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