BOGOTA, COLOMBIA - AUGUST 14:  View of stored plasma donated by patients who recovered from COVID-19 on August 14, 2020 in Bogota, Colombia. A group of researchers from the Institute of Science, Biotechnology and Innovation in Health (IDCBIS) work on a treatment with convalescent plasma to test its effectiveness, which is now 80%, on COVID-19 active patients. Positive coronavirus cases continue to grow rapidly in Colombia, according to the Ministry of Health there are more than 430,000 cases and registers over 14,100 deaths. (Photo by Guillermo Legaria/Getty Images)
What exactly is convalescent plasma therapy?
01:31 - Source: CNN

Editor’s Note: Dorit Reiss is the James Edgar Hervey Professor of Law at the University of California, Hastings College of the Law. The opinions expressed in this commentary are solely those of the author. View more opinion at CNN.

CNN  — 

We have a problem.

Recent developments have caused concern among scientists and experts over the independence of both the US Centers for Disease Control and Prevention and the US Food and Drug Administration.

There are indications that President Donald Trump’s administration is putting political pressure on these agencies, desperate to show some headway in response to Covid-19, after the pandemic has killed over 185,000 Americans, hospitalized hundreds of thousands, and sickened millions.

Worse, many fear such pressure is effective in turning these agencies away from science and toward apparently political decisions. This is not a slur on the civil servants in these agencies. From the outside, it looks like they are being circumvented.

This week, after long promising to stand on the side of science in overseeing the vaccine development process, FDA Commissioner Stephen Hahn said he would consider an Emergency Use Authorization (EUA) for a Covid-19 vaccine before Phase 3 trials are complete.

In some circumstances, ​an EUA can be justified. For example, when there are several months of good safety data and strong effectiveness indicators, and it’s for a limited high-risk situation. But other developments – like the FDA’s apparently headlong approval, and then withdrawal, of an EUA for hydroxychloroquine this summer– raise concerns that it will be issued for political reasons, before enough data is available.

​This is also in the wake last week of extremely inaccurate statements made by Commissioner Hahn in relation to an EUA for Covid-19 convalescent plasma.

This all raises real fears about the possibility of an unfounded EUA issuance for vaccines. That would be bad: it could bring to market a vaccine without sufficient testing, which can, potentially, turn out either to have harms that outweigh its benefits, or not work.

This will undermine trust not only in that vaccine, but potentially in other Covid-19 vaccines, and maybe even the vaccine program. Also of concern: the CDC has recently published guidelines that remove its recommendation for testing asymptomatic patients – a move heavily criticized by public health experts.

I have no doubt the career scientists at the CDC and the FDA, people who have devoted decades to working to prevent diseases and saving lives, to science and oversight, are extremely frustrated and distressed. But they cannot fix it. The fix has to come from the outside.

And this is fixable. First, one of the problems for the CDC is that many of its powers are not expressly coded in a statute. They derive from executive action, based on powers granted the Secretary of Health in the Public Health Services Act. This means that if the executive wants to interfere in CDC’s action or remove powers, there is little legal barrier. Congress can and should protect the agency by enacting a statute codifying its roles and authority in preventing diseases.

That will not, however, be enough. At an immediate level, there is a bill before Congress, the SAVE Act, which would, among other things, codify the role of advisory expert committees – not vulnerable to political manipulation – in decisions related to the vaccine, and increase transparency.

On a more long-term basis, lawmakers should consider strengthening the institutional independence of public health agencies to pull them from under the political administration’s sway. There is a limit to what can be done there. First, the appointment clause of the Constitution prevents complete non-political appointment of agencies heads. Second, there is a high cost to complete isolation of expert agencies from politics. Such isolation can lead to decisions that ignore broader social values, and the lack of oversight can even lead to less cautious decision-making or a relationship with industry, for example, that is too cozy.

But it is constitutional to have agencies with multi-member boards appointed for staggered periods, and to give those board members protection from removal before the end of the term, limiting removal to cause. Those boards do provide a stronger layer of independence compared with single-head agencies whose heads are removable at the will of the president.

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The CDC director is currently appointed by the president – no need for Senate approval – and removable at will. The FDA director is appointed by the president with advice and consent of the Senate and removable at will. We can and should change that, by changing the agencies’ leaderships to a multi-member board whose members serve for staggered terms and enjoy removal protections. Multiple agencies have such an arrangement, and the strongest one we have is the Federal Reserve, governed by a board appointed for 14 years and protected from removal.

​Our public health agencies have a long tradition of careful, science-based service. We can support that by giving them more institutional independence.