AFP Praises HHS Removal of FDA From Premarket Laboratory Testing

Aug 20, 2020 by AFP

Arlington, Va. – The Department of Health and Human Services (HHS) yesterday announced that it is permanently removing a key bureaucratic hurdle to the rapid deployment of laboratory-developed diagnostic tests. HHS clarified that the Food and Drug Administration (FDA) was never required to have review-and-approval authority over that category of tests and, as the department implies, such a bottleneck is not needed. The decision was met with praise from Americans for Prosperity’s (AFP) Health Care Reimagined campaign, which seeks to remove barriers standing between medical professionals and their patients.

AFP Senior Health Policy Fellow Dean Clancy issued the following statement:

“HHS removed a major roadblock in our health care system with this move and the agency deserves credit for its leadership. This will streamline a process that is plagued by administrative red tape, and empower medical professionals to safely develop tests without needless hurdles. Congress should cement the FDA’s current, temporary relaxation of its Emergency Use Authorization rules for infectious disease tests, not only with respect to COVID-19 but infectious diseases generally.”

In early April, as the pandemic spread, AFP released a set of policy recommendations for removing regulatory barriers to help doctors and nurses save lives. Among other recommendations, the group called on Congress and the Administration to codify the wise policy adopted by the FDA a few days before, whereby the agency removed itself as a barrier to testing deployment and decentralized oversight of diagnostic tests. That policy is now enabling states and the private sector to move ahead with broad-based testing.

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