April 16, 2020
By Nathan Callahan
The ongoing COVID-19 outbreak has upended daily life for millions of Americans—and it’s left us wondering what can be done to mitigate this current situation and help prevent future crises. Earlier this week, the Goldwater Institute hosted a special teleforum featuring Goldwater President and CEO Victor Riches and Director of Healthcare Policy Naomi Lopez to discuss some of the policy prescriptions that could make a positive difference going forward.
Kicking off the teleforum, Riches noted that the Goldwater Institute’s focus and thinking surrounding COVID-19 focuses on three main questions: 1.) How do we get people back to work quickly to jumpstart the economy?; 2.) How do we provide better educational opportunities for families?; and 3.) What can we do to expedite treatments to patients in need? And at the forefront of each of these questions is the importance of getting rid of unnecessary rules and regulations at the state and federal levels to help the country recover more quickly from this crisis.
Looking at the impact of healthcare policy, Lopez noted that the Goldwater Institute’s Right to Try initiatives have been crucial in “getting the right treatment to the right patient at the right time.” Now federal law, Right to Try gives patients access to treatments that have been clinically tested, but not yet been given an FDA rubber stamp. For many individuals, Right to Try is critically important because “if you have a life-threatening illness, you don’t have a decade to wait” for a treatment that could save your life.
Additionally, the FDA bars drugs from being used in the United States that have been approved for use in other countries without going through a separate approval process with the FDA–despite the fact that other countries often have approval standards equivalent to ours. Unfortunately, Lopez said, there is “a lot of risk aversion” at the FDA that has stood in the way of international reciprocity, preventing patients from getting speedier treatment.
Just as important in the current crisis is the “off-label use” of FDA-approved treatments. There is currently no FDA-approved treatment for COVID-19, so doctors are turning to off-label treatments—ones approved for other conditions. Off-label use is a widely accepted and important practice in the medical world, Lopez explained: “If you have a life-threatening illness, you probably have an off-label treatment.” In fact, 20% of all prescriptions in the United States are off-label. However, while prescribing treatments off-label is completely legal, drug manufacturers are prohibited from giving truthful, scientific information about drugs that have not been FDA-approved. Riches noted that this is “a clear First Amendment violation— and something the Institute will continue looking into in the future.
Although the current crisis has highlighted many concerns regarding overregulation, the discussion did note that there have been promising—albeit temporary—regulatory reforms made during the COVID-19 pandemic that ought to become permanent when life returns to normal. Across the country, regulations regarding telemedicine have been loosened, as well as relaxation of laws preventing doctors from practicing across state lines. “This is good policy all the time,” Lopez said.
In the best of times, onerous regulations of the healthcare industry can be dangerous to the health of the public. In the worst of times, they are deadly. Legislation that puts pressure on the FDA to move more quickly in its approval process and adopt policies such as international reciprocity will save lives today and tomorrow.
You can listen to the full teleforum above.
Nathan Callahan is a Ronald Reagan Fellow at the Goldwater Institute.