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Will the FDA Get Off-Label Back on Track?

May 7, 2018

By Naomi Lopez and Christina Sandefur
May 7, 2018

Too often, doctors are unaware of treatments that are lawfully available. It is not because doctors refuse to learn about them; it is because the U.S. Food and Drug Administration generally prohibits pharmaceutical companies from sharing information about “off-label” uses with doctors and insurers.

About one in five prescriptions in the United States is “off-label,” meaning the medicine has been approved for use by the FDA, but the doctor prescribes it for a different purpose, patient population, or dosage than the FDA approved. While doctors can legally prescribe off-label (and the practice is quite common), companies can face criminal prosecution and penalties from the FDA for “misbranding,” or communicating about off-label uses for a product outside of a narrow and often murky set of federal requirements.

Put simply, the government is censoring the communication of valuable information that could help improve—and even save—people’s lives. And these speech restrictions not only undermine patient care but they also violate the free speech protections in the federal and state constitutions.

But that is changing. Last year, Arizona became the first state to adopt the Free Speech in Medicine Act, a new state law, passed unanimously out of the legislature, that restores the right to freely exchange truthful information about legal treatments and provides healthcare providers and payers with the tools they need to make informed healthcare decisions for patients.

Just last week, similar legislation was signed into law in Tennessee after unanimously passing both of their chambers. This year, several more states have introduced and are drafting similar bills.

And according to a recent media report, Washington may follow suit. The FDA has commenced a First Amendment working group that is examining if and how the FDA should respond to the court rulings holding that the Constitution protects a company’s right to share information about off-label uses.

As the Supreme Court put it forty years ago, “information is not in itself harmful . . . people will perceive their own best interests if only they are well enough informed, and . . . the best means to that end is to open the channels of communication rather than to close them.” This is especially true in cases where the underlying behavior being communicated—here, prescribing off-label treatments—is itself perfectly lawful.

Despite these rulings, the FDA has a track record of preventing the courts from making clear just when and how drug companies can share information, or ignoring the courts altogether. But Dr. Scott Gottlieb, who was appointed FDA Commissioner last year, has a history of supporting the decriminalization of off-label communications and may shift course from his predecessors. But if past proposals to loosen the agency’s iron grip on off-label speech are any indicator, the FDA would still have a long way to go to meet constitutional standards. In the meantime, censoring speech by medical experts about the legal use of legal medicines will continue to harm patients.

We live in the 21st century where the speed of medical advancement continues to accelerate. The idea that sharing information—which is readily available in almost every aspect of our lives—is somehow inconsistent with a physician’s ability to evaluate the evidence to make a treatment determination for his own patient is nonsense.

Policies that withhold and conceal truthful, scientific information are not only incongruous with modern technology, but they also keep important treatment decisions hidden from those practitioners who are in the position to effectively use them.

Naomi Lopez is the director of healthcare policy and Christina Sandefur is the executive vice president and litigator at the Goldwater Institute. They are co-authors of the 2017 study, Restoring Free Speech in Medicine: How state lawmakers can overcome FDA regulations that keep doctors and payers in the dark.



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