Around the world, counties with restrictive regulations over health care are facing shortages of ventilators, hospital beds, and testing kits. America should take a different approach —one that opens our health care system to innovation, and empowers doctors, nurses, and medical researchers to save more lives.
One area ripe for reform: The Food and Drug Administration. The FDA has stood in the way of innovation, but we are already seeing ways that embracing innovation can save lives:
- Medical researchers are rapidly developing testing that can confirm an infection in less than an hour—after the FDA reversed its previous ban.
- Innovators are making promising new drugs available much faster—after the FDA lifted unnecessary rules that have nothing to do with patient safety.
- Congress should make permanent FDA’s current, temporary relaxation of its Emergency Use Authorization (EUA) rules for infectious disease tests, not only with respect to coronavirus but also infectious diseases generally. Specifically: allow decentralized testing as the standard approach, allow test analysis by private and state labs without requiring centralized permission, allow in-home sample collection using tests that are safe and unlikely to produce excessive numbers of false negatives (for example, samples drawn with a finger-prick), and allow privately manufactured and non-FDA approved tests.
The FDA needs to lift more regulations. We are calling on lawmakers to reform the FDA to unleash American innovation and save lives.