At this difficult moment of the pandemic, a great deal of distress is the result of a basic disconnect. Even as Americans hear frightening news about record numbers of infections and hospitalizations, there is growing confusion about testing, booster doses and medications — the very tools we use to protect ourselves from Covid-19.
Closing this gap isn’t the job of one federal agency, it’s the job of two. The pandemic has pushed the Centers for Disease Control and Prevention and the Food and Drug Administration to the front lines of the nation’s response. Scientists at the C.D.C. are tracking every twist and turn in the pandemic, while their counterparts at F.D.A. oversee the technologies that keep us safe. Among the agencies’ major challenges, however, has been working together.
Absent a national crisis, both the C.D.C. and the F.D.A. generally stay in their own corners when it comes to medical interventions. The C.D.C. is most known for leading outbreak investigations, publishing public health recommendations and supporting the work of state and local health departments. The F.D.A. sets regulatory policy, reviews confidential drug and device applications from companies and decides whether to permit products to be marketed.
There are good reasons for why the agencies largely do their work apart. Under Title 21 of the U.S. Code on food and drugs, the F.D.A. has the special authority to make regulatory decisions, and the responsibility to do so with integrity. Under Title 42, which governs public health and welfare, the C.D.C. analyzes data from around the world about emerging threats.
Day to day, the F.D.A. interacts with companies, patient groups and consumer advocates, while the C.D.C. engages with states and localities. In Congress, the two agencies report to different subcommittees. At times, White Oak, Md., and Atlanta can feel like worlds apart. When I worked at the F.D.A., it was not uncommon for agency officials to consider correspondence from C.D.C. experts on regulatory questions equivalent to a letter sent in from the public.
The usual division of labor, however, has not worked well during the pandemic. The public has been confused by the lack of clarity around how recommendations are made for vaccines and by the finger-pointing when problems arise. At one low point in February 2020, C.D.C. leaders blocked the access of F.D.A. inspectors to its Covid-19 laboratory — an immediate problem for the review of C.D.C. tests, and perhaps also a reflection of the agencies’ arm’s-length relationship.
It does not have to be this way. Both the C.D.C. and the F.D.A. share the mission of protecting and advancing public health. Greater cooperation would improve the nation’s response to Covid.
A first step is to clarify testing. There are hundreds of tests authorized for sale, including at-home rapid tests and P.C.R. (polymerase chain reaction) tests, with little clarity in how well which tests perform for specific tasks. A major source of the recent confusion over testing recommendations for people after infection was a lack of clear evidence for the accuracy of rapid tests in this situation. C.D.C. experts understand where testing is most needed, and F.D.A. officials can compel companies to collect data to see if their tests work as intended. To date, these key perspectives have not merged into a coherent plan.
Cooperation would start with the C.D.C. outlining the recommended scenarios for testing, such as for diagnosis, for test-to-stay policies that allow students to remain in school if they are negative, for use before a social gathering and for determining whether people are no longer infectious. Then, the F.D.A. could set standards for the data required to be confident that a test works well for each specific use. Eventually, the public should be able to go to either one of the agencies’ websites, choose their situation and see which specific tests they need.
Another step is to work jointly on booster shots. The F.D.A. has largely focused its reviews of booster safety and efficacy on small studies demonstrating increases in people’s antibody levels, while the C.D.C. has reviewed data from around the world on whether immunity is waning in different groups. At times, the back and forth between agency advisory committees and leadership can seem like a game of regulatory Ping-Pong.
A better approach would be for the F.D.A. and C.D.C. to jointly host a regular, open meeting to review emerging data on immunity and booster shots. Scientists at both agencies could then work out a common set of options for review, as needed, by their respective advisory committees. Agency leaders could together announce and explain their respective decisions on market authorization (by the F.D.A.) and clinical recommendations (by the C.D.C.).
An additional step is to answer the urgent questions of parents of young children. Nearly two years into the pandemic, it’s astonishing that vaccine manufacturers have become the leading source for updates about when their vaccines may or may not be available. Parents deserve to hear directly from the public health experts who are guiding the clinical trials and making critical determinations about vaccine authorization and use.
At regular briefings, C.D.C. officials could tell parents about the nature of the risk their young children face and how to reduce it, and the F.D.A. staff could explain the progress of key studies on vaccines for children under 5 and the latest expectations for the timing of regulatory review. Given the intense and understandable public interest, there is no justification for keeping such information confidential.
There are other important areas for collaboration. For example, recently authorized antiviral treatments offer enormous potential, but only if they actually reach the people who need them the most. In 2020, poor coordination over monoclonal antibodies led to delays in developing the clinical capacity to provide these treatments to patients. The agencies should be sharing information about emerging therapies early so that when products are authorized, the infrastructure to link testing with treatment is already in place.
Of course, disagreements between experts at the C.D.C. and F.D.A. may occur. In such circumstances, rather than leave the public perplexed, agency leaders could work with the Department of Health and Human Services and the White House to coordinate carefully on messaging and explain what their different perspectives mean for the pandemic response.
In addition to the immediate benefits of better collaboration between the C.D.C. and F.D.A., there is an indirect value: trust. The agencies are full of experts working incredible hours during the pandemic to save lives. The public will be reassured to see them together, connecting the latest information about the pandemic to the most effective use of tests, medications and vaccines.
Joshua M. Sharfstein (@drJoshS), is a professor of the practice at the Bloomberg School of Public Health at Johns Hopkins. He was principal deputy commissioner of Food and Drug Administration from 2009 to 2011. He also served as the secretary of the Maryland Department of Health and Mental Hygiene from 2011 to 2014.
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