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# FDA Contributed to Covid Test Shortage: Lawyers
- URL: https://www.fdaweb.com/fda-contributed-to-covid-test-shortage-lawyers/
- Published: 2022-01-04T12:00:00.000Z
- Updated: 2026-09-14T17:27:19.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5150859

Attorneys **Jeffrey Gibbs** and **Gail Javitt** say FDA policies and decisions have contributed to the current shortage of Covid diagnostic tests and the agency needs to look at its policies and actions and make changes before the next pandemic comes. Writing in their firm’s *FDA Law Blog*, Gibbs and Javitt [say](https://www.thefdalawblog.com/2022/01/all-too-few-two-year-version-or-where-have-all-the-covid-tests-gone-a-review-of-fdas-policies/?ref=fdaweb.com) that in the two years of the Covid-19 pandemic, FDA has played a critical role as gatekeeper for Covid tests.

They write that the agency’s role has sporadically received attention but has not had a detailed analysis. They addressed that void in a lengthy *FDLI Journal* [article](http://www.fdli.org/wp-content/uploads/2021/12/5-Gibbs-Javitt-Final.pdf?ref=fdaweb.com).

While acknowledging the “herculean efforts and resources” FDA has devoted to reviewing and authorizing Covid assays, Gibbs and Javitt say the agency “has taken steps that have unnecessarily impeded the introduction of assays.” They say it has abruptly changed policies, leaving numerous tests in regulatory limbo and unavailable for use. Its prioritization scheme has been opaque and confusing, the attorneys write, and its implementation has kept Covid tests off the market and hampered decision-making by in-vitro diagnostic companies.

“As we learned first-hand through our counseling scores of companies, and has been reported in the media, the unpredictability of FDA policies had a chilling effect on product development and submissions,” the two say.

In their *FDLI Journal* article, the authors say there is “an urgent need for prompt FDA examination of its role in overseeing Covid-19 tests so the agency can evaluate what has gone well — and much has — and what can be improved. FDA should learn from Covid-19 how to regulate the new diagnostic tests needed for the next pandemic.” The authors say areas for self-examination include: 

- a lack of clear guidance and transparency about policy modifications;
- mechanisms through which applicants can obtain review of agency decisions;
- issues involving laboratory-developed tests; and
- issues with policy changes that are applied retroactively.

“At the height of the pandemic, FDA could not have been expected to conduct a thorough internal evaluation of the agency’s response to this unprecedented challenge,” the authors conclude, “but it is critical that a timely examination take place, while institutional memory is still fresh. This examination should do more than simply point to third-party shortcomings, such as the inadequacies of laboratories and manufacturers, poor promotional practices, the ignorance and misuse of tests by healthcare providers, and insufficient legislative authority from Congress…. At some point — and, we hope, soon — Covid 19 will be brought under control. It will then be critical that a thorough, nonpartisan, scientifically based, and objective review of FDA’s handling of Covid-19 testing be conducted to evaluate what went right and what needs to be improved. FDA and all stakeholders need to learn from these experiences so that we are all more prepared for the next pandemic.”