How the FDA should protect its integrity from politics

Joshua Sharfstein in Nature:

To define integrity at the FDA a decade ago, I turned to the agency’s chief scientist, top lawyer and leading policy official. They set out three criteria (see The first was that decisions should be “based on a rigorous evaluation of the best available science”, drawing on “appropriate expertise, including the use of advisory committees”. Today, the agency has yet to consult such a committee for a major decision on COVID-19. Instead, criticism of FDA actions from non-agency scientists, including the leaders of the US National Institutes of Health, has filtered into news reports, sowing doubts about whether potential risks and unintended consequences have been properly considered.

The second criterion was that decisions should be “reached and documented through a process that promotes open-mindedness”, with the “bases of final decisions and processes for decision-making … adequately documented and explained”. In other words, transparency is crucial to integrity; without seeing the evidence and hearing the reasoning, people often assume the worst.

Globally, the lack of transparency about decision-making is eroding trust in many governments whose response to the pandemic has been poor. The FDA has disclosed little about how it is making decisions, squandering the chance to build up understanding and support. During my time at the FDA, agency leaders met challenges, such as debates about the safety of diabetes medicines, by releasing detailed memos, publishing explanatory articles in medical journals and giving press interviews. The third criterion of integrity was that decisions should be “made without inappropriate or external interference”. It stipulated that “data and opinions are not suppressed, distorted, or manipulated” and that “pressure from external persons does not influence the regulatory decision”.

There can be no doubt that Trump’s attacks aim to influence decision-making at the agency.

More here.