Tell FDA: Stop Blocking Access to COVID-19 Serological Tests

The FDA is blocking COVID-19 testing at point-of-care facilities such as doctors’ offices and clinics, and instead insisting that, in many cases, they be performed at “high complexity labs,” of which there are only a very few nationwide. This is yet another unfortunate example of the FDA’s complete lack of flexibility during the COVID-19 pandemic. This agency needs to stop getting in the way of widespread testing with excessive red tape.

Write to the FDA, with a copy to Congress, telling them to expand access to serological testing.

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Please stop blocking access to serological tests for COVID-19

Dear [Decision Maker],

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The FDA is blocking COVID-19 testing at point-of-care facilities such as doctors' offices and clinics, and instead insisting that, in many cases, they be performed at "high complexity labs," of which there are only a very few nationwide. This is yet another unfortunate example of the FDA's complete lack of flexibility during the COVID-19 pandemic. This agency needs to stop getting in the way of widespread testing with excessive red tape.

Labs need to receive an Emergency Use Authorization (EUA)--in essence, pre-approval--from the FDA to deploy COVID-19 tests. It was only later that the agency released a policy that allowed companies to develop and offer these tests while they awaited approval of the EUA so as not to waste any more valuable time.

The FDA's policy allowed companies to begin offering serological tests, both in labs and at point of care, while waiting for the FDA's approval of the EUA as long as certain conditions were met.

In subsequent statements, however, the FDA hit serological tests with more red tape. The agency stated that their policy was silent about the status of these tests under the Clinical Laboratory Improvements Act (CLIA). CLIA requires that "high complexity" tests be performed in high complexity labs unless the test is waived. The FDA further states that all tests offered under the new policies are high complexity by default until or unless they are deemed otherwise through an EUA or general FDA review process.

The point is this: serological tests developed to be used by healthcare workers at point of care can only be performed in high complexity labs. Only after an EUA for a point of care serological test is approved by the FDA can the test be conducted outside of a high complexity lab.

The FDA and other government health agencies are making it harder to get COVID-19 testing at locations where it would be most beneficial and convenient. Please remove these barriers so Americans can have greater access to these tests.

Sincerely,
[Your Name]
[Your Address]
[City, State ZIP]
[Your Email]