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What you need to know for 08/23/2017

Drug makers should only market medicines for approved uses

Drug makers should only market medicines for approved uses

Court wrong to allow so-called off-label uses

No one was saying that drug company sales reps were making up wholesale lies about alternative uses for government-approved drugs. But such claims would be possible, and the government wouldn’t be able to do anything about them, if this week’s ruling by a federal Court of Appeals in Manhattan is allowed to stand. It shouldn’t, and the government should appeal to the U.S. Supreme Court so it can’t.

At stake is nothing less than the public’s health. At issue is the right of drug sales reps to usurp the Food and Drug Administration’s authority by telling doctors that their products are effective in treating ailments other than the one(s) the FDA has approved them for. Although this is indeed the case with some drugs, the efficacy for all uses should be the FDA’s call — not the manufacturer’s or its sales rep’s.

Maybe the agency hasn’t tested a drug against a particular ailment, or maybe the tests were negative or inconclusive. If that’s so, the presumption has to be that the drug isn’t proper. It should only be promoted for its approved use, and any other considered fraudulent.

Interestingly, the argument that led to the 2-to-1 decision was made on First Amendment grounds: The drug rep caught in a sting discussing so-called off-label uses for a drug approved to treat narcolepsy claimed his free speech rights had been violated. But if the drug he was touting as a treatment for insomnia and fibromyalgia was really effective for those uses, then he (and his company) should get the FDA to say so. If they couldn’t advertise it on TV or in magazines for such uses (and that’s clearly the case), they shouldn’t be allowed to do so verbally, either.

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