Efforts by the Centers for Disease Control and Prevention (CDC) to control the COVID-19 pandemic have been widely criticized, with veteran public health experts describing its “failings” as “notable.” Unfortunately, the Biden administration has prevented some meaningful reform of the CDC’s guidance practices, overturning a Trump administration regulation that would have required the CDC to comply with certain good guidance practices. Real progress, then, will require congressional action.
Throughout the pandemic, the CDC knowingly released flawed diagnostic tests, neglected its own best practices in risk communications, and issued recommendations for temperature screening methods that “do not work.” It provided guidance for schools so flawed it drew a public rebuke from the very scientists it cited. The CDC’s recommendations for preemptive coordinated school closures likely contributed to the large and discouraging decline in students’ academic performance since 2020, including a growing gap in test scores between low and high poverty elementary schools, as well as adverse effects on kids’ mental health and parents’ jobs and wages.
The CDC’s failings stem in large part from the autocratic ways it issues recommendations or guidance. It does not solicit or systematically allow public comment on its guidance, either before or after they are issued. It does not provide a comprehensive searchable database of all current guidance, complicating efforts to keep track of closely related ones. And it often issues guidance without a scientific or technical rationale explaining the agency’s thinking.
Fortunately, Congress can find the blueprint for reform by looking at the experience of another Health and Human Services (HHS) agency: the Food and Drug Administration (FDA). For two decades the FDA has issued wide-ranging guidance following its own good guidance practice regulation. The FDA issued 163 guidance documents under this regulation in 2020 alone — including during the stressful and confusing start of the pandemic.
The FDA’s practices keep the agency from issuing willy-nilly recommendations about what regulated entities “should” or “ought to” do. The FDA’s good guidance practices explicitly allow regulated entities to not follow FDA recommendations, provided that they comply with existing statutory and regulatory requirements as stated in relevant statutes and regulations. Importantly, the FDA practices require it to solicit public comment, but allow it to do so after, rather than prior to, issuing guidance, if it determines that getting public comments first is not necessary or appropriate.
Congress should require the CDC to change its process for issuing public health guidance to make it less autocratic; more responsive to public concerns; more transparent; and more explicitly science-based. In particular, the CDC needs to adopt good guidance practices, similar to the ones that the FDA follows. Additionally, it must provide a reasoned scientific basis for its policy recommendations, including a systematic review of relevant studies, an effort to distinguish between associations and causal relationships, and an assessment of how specific recommendations would lead to greater public health benefits and the associated risks.
The FDA’s experience demonstrates that it is feasible and worthwhile for the CDC to adopt a similar regulation. Given recent threats of new communicable diseases, including monkeypox and poliovirus, such reform is increasingly important. It is up to Congress to act.
Randall Lutter, Ph.D., is a senior fellow at the Manhattan Institute, where his research focuses on pharmaceutical markets and policy, medical innovation and regulation. He was a senior science and regulatory adviser in the Office of the Commissioner at the U.S. Food and Drug Administration from 2017 to 2020.
https://thehill.com/opinion/healthcare/3680265-why-congress-should-step-in-and-regulate-the-cdc/
