Pathways’ Pick of the Week: Playing Politics with FDA

Complaints about FDA bowing to political pressure are not a new phenomenon. But the levels to which the agency’s decision-making has been thrust into the political spotlight over the past week should give anyone who depends on the global reputation of FDA to help validate new medical technologies pause.

President Trump’s August 22 tweet complaining about a “deep state” within FDA delaying development of COVID-19 vaccines and treatments is the most blatant incident yet of direct public pressure on the agency. That was followed the next day by a White House news conference announcing FDA Emergency Use Authorization of convalescent blood plasma as a COVID-19 treatment. The decision came following pushback from scientists, including at the National Institutes of Health, although FDA denied any political motivation.

And several days before that, the administration made a decision in the medtech arena that also triggered some double takes. On August 19, HHS announced that FDA would no longer be able to require premarket review of laboratory-developed tests—whether EUAs for COVID-19 tests or 510(k)s/PMAs for non-emergency diagnostics—absent notice-and-comment rulemaking.

In some other contexts, the decision would not necessarily be surprising. FDA has maintained for years that it has the authority to regulate LDTs—tests that are developed and performed as a service within the same high-complexity lab—but it has largely practiced “enforcement discretion,” allowing such tests to operate without agency scrutiny. The clinical laboratory community, however, has questioned FDA’s legal authority in this area, and insisted, at minimum, that a rulemaking process is needed to lay out a clear regulatory framework, rather than relying on guidance documents, as FDA has in prior (unfulfilled) attempts to bring LDTs into its regulatory fold. It is not shocking that the Trump administration might favor the labs’ position, given White House’s strong stance in favor of “deregulation.”

With regards to the impact of the new policy for COVID-19, there is debate among experts. Some argue that FDA’s policy up until now to require EUAs for high-complexity labs—when the same labs don’t typically need FDA review when there is no ongoing emergency—has unnecessarily delayed the pandemic response. Others contend its especially important to ensure test accuracy during a public health emergency. 

But the administration’s August 19 announcement raises more questions, in part, due to its abruptness. Up until now, FDA, over the past two years, has been some ways more active compared to prior administrations in targeting enforcement at LDTs deemed not to be supported by evidence. It is also noteworthy because it came in the form of a HHS notice, rather than a policy document from FDA, and reports followed the announcement that the decision came as a surprise to FDA officials and was opposed by FDA Commissioner Stephen Hahn. The subsequent statement by the president about a “deep state” within FDA makes it ever more difficult not to consider the potential impact of outside influence.

And that is really the point. Such politicized statements about FDA from the White House can have the effect of tainting the agency’s decision-making in the public eye, even in cases when a decision might have been made in good faith. The first-order concern is that public trust in FDA decisions will be crucial to successfully countering the pandemic with testing, treatments, and vaccines. But, more broadly, all developers of new medical technology depend on a basic, public trust in FDA to gain traction from patients and doctors. That is, of course, true in the US, but it is also the case globally, where many authorities and healthcare providers around the world have viewed FDA as a “gold standard” that can help support adoption of new technology.

Maintaining independence, and the perception of independence, for the FDA is also important for dedicated, career officials within the agency to do their jobs effectively. For instance, reviewers wanting to counter perceptions of political influence could revert to taking a more conservative approach to some applications. Jeff Shuren and his team at CDRH are operating on all cylinders right now to support new innovations, both for COVID-19 and the universe of other healthcare needs, in the face of serious resource challenges. But the more the agency’s decisions are viewed through a political, rather than scientific and legal, lens, the more difficult it may become to implement creative, innovation-friendly regulatory solutions.

[Pictured: FDA Commissioner Stephen Hahn speaks from the White House  press briefing room]