Drug Company Suing FDA Over Right to Discuss Off-label Uses


The New York Times reported on a lawsuit against the FDA by Amarin, the manufacturer of a prescription omega-3 fatty acid derivative. The company wants the right to tell physicians about benefits of its drug which the FDA has not approved.

“If you tell the truth — if you’re not misleading — then the First Amendment protects you when you provide this sort of information,” a lawyer for the company told the Times.

But a representative of Public Citizen said, “The First Amendment right is not an absolute right. It has limits. And it’s always been subject to a balancing test. If this lawsuit were to succeed, it would be devastating for drug safety and undermine the drug approval process.”

Drugmaker Sues F.D.A. Over Right to Discuss Off-Label Uses (New York Times, May 7, 2015)


  1. This suit by Amarin is a stalking horse for what lies ahead. The FDA ITSELF has put forth two draft guidances that would let the pharmaceutical industry exagerate the benefits of a drug and downplay its risks – thus totally neuterizing FDA labels, all under the guise of “free speech”. It is up to the Administration to trash or approve these moves by the industry- influenced FDA. Secretary of HHS Sylvia Mathews Burwell has these proposals on her desk.
    Also in the wings is a nightmare bill called the “21st Century Cures” Act, introduced into the House by Rep. Fred Upton – he has taken more pharma money in campaign contributions than any other member of the House. Among other things, the bill will restructure the way the FDA reviews and approves drugs and medical devices as well as raise drug prices even higher.
    If you think the FDA is a paper tiger now, wait until one or both of these stick.
    If you care about prescription drug safety at all, these issues are pretty critical, according to Public Citizen.

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  2. “undermine the drug approval process”

    How in the world can they ‘Undermine’ a process that’s little more than in your face, million dollar plus per approval, PDUFA bribes?

    “it would be devastating for drug safety”

    What drug safety? Look at the U.S, Govt’s decision/non-intervention regarding the Free Speech Rights of drug co. sales reps.


    Side Effects? We don’t care if you just make it up as you go to make the sale.

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