Free ‘Commercial Speech’ Cases Threaten Pharmaceutical Regulation

Justin Karter
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Two recent court rulings argue that pharmaceutical companies have a first amendment right to market drugs “off-label” with a lack of scientific evidence, threatening to weaken the FDAs regulatory power. In an editorial in this month’s JAMA Internal Medicine, attorney Amy Kapczynski provides an update on the legal battle between the FDA and the pharmaceutical companies fighting for the freedom of “commercial speech.”

Kapczynski recounts how the pharma company Amarin Corporation attempted to have its omega-3 fish oil supplement Vascepa approved by the FDA for a broad base of patients with cardiovascular disease. Vascepa had only been approved for patients with very high triglyceride levels, and the FDA voted 9 to 2 to disapprove its use in a wider population. This sent Amarin’s stock price plummeting, and the company faced lawsuits from investors.

supreme court
The FDA may have to take its regulation of “off-label” drug marketing to the Supreme Court

Amarin responded by suing the FDA, “arguing that the First Amendment gives the company the right to market its drug for this broader group of people despite the lack of regulatory approval and the lack of evidence of an outcomes benefit for patients.” Current standards require that pharmaceutical companies present evidence to the FDA to gain approval for a new use of a drug, but the argument made in this case “hit at the heart of the drug regulatory system in the United States.”

“Amarin argued that this system is unconstitutional, and that companies should instead be allowed to market their products in any way that a judge would consider to be neither false nor misleading.”

In August, the judge in the district court of Manhattan agreed with the company and ruled that they could market their drug in the desired broader population. He also ruled that the company could make specific claims about the drug that the FDA had called misleading, namely that “supportive but not conclusive research” shows that the drug “may reduce the risk of coronary heart disease.”

The ruling was based in large part on a 2012 case, US v Caronia, where a Federal Court of Appeals for the Second Circuit held that “truthful and non-misleading” statements made to promote a prescription drug off-label were protected by the First Amendment right to free speech.

Caronia is the name of a sales rep, Alfred Caronia, who was pushing the drug Xyrem (also known as the date rape drug). The FDA has approved Xyrem for very limited uses including narcolepsy, but Caronia suggested that it was “a very safe drug” that could be utilized for Parkinson’s, fibromyalgia, chronic pain, chronic fatigue, insomnia and weight loss in patients as young as eight and over sixty-five. Remarkably, the court ruled that these statements were not “false or misleading.”

If the Amarin ruling holds, Kapczynski writes, it “has the potential to unleash a flood of misleading marketing to physicians.” Under the ruling, a company would only have to convince a judge, rather than the FDA, that it is not making “false or misleading” claims.

Kapczynski points out a major flaw in this system: we are replacing drug regulators, with expertise and access to data and data analysis tools, with judges- “whose expertise in science and medical research varies considerably.” In the same vein, the judge in the Amarin case is reported to have commented, “You’re talking to somebody who has difficulty using a toaster.’ “I’m the last person who should opine on this.”

“If the decision stands, companies with a drug approved for one use will have to produce only enough evidence to convince a judge, not the FDA, to market it for additional indications.”

The FDA has yet to appeal the Caronia or Amarin decisions, signalling that it may not be confident of its treatment in the higher courts. At some point, however, Kapczynski believes that the FDA will have to take this issue to the Supreme Court.

 

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Kapczynski A. Free Speech and Pharmaceutical Regulation—Fishy Business. JAMA Intern Med. Published online February 01, 2016. doi:10.1001/jamainternmed.2015.8155. (Extract)

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16 COMMENTS

  1. “If the decision stands, companies with a drug approved for one use will have to produce only enough evidence to convince a judge, not the FDA, to market it for additional indications.”

    I wonder if this could lead to fights among the pharmaceutical companies competing for market share if they start taking each other to court to convince judges not to allow marketing for additional uses.

  2. The members of the FDA need to review the history of why that branch of government was created in the first place, particularly its purpose and goals. I would also encourage them to read policy & procedure manuels, and review job descriptions each signed as a commitment to the public safety. Just look at the FDA watchdog and see how important you are as our advocate. Big Pharma has been undermining your authority for way too long!!! Your superiors tell you to look the other way or hit the highway. Once this Pandora’s box is opened, vitamins, herbs, energy pill and drimks, Please take the Moral high ground .

    • Obama selecting a Big Pharma ally to the exe post at the FDA is not going to change this situation with Big Pharma any time soon. I could imagine seeing that kind of link that the FDA might take on the challenge of the competition from the natural remedies industry though. With Big Pharma in the natural remedies business, the situation gets altogether more complex. Ominously, brand name affiliation begins to sound like a current presidential candidate.

  3. “arguing that the First Amendment gives the company the right to market its drug for this broader group of people despite the lack of regulatory approval and the lack of evidence of an outcomes benefit for patients.”

    The FDA has approved Xyrem for very limited uses including narcolepsy, but Caronia suggested that it was “a very safe drug” that could be utilized for Parkinson’s, fibromyalgia, chronic pain, chronic fatigue, insomnia and weight loss in patients as young as eight and over sixty-five. Remarkably, the court ruled that these statements were not “false or misleading.”

    Soooo snake oil salesmanship is now legal? I should totally start my own company. I’ve got some grass clippings that can relieve sunburn, shrink brain tumors, and cure cancer. Only $500 per blade. Get in fast because at these prices they’ll be flying off the shelf.

  4. If doctors can prescribe medications off-label without any evidence, why shouldn’t companies market them on the same basis? It doesn’t make sense that doctors can legally prescribe anti-psychotics to two year olds but companies can’t encourage them to do it. The public should come to accept the fact that neither the FDA, nor their doctors, nor the pharmaceutical companies are effective guarantors of the safety or efficacy of substances that they put in their bodies – caveat emptor. I don’t see the current pharmaceutical regulatory regime as being particularly effective. Public health would be better served by open efforts to crowdsource information on drugs and their effects under real-world conditions, that people could access and use to make their own risk assessments.

  5. Does this make the drug companies the main source of evil in the U.S., or would that be the courts? “Whenever the roles of individuals within a group become specialized, it becomes both possible and easy for the individual to pass the moral buck to some other part of the group. In this way, not only does the individual forsake his conscience but the conscience of the group as a whole can become so fragmented and diluted as to be nonexistent… The plain fact of the matter is that any group will remain inevitably potentially conscienceless and evil until such time as each and every individual holds himself or herself directly responsible for the behavior of the whole group –the organism-of which he or she is a part” (People of the Lie; The Hope for Healing Human Evil by M. Scott Peck, MD, pg. 218)