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Free Minds & Free Markets

The First Amendment Applies to the FDA Too

Can the government prevent drug firms from telling patients true facts about the medicine they prescribe?

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Of course, even if the courts do eventually establish a clear and unambiguous precedent holding off-label promotion to be constitutionally protected, that need not keep the FDA and federal prosecutors from hounding drug makers. The feds know that under federal anti-fraud laws, even charging a drug firm with mislabeling is enough to disqualify the company from selling any products at all to federal health programs, such as Medicare and the Veterans Health Administration. Even if the charge is later dismissed due to its unconstitutionality, an indictment alone could cost the firms billions of dollars in lost sales while the case is being litigated.

When faced with a threat of prosecution and the likely loss of billions in revenue, most companies capitulate and agree to pay a hefty fine and to refrain from the perfectly legal and constitutionally protected activity of off-label promotion. There have been dozens of examples, including Allergan, which agreed in 2010 to a $600 million settlement to resolve a case involving the promotion of its drug Botox for treatment of chronic migraines before FDA review or approval of the drug for that indication; and Endo Pharmaceuticals' agreeing in 2014 to pay $171.9 million to resolve liability for off-label promotion of topical anesthetic Lidoderm.

Businesses that might have gone to court to clear their names and defend their First Amendment rights have chosen not to do so in order to avoid a criminal indictment that could cost their shareholders billions. That is, in effect, legalized extortion by the government.

Fortunately, a new head of the FDA, Dr. Scott Gottlieb, appears to have brought with him a new attitude about the legality of off-label promotion. In early January 2017, during the Obama administration's final few days, the FDA issued a rule on "intended uses" that reiterated its view that off-label promotion renders a drug or medical device criminally mislabeled. The incoming Trump administration put a hold on that and all other new regulations, choosing to implement some and reverse many others. The FDA's intended-use rule was among those chosen for additional review, suggesting that the new administration may not let it go forward—and may, in fact, rewrite the document to clarify what kinds of off-label promotion will be considered legal. A final decision is expected sometime this month, and many observers are optimistic that the agency will finally acknowledge that the FDA is not immune to the First Amendment.

The government should be able to regulate commercial speech to ensure it is not misleading or fraudulent, but the First Amendment's guarantees would be weak indeed if they did not protect the right to utter, hear, and promulgate truthful, non-misleading information. As the Supreme Court concluded in the landmark 2002 case Thompson v. Western States Medical Center, which involved advertising by pharmacists, "the First Amendment directs us to be especially skeptical of regulations that seek to keep people in the dark for what the government perceives to be their own good." That excellent rule surely suggests that some types of off-label promotion are protected speech.

Henry I. Miller, a physician and molecular biologist, is the Robert Wesson fellow in scientific philosophy and public policy at Stanford University's Hoover Institution. Gregory Conko is deputy director of the George Mason University Law & Economics Center.

Photo Credit: Charanlak Suwannate/Dreamstime.com

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  • SIV||

    the FDA treats it as misbranding or fraud

    I wish the FDA would treat eggless vegan "mayo" and lab-grown and plant-based "meat" as misbranding and fraud because that's what it fucking is. Don't get me started on fat-free "half and half" and "sour cream".

    Better yet, abolish the FDA.

  • SQRLSY One||

    Why don't sellers get creative here? Its not soy milk or coconut milk, it's soy miilk or soy mulk or coconut milck? As if consumers think that soy milk might be cow's milk in the first place, come ON!!! WHO is gonna get confused if we label it "Vegan Mayo"? But then"vegan Mayu" to bypass the fuck-heads at the FDA should help! Come on, sellers, get creative!

  • Azathoth!!||

    the problem isn't labeling it 'Vegan Mayo', the problem is labeling vegan mayo 'Mayo'

  • BestUsedCarSales||

    I think this is easily handled by people without any need of a government agency defining things.

  • Quixote||

    Just as long as we all agree that the First Amendment does not apply to criminal "satire," contrary to outrageous "opinion" pieces such as this:

    https://forward.com/opinion/385050/

  • mtrueman||

    "the problem is labeling vegan mayo 'Mayo'"

    We are blessed to live in a time and place where folks can say this, in all seriousness, without embarrassment.

  • Griffin3||

    I don't see what the problem is. Look at the crap Kraft has been marketing as "Sweet and Sour" sauce for years.

  • SQRLSY One||

    Well, ya know, we have to have Government Almighty PROTECT us all from ignorant consumers, who might casually glance at the big fat label on a product, ignoring the finer print... And then WHO KNOWS WHAT might happen!

