While the COVID-19 pandemic has created unforeseen challenges for the American healthcare system, it has also created innovative opportunities for long-overdue healthcare reform. Lifesaving treatments are on the horizon—but they’re tied up in mounds of red tape preventing rapid delivery. The U.S. government and the 50 states must make reforms to get these treatments quickly to Americans who need them most.
A new report out today from the Goldwater Institute provides a blueprint for dismantling the obstacles that stifle innovation, so that patients will get rapid, informed, and high-quality care. In Putting Patients First: Unleashing Innovation in American Healthcare, Goldwater lays out a plan for reforming the healthcare system—with model legislation that we will pursue in all 50 states and at the federal level to help make reform into reality.
The Goldwater Institute has long been a champion of expanding and protecting individual liberty by working in courthouses, statehouses, and communities. Many know the Institute for our landmark Right to Try law, which upholds the principle that you—not the government—have the right to decide to pursue potentially lifesaving medical treatments. Passed in 41 states and signed into federal law in 2018 with overwhelming bipartisan support, Right to Try ensures that the government does not get a veto stamp over a lifesaving treatment when it is available and recommended by your doctor. And today, Right to Try is saving lives.
But our work isn’t done. Now is the time to super-charge Right to Try and move the needle toward truly patient-centric healthcare. Although it lacks the authority to regulate the practice of medicine, the U.S. Food and Drug Administration (FDA) continues to wield enormous power and influence over our healthcare decisions—usually with little or no accountability. Science and technology aren’t standing in the way of getting cutting-edge treatments to patients; bureaucratic rules and red tape are.
But there’s hope. During the COVID-19 crisis, we witnessed how removing red tape accelerates the availability of treatments and vaccines. The Goldwater Institute’s plan builds upon these important lessons, relies on important research and scientific advances, and continues to embrace important protections for vulnerable patients—all while expanding and respecting medical autonomy. The result is a package of practical reforms that expands healthcare freedom and unleashes the future of medicine.
Some of the reforms proposed in our plan include:
- Safeguard the right to try cutting-edge medicine by expanding Goldwater’s Right to Try law so that Americans can benefit from personalized treatments that use information about that person’s own genes and particular disease.
- Remove the secrecy from the U.S. drug approval process by shining a light on how the FDA chooses who gets access to treatments—so that Americans aren’t left in the dark about how the agency makes life-or-death decisions.
- Empower patients with information about access to lifesaving treatments by directing the National Library of Medicine to accept and include information about medicines available under Right to Try on ClinicalTrials.gov.
- Ensure doctors have information about cutting-edge treatments by allowing drug manufacturers to share truthful and scientific information about “off-label” treatments.
- Bring the world’s leading medical treatments to Americans by providing an expedited pathway for these treatments in the United States.
- End “expert panels” that keep treatments from the most vulnerable—so that patients in need don’t receive outdated or inadequate treatment based on the arbitrary value placed on their lives by a government “expert.”
- Allow states to approve tests and protective equipment during times of national or state declared emergencies—so that the United States can truly be world-class in its provision of needed testing and equipment to its patients and medical professionals.
- Ease the pathway for compounding pharmacies to serve patients by limiting the FDA’s discretion over requiring new approval for existing medicines and limit the FDA’s overbroad interpretation of its authority—so that patients don’t face enormous treatment costs.
- Open the door for stem cell treatments and regenerative medicine by modernizing and simplifying the regulatory structure for these innovative treatments.
The reforms in the Goldwater Institute’s plan move us closer to the important goal of bringing the right treatment to the right patient at the right time. And they do so in a way that remains faithful to the tenet that the government shouldn’t stand in the way of patients who are under their doctor’s care and trying to save their own lives.