FDA

Who Decides What a Drug Is For—The Manufacturer or the Government?

Court rules you can't convict a salesman for recommending a medicine to doctors for purposes the FDA hadn't approved

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The FDA is definitely against promoting the use of pills in making a Dagwood sandwich.

An interesting ruling in New York Monday questions whether the Federal Drug Administration has the authority to tell pharmaceutical companies for which uses their drugs may be marketed. Via The New York Times:

In a case that could have broad ramifications for the pharmaceutical industry, a federal appeals court on Monday threw out the conviction of a sales representative who sold a drug for uses not approved by the Food and Drug Administration. The judges said that the ban on so-called off-label marketing violated the representative's freedom of speech.

The 2-to-1 decision by a three-judge panel of the Court of Appeals for the Second Circuit in Manhattan addresses a long-running and costly issue for the industry, which has paid billions of dollars in penalties to the federal government in recent years after being accused of marketing blockbuster drugs for off-label uses.

In July, for example, the British drug maker GlaxoSmithKline agreed to pay $3 billion in fines, in part for promoting antidepressants and other drugs for unapproved uses; a month later, Johnson & Johnson announced that its pharmaceutical unit had reached a $181 million consumer fraud settlement with 36 states and the District of Columbia over its marketing of Risperdal, an antipsychotic drug.

The case involved a sales representative from a drug company caught promoting a drug used to treat narcolepsy for other conditions, such as insomnia and fibromyalgia. He was convicted in 2008 after being recorded discussing "unapproved" uses of the drug with a doctor.

There are some interesting complexities. According to Katie Thomas' reporting, while the FDA blocks the pharmaceutical industry from marketing the drug for other purposes, a doctor is allowed to prescribe a drug for whatever purpose he or she wants. So a doctor could legally prescribe the aforementioned drug to treat insomnia, but the company's salesperson wouldn't be allowed to tell the doctor it could be used to treat insomnia. The court ruled this violated the salesman's freedom of speech:

"The government clearly prosecuted [Alfred] Caronia for his words — for his speech," the majority wrote, concluding later "the government cannot prosecute pharmaceutical manufacturers and their representatives under the F.D.C.A. for speech promoting the lawful, off-label use of an F.D.A.-approved drug."

The case may go back to circuit court's full panel of judges for a rehearing, and then ultimately could be taken up by the Supreme Court.

(Hat tip to former Reason Editor Virginia Postrel)

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  1. (Hat tip to former Reason Editor Virginia Postrel)

    Remember how good the magazine used to be?

  2. Why can’t the user decide what a drug is for?

    1. Because the user does not own their own body. It is on loan from the prison system. Any unauthorized use will justify the body being returned to its rightful owner.

      1. ^^ This

    2. Because Fuck Wards of the state, that’s why.

    3. This is the correct answer.

    4. “Why can’t the user decide what a drug is for?”

      I did. Bought me 8 years. Fuck the FDA

    5. The user is allowed by current law to decide what a drug or medical device is for. That doesn’t mean it can be legally marketed with the claim it can be used for that purpose.

  3. That which is not explicitly permitted is forbidden.

  4. I’ve done consulting work for a law-firm that does this sort of prosecution, and having seen the underbelly of the beast up close, I have strong feelings about it.

    The problem here is the fucking patent of monopoly system (surprise surprise) + onerous drug approval regimes.

    Rather than drug manufacturers being paid by consumers only for things that work and being allowed to try and discard and tweak their products, they are channeled into making a few things, rewarded if they pretend those things are more effective than they actually are (even to the point of doing bogus trials to get their patents extended) and consumers are fucked over on overpriced half-baked “cures”

    R&D should be funded by groups like the Easter Seals as a charitable venture, and if the cure for MS happens to be a pill, then the cheapest pill-maker can get the fucking contract selling them for a couple of dollars per 100ct.

    1. “The problem here is the fucking patent of monopoly system government involvement and use of force in any capacity over someone’s medical decisions

      FTFY

    2. R&D should be funded by groups like the Easter Seals

      LOLWUT?

    3. Strong feelings

      1. Ugh… I can never remember which symbols will actually show up on the new comments system (which isn’t really new.)

        Anway, strong feelings are great but maybe next time you can pair them with coherent, feasible ideas?

  5. the company’s salesperson wouldn’t be allowed to tell the doctor it could be used to treat insomnia.

    Oh, I’ll bet a bit of this goes on:
    “You know, Doc, this can NOT ***wink wink*** be used to treat insomnia.”

  6. The line of free speech vs. fraud is hard to draw. Obviously, if a drug treats a problem, it shouldn’t be illegal to tell people about it. If a drug doesn’t treat a problem, it should be illegal to tell people that it does.

    But what does it mean to “treat”? Aye, there’s the rub.

    1. What do you mean? How is the line any less clear in the field of pharmaceuticals than it is, say, in automobiles, high tech, or foods? Why isn’t Apple told that it can only advertise iPads for “approved” uses to “protect” consumers from “fraud?”

    2. Here’s the line: if you say something, and somebody can demonstrate it was fraudulent, you’re liable. If they can’t, you’re not. Seems pretty clear to me.

  7. Between this decision and the unanimous Supreme Court decision in Arkansas Game & Fish Commission, it has not been a good day for Big Government.

  8. “the company’s salesperson wouldn’t be allowed to tell the doctor it could be used to treat insomnia.”

    Not telling a doctor everything there is to know about a drug sounds like a great idea to me! What could possibly go wrong?

  9. I haven’t read the decision, but my prediction is that if the prosecution appeals this, it will be reinstated. The reason is that if someone is allowed to sell a material in interstate commerce for a use not licensed by FDA, it doesn’t matter whether it’s already licensed by FDA for another use at all. “Off-label use” includes use of articles for any use they’re not licensed for; that is, it doesn’t matter whether it has an approved use or not. It would apply as well to totally unapproved drugs and medical devices as it would to those that are approved for other uses. And given that state & federal gov’t authority in that area is well established — predicated on regul’n of the commercial transaction accompanying the speech, not the speech itself — I don’t see a serious possibility of that being reversed here.

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