by Jon Guze
Senior Fellow, Legal Studies, John Locke Foundation
Earlier this month, the US District Court of the Southern District of New York announced its decision in Amarin Pharma, Inc. v. FDA. As healthcare economist John Goodman reports in Forbes, this is “a victory for free speech and common sense” that could improve American’s access to life-saving drugs:
Once a drug has been approved for one use, it is very common for researchers to discover it has other, unapproved uses. For example, more than half the cancer drugs doctors prescribe are “off-label.” They are being used to treat a condition other than the use for which they were originally approved.
Although doctors are free to prescribe any drug for any purpose, according to the FDA drug companies can only communicate uses for a drug that have FDA approval. Communicating off-label uses is a crime.
It’s also a crime that the FDA pursues rigorously. Take the case of Alfred Caronia, a pharmaceutical sales representative. In 2012, he was convicted after being caught on tape talking to a doctor about off label uses for the narcolepsy drug Xyrem. But a Manhattan federal appeals court tossed out the conviction, ruling that as long as Mr. Caronia’s speech was truthful and not misleading, it was protected by the First Amendment. …
All that appeared to change last Friday, when a federal district judge in Manhattan said that the FDA could not prohibit the truthful promotion of a drug for unapproved uses because doing so would violate the protection of free speech.
You would think this issue would be a no brainer. But serious people line up on the other side. Jerry Avorn, a professor at Harvard Medical School, wrote a commentary titled “In Opposition to Liberty: We Need a ‘Sovereign’ to Govern Drug Claims” in the Annals of Internal Medicine in June.
Yet this is exactly what the founding fathers rejected. We don’t need a sovereign to discover truth, according to Thomas Jefferson and his colleagues. The surest way to the discovery of truth is a free market in ideas.
The founders may have rejected the policing of speech, but, as the New York Times Reports, the FDA has a powerful incentive to go on doing it, and the ultimate disposition of this case remains uncertain:
There is a good chance the F.D.A. will appeal. … Over the last few years, the government reached major criminal and civil settlements with GlaxoSmithKline ($3 billion), Abbott Laboratories ($1.5 billion), Merck ($950 million) and Amgen ($762 million) related to off-label promotions of their products.
Nevertheless, the Times gives us reasons to be hopeful:
That appeal would go to the United States Court of Appeals for the Second Circuit, however, and the conclusion in the Caronia case that the First Amendment protects truthful statements about off-label drug use will be difficult to overcome, especially when there is no evidence of fraud or other deception by Amarin. Pursuing the issue to the Supreme Court may also present substantial hurdles for the F.D.A.’s regulation of off-label marketing. The justices have been receptive in the last few years to First Amendment claims by corporations, as the decision in Citizens United v. Federal Election Commission shows, so they may well side with companies that want to make truthful statements about their products.