A First Amendment debate has been brewing in the pharmaceutical industry.
It deals with the question of whether it’s OK for drugmakers to tell doctors about other conditions their medication may treat — even if it hasn’t been officially approved by the government’s chief drug regulator, the Food and Drug Administration.
On Tuesday, the drug company Amarin Corporation settled its case with the FDA. The settlement, which upholds a district court ruling from August 2015, gives the company the ability to provide “truthful and non-misleading speech” promoting off-label (meaning not approved by the FDA) use of their Vascepa capsules, a prescription form of the Omega-3 fatty acids found commonly in fish oil.
Jim Stansel, a partner with Sidley Austin and the former acting general counsel of the US Department of Health and Human Services (of which the FDA is a part) says the settlement is important for two reasons.
First, it draws on the First Amendment’s protection of free speech, since the agency is allowing drugmakers to provide off-label information so long as that information isn’t deceptive.
“What it does recognise — and what it shows that the FDA is sort of forced to recognise — is that there is a place for truthful, non-misleading information that is off label,” Stansel told Business Insider. “It’s encouraging in the sense that the FDA has sort of been forced to recognise that there is a place for that kind of a conversation.”
In this case, Amarin successfully defended its right to provide doctors with information grounded in scientific evidence. While the medication in question is not officially approved to treat a certain disease, they do have some scientific evidence which suggests it’s at least somewhat effective at treating that disease.
The case is also a good example of a bigger issue: The delay between clinical trials, which can take anywhere from a few months to a number of years and result in getting evidence of how safe and effective a certain medicine is, and federal approvals, which adds even more time, and results in either approval or denial based on how strong that evidence is.
“I think as long as you have a system where you’ve got this delay between clinical trial results and approvals, you’re always going to have this period where there’s more information out there than there’s actual backing from an official stamp from an FDA kind of perspective,” Stansel said.
The settlement allows drugmakers to tell the full story of a drug, complete with positive and negative outcomes, so that doctors can come to informed conclusions about whether their patient would benefit from using the drug under a faster timeframe than if the drug had to meet every regulatory validation, a process that could take years.
Still, the settlement doesn’t establish the legal framework that Stansel thinks would be necessary for this to start happening frequently. “It certainly doesn’t go so far as to make a policy,” he added.
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