Support the Verified Innovative Testing in American Laboratories (VITAL) Act, S. 1666
The initial response to the COVID-19 outbreak was dramatically hindered by layers of bureaucracy that prevented labs from using the tests that they developed. The bloated state of bureaucracy creates unnecessary challenges for medical professionals who are responding to public health emergencies.
The Center for Disease Control (CDC) prevented labs from conducting tests unless the researchers received FDA approval to do so. The FDA says they cannot do so until their lab is approved as a clinical testing facility by the Centers for Medicare and Medicaid Services (CMS), a division of the Department of Health and Human Services (HHS).
Four layers of bureaucracy teamed up to prevent tests that would have improved disease detection and prevention.
Under the national emergency guidelines, the government required all would-be testers to receive an emergency use authorization (EUA) from the FDA. The VITAL Act clarifies that the Public Health Service Act, not the Federal Food, Drug, and Cosmetic Act, governs all aspects of laboratory-developed testing procedures.
When our nation’s healthcare resources are stretched thin, we should make it easier for people to develop tests and treatments, not erect more regulatory barriers.
For these reasons, I urge you to contact your senators and ask them to cosponsor the Verified Innovative Testing in American Laboratories (VITAL) Act, S. 1666.