By Christina Sandefur
May 10, 2018
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. 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 federal government routinely censors pharmaceutical companies—which know the most about their drugs—from sharing information about legal off-label uses of their products. This information could help improve—and even save—people’s lives.
It wasn’t always this way. Federal drug regulations focused at their inception on ensuring that products marketed to the public were safe and correctly labeled, so that patients had truthful information to make informed decisions for themselves. But over time, rather than empowering patients and doctors, the government has become the decision-maker, because government thinks it knows what’s best for us.
That 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.
That’s why I’m thrilled to have worked with the Federalist Society to release this paper today, which addresses why the federal gag order on off-label speech is not only bad policy—it’s unconstitutional.
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.
The paper highlights these decisions and explains how 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 with unanimous, bipartisan support and is being considered in other states nationwide.
The new Federalist Society paper calls upon the FDA to follow the states’ lead and once and for all declare that truthful and non-misleading communications about off-label uses of approved treatments are permissible.
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.”
Christina Sandefur is the executive vice president at the Goldwater Institute.