ruling in favor of the company “would reflect a frontal assault… on the frame work for new drug approval that congress created in 1962.” But the judge responded that “drug approval framework predates modern First Amendment law respecting commercial speech.” The judge rejected the FDA’s language.

I know this sounds like legal quibbling. But so far the FDA has allowed physicians to make decisions based on independently verified information (we do read on-going research articles), rather than information of unknown quality from a self interested source. According to this article, the author is concerned that liberalizing off label marketing may lead companies to increasingly forgo key research that establishes the safety and efficacy of their products. Courts would then have to negotiate promotional language, not a body of medical experts. The FDA’s review of safety and effectiveness would be minimized, which could lead to inappropriate clinical care and undermine medical advancement.

So we return to the issue of legal decisions versus medical science. Should judges use the First Amendment to undermine FDA regulatory functions? I have to agree that once we do not have FDA assurance that a medication is effective and safe when prescribed for the condition we are treating, we skirt a medical (and legal) gray zone…

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