by Christina Sandefur
Federal regulations not only block patients from making treatment choices; they have taken away the tools patients and doctors need to make informed choices. Earlier this week, I wrote about how under federal law, pharmaceutical companies can be charged with a crime simply for telling a doctor about a legal, alternative use for an approved treatment, even though that information could help improve – and even save – people’s lives. Today, I spoke at the Cato Institute about the consequences of this FDA gag rule, and how we can overturn it. I was joined by Howard Root, former CEO of a medical device company who was the target of a 5-year criminal prosecution for simply speaking the truth, Dr. Jessica Flanigan, an assistant professor who teaches ethics at the University of Richmond, and Michael Cannon, director of health policy studies at the Cato Institute.
So-called off-label treatment – treatments used for conditions, patients, or dosages other than what the FDA approved that medicine to treat – is legal, but the government routinely censors pharmaceutical companies—which know the most about their drugs—from sharing information about legal off-label uses of their products.
Howard Root told the story of how he found himself the subject of a federal criminal prosecution over the truthful words spoken by a few of his company’s salespeople about an FDA-cleared medical device that constituted only 0.1% of the company’s sales and never harmed a single patient. After a five-week criminal trial wherein the government’s case was so weak that the defense didn’t even call a single witness to testify, the jury returned “not guilty” verdicts on all charges. But the damage had been done. Because even a single guilty verdict would have excluded Vascular Solutions from selling any of its medical devices in the U.S. and sent Howard to prison for years, the ordeal required a defense team of 121 lawyers fighting for five years at a cost of $25 million.
Although he was fully vindicated, Howard decided to sell Vascular Solutions and retire rather than continue to assume the risks of running a medical device company under the FDA’s gag rule. He spends his retirement speaking out against prosecutorial misconduct and chronicled his experiences in a book, Cardiac Arrest: Five Heart-Stopping Years as a CEO on the Feds’ Hit-List. At today’s event, Howard said that since he started telling his story publicly, he gets emails all the time from people facing the same problem. Sadly, many are forced to plead guilty to these charges, even though they’ve done nothing but share truthful information about lawful treatments, because they can’t afford the type of legal defense that Howard was able to employ.
Next, Prof. Jessica Flanigan argued that the FDA’s censorship policies are immoral, because it is a violation of an individual’s fundamental right to medical autonomy for the government to censor truthful speech about medicine. Ignorance can be deadly, and the censorship of truthful information about medical treatments can cost lives. After all, the FDA isn’t the expert about what is best for a patient, given that person’s needs: The patient is. Whether a drug is acceptably risky is not a medical or a scientific judgment – it is a normative judgment that may vary from person to person. That’s why public officials cannot effectively determine whether the risks of a drug outweigh the benefits, as all people have different values in addition to different medical conditions. And that’s why prohibitions on off-label speech ultimately harm the people they’re intended to help – by depriving them of the information they need to make an informed decision. Rather than ensuring that physicians and patients know what they need to know to make their own decisions, the government has become the decision maker, limiting what people can say, restricting what doctors can prescribe, and dictating what patients can take—all because it thinks it knows what’s best for us. Jessica outlines these and more philosophical arguments for patients’ freedom of choice in her book, Pharmaceutical Freedom: Why Patients Have a Right to Self Medicate.
Finally, I argued that this censorship doesn’t just hurt patients; it violates the constitutional right to free speech. Yet companies are subject to criminal penalties for communicating to doctors valuable and truthful information about lawful off-label uses for approved treatments.
The few courts that have directly addressed this issue have said that the Constitution protects a company’s right to share information about off-label uses. Unfortunately, the FDA has developed a disturbing practice of settling these cases or otherwise preventing the courts from making clear just when and how drug companies can share information. In fact, after the Second Circuit said in U.S. v. Caronia that truthful off-label speech is protected by the First Amendment, the FDA literally ignored the ruling, saying it would not change the way the Agency prosecutes speech.
Despite myriad calls for reform, lawmakers haven’t come to the rescue. Over a year ago, the FDA introduced very modest (and ultimately, unhelpful) reforms in an effort to clarify its off-label policy. After several delays, the Agency announced it would postpone that proposal indefinitely. So long as Congress and the courts continue to allow the FDA to censor speech by medical experts about the legal use of legal medicines, they and their patients will suffer from the lack of clear standards regarding what information can be shared about treatment options.
Fortunately, states are stepping up to protect the rights of doctors and pharmaceutical companies to freely share research and information about legal medical treatments. The Free Speech in Medicine Act passed the Arizona legislature last year with unanimous, bipartisan support. This year, several states have already introduced similar bills, with more states to come.
Lawmakers in other states can—and should—follow Arizona’s example, restoring the right to freely exchange truthful information about legal treatments, and providing healthcare providers and payers with the tools they need to make informed healthcare decisions for patients.
Read more about how your state can protect free speech in medicine here.
Missed “Overturning the FDA’s Gag Rule?” Watch it here.
Christina Sandefur is Executive Vice President at the Goldwater Institute.