Yesterday, the Trump administration eliminated bureaucratic obstacles set by the FDA and CDC in March that severely restricted the ability of university and other large laboratories that are regulated by the Centers for Medicare and Medicaid from developing screening tests for COVID-19. In guidance issued in early March, and in contradiction of earlier policy, FDA restricted COVID-19 to testing authorized by FDA or the CDC. Prior policy had permitted large laboratories, state public health agencies, and universities to develop tests without FDA authorization. Commercial tests, such as test kits, sold to laboratories have always required FDA approval.
The new restriction came as a surprise to university laboratories that had been developing testing, including in Washington were the outbreak started. As shown by the calls made by FDA, the restrictions were imposed by lower level employees of the agency without public comment and notwithstanding long established policy that such laboratories could develop such tests if developed and run entirely within that laboratory. Adding to the confusion, the CDC’s authorized probes were soon found to be inaccurate resulting in the well-appreciated testing shortage and bottlenecks in approvals. Under pressure from the White House, FDA then removed the restriction for antibody testing but not molecular or COVID-19 testing. The House Congressional Oversight Committee reacted vigorously to this asserted “political” pressure and FDA re-instituted requirements for FDA approval of antibody tests. Simultaneously, the FDA also announced a planned vigorous enforcement strategy against any testing done without prior approval – in contradistinction to prior policy. While the enforcement actions were taken against commercial suppliers, many from China, the effect extended to stopping public health agencies and universities from developing internal tests.
Yesterday, however, the Trump Administration announced that all prior FDA guidance or other announcement or communications restricting public health laboratories, universities and large laboratories regulated by the Center for Medicare and Medicaid were withdrawn and no longer effective returning to pre-March agency policy. And that any further change in FDA’s longstanding authorization for such laboratories to develop important new public health tests would not be changed again unless FDA engaged in formal rulemaking. What this means is that, like the prior policy, any university laboratory, large clinical laboratory, or public health agency may develop COVID-19 diagnostic testing and use that COVID-19 testing, if developed within that laboratory, so long as that specific laboratory development and testing procedures are certified by the Center for Medicare and Medicaid as having adequate procedures to assure the quality of test performance and development. The longstanding policy that commercial tests sold to laboratories, physicians’ offices or in other locations must have prior approval from FDA is unchanged.
To learn more about the issues raised by this client bulletin, please contact Jur Strobos at jstrobos@potomaclaw.com.
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