March 30, 2020
By Victor Riches
As the nation faces the unprecedented coronavirus health care crisis, Arizona’s innovative spirit and fidelity to our state’s constitutional protections has paved the way for us to have an outsized role in the way Washington is responding.
The Goldwater Institute’s years-long work on measures to remove regulatory barriers so Americans can get potentially lifesaving medical treatment holds particular relevance in this crisis. These Goldwater measures — Right to Try, and the Free Speech in Medicine Act — are based on the important goal of bringing the right treatment, to the right patient, at the right time. And they’re helping to guide the Trump administration’s response to the crisis.
At a coronavirus task force briefing this past week, the Trump administration highlighted the importance of Right to Try as a critical first step in speeding up the FDA’s approval process. The law protects the right of patients facing terminal or life-threatening illness to obtain and use cutting-edge medicines without asking first for government permission when a doctor has advised the treatment, and it opened the door for the critical innovation in treatment that Americans need in today’s crisis.
“Right to Try has been a tremendous success. People are living now who had no chance of living,” President Trump said during the briefing, explaining that the policy has provided hope and breakthrough treatment options that would have otherwise taken years to reach patients who would have run out of time before the treatment obtained final FDA approval years later.
The Right to Try concept, legislative strategy, and bill language were crafted at the Goldwater Institute’s headquarters office in Phoenix. In 2014, the Arizona Terminal Patients’ Right to Try Referendum, Proposition 303, was passed in the Grand Canyon State. Right to Try eventually passed in 41 states and became federal law in May 2018.
The law addresses the concern that the FDA’s bureaucratic drug approval process is too slow when lives hang in the balance. Right to Try works in tandem with the current FDA approval process to meet the immediate needs of patients facing life-threatening illness.
In that same briefing, the president touted chloroquine, an FDA-approved drug to treat malaria and arthritis, as a possible treatment for some COVID-19 symptoms. About one in five prescriptions is “off-label,” meaning the medicine is FDA-approved, but it is prescribed for a different use or dosage. While doctors can already legally prescribe off-label, federal law prohibits pharmaceutical companies from sharing information about off-label uses with doctors. As a result, doctors and patients may be unaware of alternative treatment options lawfully available to them; and, even if they are aware, the information may be dated.
As the U.S. looks to possible effective options to treat the virus, it is important that medical professionals know and understand the arsenal of options at their disposal—and there is a legislative solution for that. Goldwater’s Free Speech in Medicine Act protects the dissemination of truthful, scientific information about off-label uses of FDA-approved drugs. In 2018, the Arizona Legislature unanimously passed Free Speech in Medicine, which allows manufacturers to share truthful, scientific information about off-label uses of their FDA-approved treatments. Two states have now passed the law and more are expected to follow.
The coronavirus outbreak poses many trials for Americans, but fortunately, we have tools to help us meet these challenges. And our home state has been the incubator for these policies that will hopefully help to speed our recovery.
First appeared at Arizona Capitol Times.
Victor Riches is President and CEO of the Goldwater Institute and was an architect of the Right to Try legislative strategy.
