How the FDA is Blocking Truthful Information from Getting to Doctors and Patients

July 25, 2018

Food and Drug Administration (FDA) regulations are preventing patients and doctors from accessing the most up-to-date information concerning treatment options. In a new video from the Federalist Society, Goldwater Institute Executive Vice President Christina Sandefur explains that these “off-label” speech regulations restrict the way drugs, biologics, and medical devices are marketed and labeled.

“Even though the treatments are legal, the FDA prohibits pharmaceutical companies from sharing truthful information about those off-label uses with doctors, with insurance companies, and with patients,” Sandefur says. “Why would the FDA want to prohibit the exchange of information that is perfectly truthful?”

“Off-label use” refers to the prescription of a drug or medical device for purposes other than what the FDA approved it for. Although off-label prescriptions are legal and account for about one fifth of annual outpatient prescriptions, the FDA limits the information companies can provide about off-label usage. Indeed, people who share this information – even if it is truthful and helpful – can be charged with a federal crime. These harsh penalties have a chilling effect on pharmaceutical companies, who are not able to share the most up-to-date information about effective legal treatments.

“Lack of information can be deadly,” Sandefur warns. “If pharmaceutical companies aren’t able to freely share the most cutting-edge, up-to-date information that they have—and only they have—about treatments, then those people who are making decisions that affect a person’s life will never be able to make decisions in the most informed way.”

Not only is this restriction on speech hurting patients, but it violates the constitutional right of free speech. “Branding is a form of speech,” Sandefur says. “After all, it is just speech that is used to sell a product or an idea in exchange for money.”

While FDA regulations are at the heart of this problem, state lawmakers can enact reforms to help ensure that physicians have the most up-to-date and truthful information concerning treatment options. These state reforms should:

• Allow for truthful and non-misleading information to be shared between manufacturers and healthcare providers, whether it is solicited or not;
• Allow manufacturers to communicate with payers (who may be more inclined to cover treatments).

Arizona and Tennessee have already adopted these critical protections, providing doctors with the tools they need to make informed healthcare decisions with patients. To learn more visit: https://www.goldwaterinstitute.org/article/restoring-free-speech-in-medicine/