Fish Oil, Snake Oil, the FDA and the Courts

Brian Wolfman blogged yesterday about a Washington Post story pointing out that fish oil supplements are being marketed to consumers to lower the risk of heart disease despite the absence of scientific evidence bearing out their effectiveness. The FDA allows manufacturers of the supplements to get away with making a "qualified health claim" that "supportive but not conclusive studies" suggest that they will reduce risks of heart disease. In light of the current science described in the Post article, even that may be an overstatement. But, fearful of being sued for violating the First Amendment rights of supplement manufacturers, the FDA exercises "enforcement discretion" not to go after them for making that claim.

That's bad enough, but it gets worse. Amarin, the manufacturer of Vascepa, a prescription drug containing omega-three fatty acids derived from fish oil, now wants to make the same claim for the drug.

Vascepa is approved to treat extremely high levels of triglycerides that create a danger of pancreatitis, but that is a relatively limited market. Amarin wants to encourage doctors to prescribe it to patients with lower but still persistently high triglyceride levels that haven't come down when statins were prescribed to lower the patients' cholesterol. The problem is that the FDA refused to approve the drug for that purpose because of the absence of sufficient evidence that such treatment would actually reduce the risk of heart disease.

Amarin argues, among other things, that because supplement manufacturers get away with making the heart health claim for fish oil supplements, it must also have a First Amendment right to market its drug to doctors with the same claim. The advantage of marketing fish oil omega-threes as a prescription drug over marketing them as a supplement is obvious: Having a doctor prescribe a drug is, for many patients, a more persuasive selling point than having someone suggest they take a dietary supplement. Moreover, prescription drug sales are often underwritten by insurance, and prescription drugs often cost more than supplements. So marketing omega-threes as a drug for the same purposes they’re now marketed as supplements may considerably up the ante, and the potential rip-off of consumers.

The federal drug laws enforced by the FDA prohibit manufacturers from marketing a drug with the intent that it be put to an unapproved use, but Amarin says the First Amendment bars enforcing that prohibition against them if the FDA can't prove that what they say in marketing the drug is false or misleading. The Post article suggests that even a qualified claim for the efficacy of fish oil against heart disease may actually be misleading, but the FDA’s willingness to let supplement manufacturers make the claim puts the agency in a bit of a bind if it makes that argument here. In any event, the premise of the federal drug laws is that drug manufacturers should have to bear the burden of proving both safety and efficacy of a drug for its intended uses, not that they can sell drugs for any purpose unless the FDA proves they’re engaging in fraud.

Amarin is suing the FDA in the U.S. District Court for the Southern District of New York, and its request for a preliminary injunction was argued Tuesday. The legendary Floyd Abrams led the charge for the proposition that the First Amendment protects the right to market a drug for a use for which it hasn't been proved to be effective.

James Madison, is this what you had in mind?

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