Rulings Threaten FDA and States’ Ability to Regulate Drugs and Therapy

Two cases could trigger dramatic changes in the way medications and therapies are regulated.

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USA, New Jersey, Jersey City, Medical sales representative talking with doctor in office

Two cases could trigger dramatic changes in the way medications and therapies are regulated.

The legal arguments now wending their way through the courts could either seriously undermine— or dramatically boost—the ability of regulators to protect the public from dangerous medications and therapies.

On their face, the cases seem to share little in common.  In one, a panel of federal judges in New York overturned the conviction of a drug company representative for illegal sales practices.  In the other, a federal court in California issued an injunction against a new law that bans “gay conversion” therapy for teens, scheduled to go into effect in January. Both cases raise critical, and unresolved questions about the tension between free speech and health claims that are regulated by the federal Food, Drug and Cosmetic Act (FDCA).

In the New York case, Alfred Caronia, then employed by Orphan Medical, was caught on tape promoting one of his company’s drugs to doctors for uses for which it had not been approved by the FDA.  Known as Xyrem, the medication is approved to treat narcolepsy, a condition involving extreme daytime sleepiness that can put patients in potentially dangerous situations.  Caronia, however, touted its usefulness in treating insomnia and to address sleepiness related to the pain disorder fibromyalgia. While it is legal for doctors to use medications “off label” if they believe it is in their patients’ interest, it is not legal for pharmaceutical companies to promote such use because the FDA has not evaluated such practices for efficacy and safety.

But citing free speech concerns, two of the three appeals court judges in the Second Circuit quashed Caronia’s conviction.  They wrote that he had clearly been targeted for his speech, saying, “[T]he 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 Second Circuit was the first court to interpret the First Amendment in this way; previous courts had ruled in favor of the FDA and its legal right to prohibit such “misbranding” of drugs. While the government may request a rehearing, if the decision stands, it may question a key part of the FDA’s ability to regulate drugs, which currently relies on prohibiting companies from selling drugs “off label.”  Billions of dollars in settlements have been paid out by every major pharmaceutical company for violating these rules.

MORE: Pharma Behaving Badly:  Top-Ten Drug Company Settlements

For example, in July, GlaxoSmithKline agreed to pay $3 billion, the largest fine since the FDAC was passed in 1938, to settle cases related to off-label promotion of the antidepressants Paxil and Wellbutrin, and issues involving suppression of data about the risks related to the diabetes medication, Avandia.  And Pfizer, Johnson & Johnson, Lilly and Abbott have also agreed to fines of more than one billion dollars each since 2009.

With the Caronia decision, the legality of all of these fines—some of which have not yet been finalized— will be called into question.  As attorney John Fleder, who represented the FDA in the case when he worked at the Justice Department told the New York Times, “Most if not all of these cases have been based on a central premise: that it is unlawful for a company and one of its employees to be promoting a drug or a medical device off-label… And this decision hits at the heart of the government’s theory.”

The implications for patients and physicians are equally staggering.  If the FDA cannot bar drug companies from selling medications for unapproved uses, would corporations seek approval for any drug for more than one condition? The testing required to show that a drug is safe and effective for additional uses is laborious and expensive—and also has the potential of revealing that the drug isn’t safe or effective for that purpose. PhRMA, the trade group for the industry, told the Times it was “pleased,” with the ruling, saying in a statement that the group “believes that truthful and nonmisleading communication between biopharmaceutical companies and health care professionals is good for patients, because it facilitates the exchange of up-to-date and scientifically accurate information about new treatments.”

If the pharmaceutical industry can legally make claims about any approved drug without meeting data requirements, doctors and patients could easily fall prey to exaggerated or false claims that put health and even life at risk. And research on drugs for children, which requires separate approval, would likely grind to a halt. As the judge who dissented in the case wrote, “[T]he majority calls into question the very foundations of our century-old system of drug regulation.”

Meanwhile, in California, federal judges ruled on another question related to the regulation of medical speech.  In September, governor Jerry Brown signed into law a rule banning therapists from using practices that attempt to turn gay youth under 18 into straight people.  There is no research evidence suggesting that such tactics work and many teens who have been exposed to them report being traumatized; some have committed suicide.

On December 3, U.S. District Court Judge William Shubb issued a preliminary injunction against the ban, saying that it could prevent “a mental health provider from expressing his or her viewpoints about homosexuality” and otherwise unconstitutionally block free speech.  Shubb also took issue with the claims that attempts to change homosexuality cause harm, calling them “questionable and scientifically incomplete.”

The next day, however, District Court Judge Kimberly Mueller denied such an injunction in her court, writing, “The court finds there is no fundamental or privacy right to choose a specific mental health treatment the state has reasonably deemed harmful to minors.” This week an injunction was handed down by the 9th Circuit preventing the law from taking effect, which will escalate the legal battle over whether, like drugs, talk therapy can, or should be regulated in terms of its safety and efficacy.

So should the government have a right to determine what claims can be made by drug sellers and what types of techniques can be sold as talk therapy? As a healthcare consumer, I certainly hope so.

I don’t want drug companies to be able to push medicines to my doctors without first having to show the FDA that the drugs do what they claim on the label, and do it safely— and I don’t want to receive talk therapy that is not only ineffective but potentially detrimental, not to mention costly.

Few experts currently believe that the problem with our system of medical regulations is that pharmaceutical companies and therapists are too constricted in their ability to promote their products and make sales. Indeed, while the fines imposed for off-label sales sound massive, the Glaxo fee, for example, captured only 11% of the revenue earned from the sales in question.  There is also a great deal of alarm about the increase in medication use that followed the legalization of direct-to-consumer medical advertising, as more patients may be approaching their doctors with request for specific medications.

If off-label sales are legitimized, there will be even less incentive to collect appropriate risk and benefit data, which already varies depending on a drug’s uses.  The side effect profile that is acceptable for a cancer drug, for instance, would be very different if the same drug were being sold as a treatment for acne because of the way the drug is delivered and how long patients would likely be taking the medication.

And the situation with talk therapy is even worse. There is no FDA to approve or reject talk therapies for mental illness and no federal law even bans the use of corporal punishment as part of “therapy” for youth in states that allow it.  It’s still possible, for example, to sell “gay conversion” therapy to teens in any state other than California and states vary widely in the professional qualifications they require for providing therapy, even with youth.

Under the current system, drug companies are already free to publish data suggesting that off-label use of drugs may be beneficial in scientific journals; they can present such data at meetings and provide it to physicians upon request — they just can’t have their sales representatives suggest such uses to doctors or advertise them.

Similarly, people who oppose homosexuality are free to argue against it and to try to persuade their children not to engage in such behavior.  But California is attempting to draw the line and distinguish between such beliefs and what passes for clinical therapy by making it clear that such programs should not be labeled as therapy or be sold as such.

We’ve decided as a society that medicine is a specific context where the rules on speech are different from what they are elsewhere because of patients’ vulnerability in the face of unknown risks and benefits.  The courts should uphold laws that regulate what may be sold as medicine, whether it’s talk therapy or a medication.  The problem here may not be too much regulation, but too little.