    Suppose, for instance, that I see a "Soy Milk" label, and then assume that the cows have been drinking or eating "Soylent Green", to make this milk... And "Soylent Green is PEOPLE", ya know, and then I might panic, pick up some guns, take revenge on the supposedly-people-eating "mad cows", shooting up the cows, and THEN who knows what would happen after THAT?!?

    Maybe "cows take revenge", as in "Cows with Guns", see https://www.youtube.com/watch?v=FQMbXvn2RNI ...

  • SQRLSY One||

    Here we are, more than a year after Trump takes power and is supposedly "cleaning out the swamp", and absolute CRAP like this ain't fixed yet?!?! WTF?!??!

    Some bright young genius needs to bypass Government Almighty, and put up a web site for doctors and pharmaceutical companies. Post up instructions on this web site, for computer weenies to see how to use TOR or TunnelBear or other VPNs to post content. Police the content a tad... And locate the server in Iceland or other nation away from USA snoops and power-piggies and thought-control police... Iceland has a LOT of this kind fo freedom, I think...

    And invite ANONYMOUS sources (like, inside sources at pharmaceutical companies, as well as doctors) to post content, to include white papers and PDF files, ALL about off-label uses. One killer web site for this, that is power-pigs proof, would ROCK!!!. I bet they could sell advertising for pharmaceutical companies, at the same time as they accept anonymous donations of content, from "leakers"! Wikileaks leaks a lot of stuff about other stuff; WHERE is our web site for "leaks" about pharmaceuticals?!?!?!

  • Robert||

    It's called Medline.

  • WoodChipperBob||

    "Here we are, more than a year after Trump takes power and is supposedly "cleaning out the swamp", and absolute CRAP like this ain't fixed yet?!?! WTF?!??!"

    I'm guessing you missed the second to last paragraph, where it said, "In early January 2017, during the Obama administration's final few days, the FDA issued a rule on "intended uses" that reiterated its view that off-label promotion renders a drug or medical device criminally mislabeled. The incoming Trump administration put a hold on that and all other new regulations, choosing to implement some and reverse many others. The FDA's intended-use rule was among those chosen for additional review, suggesting that the new administration may not let it go forward—and may, in fact, rewrite the document to clarify what kinds of off-label promotion will be considered legal. A final decision is expected sometime this month," Cleaning out the swamp actually takes time, if you want to avoid throwing a whole lot of babies out with the bath water. And while I'm not convinced that the Trump administration really intends to clean out the swamp, I haven't seen any evidence that they don't.

  • C. S. P. Schofield||

    ""the FDA exaggerates its overall place in the universe,""

    Why should it be any different from any other government agency?

  • Frank White||

    The most powerful off-label drug info I know: Want to avoid heart disease? Drop the statin and take low dose Viagra.

  • Ben of Houston||

    I have to say that I can't fully stand behind this.In fact, I believe that it is taking precisely the wrong tactic.

    Why? Airborne. A compound that is demonstrably useless, makes billions of dollars a year through what is essentially fraudulent advertisement. Homeopathy, a "science" that is essentially peddling of magic potions, runs rampant. People are being actively defrauded here.

    The restrictions on advertisement of medicine to what has been actively proven is a strong protection of the people. The problem isn't the ability to publish uncertain results. It's the FDA's ludicrous standards that make it a Herculean feat to prove water is wet. Reduce these to reasonable standards of evidence, and you can have the protection of the people without enabling the snake oil salesmen.

  • Robert||

    But the Homeopathic Pharmacopoeia of the US is included statutorily as among "official drugs", largely because US senator Royal was a homeopathic physician. FDA's just doing what Congress says.

  • Robert||

    As usual, I don't fault FDA in this, but Congress & the courts. (It'd be the same at the state level were cases to come up there.) Nearly all regul'n of classes of products by state & federal gov't is based on intended uses of the products, which inextricably ties restrictions on marketing to communication. As bad as it is concerning off-label use of drugs, what about the many products which FDA or att'ys gen'l go after as misbranded drugs of medical devices which aren't labeled for medical use at all? There it's all about inferences of unstated but supposedly intended uses. Lawmakers have long treated off-label use as a loophole by which a marketer can slyly get around all sales restrictions, effectively vitiating the restrictions & their supposed consumer protection entirely—for what would stop someone from marketing a product in the knowledge that it would be used as a drug (or any other regulated product class) without getting the product licensed as a drug (etc.) at all, putting no instructions on the label? Eventually 3rd-party payers would catch up to that new reality, doing their own research on the effectiveness of products.

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