As is well known, drugs are approved by the FDA for specific uses. These are spelled out in detail on the label, and by label one means “package insert”, and more generally the FDA’s own regulatory language regarding what the drug has been cleared for. Companies spend a great deal of effort to get drug labels extended for new indications, and wrangle with the agency about the exact wording, because “off-label” promotion can lead to billions of dollars worth of fines. And has, several times. Keep in mind that (as in that example) whistleblowers from inside the sales and marketing organization are well-placed to alert the authorities if enough evidence piles up, and there are legal rewards in place for them if they’re successful.
But this entire system has been challenged over the last few years. In late 2012, a federal appeals court actually ruled that the FDA’s restrictions were illegal under the First Amendment, and that off-label promotion was protected commercial speech. This did not lead to a rush by drug companies into such behavior – they have well-paid legal counsel, too, and the advice (one infers) was to wait for the case law to stop bouncing around before making any big decisions. Earlier this summer, though, a company tried to force the issue.
Amarin is a small shop whose big product is a prescription fish-oil capsule, Vascepa. They have been trying for years now to get the FDA to expand their label, so that more physicians will prescribe their product and more insurance plans will pay for it, but the agency has been reluctant. Part of the problem has been that some recent clinical data have suggested that fish oil/omega-3 supplements don’t do as much for cardiovascular health as had been thought, although overall, the effect does seem to be positive. (The whole lipidology/cardiovascular disease relationship is undergoing some rethinking these days, which will be the subject of a different post). Amarin has been wanting to say that “supportive but not conclusive” research has shown that omega-3 supplementation is helpful, but the agency has been worried that this might lead some physicians (and their patients) to conclude that lifestyle changes and/or other therapies might not then be needed.
So Amarin finally sued them, on just the grounds of commercial speech mentioned above. On Friday, the judge agreed with them, granting a preliminary injunction saying that as long as the company is making truthful statements, the FDA doesn’t have the authority to stop them from doing so. His ruling was based on the 2012 decision, so if the eventual court case goes the same way, there would seem to be a pretty solid legal foundation for other companies to start pushing into this territory. That will move the entire relationship between the drug companies and the FDA towards “Are these statements truthful?” rather than the current “Did we tell you that you could say that?”
In theory, those two are already coupled, but not in practice. The scientific consensus keeps changing, and the regulatory agencies are not always known for their speed in these matters. Overall, as long as everyone knows what the rules are, I’m not necessarily upset by such a change. My biggest worry is that the definition of “truthful” might well encompass statements like “A recent study has shown. . .” when that recent study is actually poorly run, underpowered, etc. And there are plenty of those out there. And then there are the sins of omission: would it be truthful to cite a favorable study, but to gloss over the fact that there are equally valid-looking unfavorable ones? (I would say no, you have to refer to the whole landscape, but this is just the sort of thing that may well be fought out if things go in this direction).
And these, to be fair, are just the sorts of reasons that the FDA has traditionally advanced to justify its own regulatory restrictions. But it looks more and more like a new regime is coming, and they (and we) are going to have to get ready for it.
Update: here’s a review of past cases in this area, from Marginal Revolution, where Alex Tabarrok leans more towards the free-speech and less towards the regulatory-authority side.