If You Are Not Confused, Then You Are Not Paying Attention: FDA Edition
“Flooding the zone” has worked as a strategy for the Trump Administration, at least so far. We are all so busy reacting to the newest proposals that we don’t have time to address the previous week’s initiatives from the Administration.
While I can’t seem to get ahead, I usually have a good sense of what is coming next or, at least, the range of possibilities. That’s an important aspect of both my FDA Matters writing and my client work.
However, it has been unusually difficult this year because of another strategy being used by this Administration: pervasive norm-breaking. Norms limit the number of plausible scenarios even in complex situations. Without norms, our predictions have to account for a nearly endless stream of improbable possibilities that cannot be eliminated.
In contrast, FDA’s strength should be in its predictability, the opposite of norm-breaking. The agency reliably sets and enforces standards (norms) for $3 trillion worth of goods and services.
Because of norm-breaking scenarios, my FDA crystal ball has never been more opaque. Here are some of the items with the most impact and the least clarity:
Will the Secretary Try to Control FDA? Secretary Kennedy’s predecessors were chosen for a combination of their management experiences, and political and policy chops.[1] Kennedy has none of that, plus he has no known interest in how his predecessors ran the department.
So, it is unclear whether he will adhere to past norms about when--and how much--the Secretary of HHS intervenes in FDA’s decisions and operations. Here is my interpretation of those norms:
Budget: okay for HHS to intervene;
Regulatory policy: okay for HHS to intervene on a case-by-case basis on major items;
Product decisions: not okay for HHS to intervene, but there is some history of HHS involvement in reproductive health products; and
scientific and medical evaluations and information: not okay for HHS to intervene.
Nothing prevents the Secretary from breaking those norms and making himself the final clearance for all FDA actions, including product decisions.[2] How can we predict or create scenarios for future FDA actions if intervention by the Secretary--ad hoc, selective, total, or permanent--is an ever-present variable?
Will the Commissioner Defend FDA’s Independent, Science-Based Evaluations? I feel certain that Commissioner Makary intends to stand up for FDA with regard to scientific and medical evaluations and information. He didn’t take the Commissioner’s job so that others above him--who do not have appropriate education or training--could substitute their medical and scientific judgment for his own and that of FDA staff.
However, with an unpredictable and self-certain HHS Secretary who is interested in public health, food, nutrition, and vaccines, a continuing stream of large and small disagreements seems inevitable. Some may be uncomfortable or worse for Dr. Makary. We could see this as soon as next week when the MAHA report comes out…or it could come at any time down the line.
How these conflicts are resolved is all-important to predicting future FDA actions. Yet, the situation is opaque, at least in part because norm-breaking opens up so many possibilities.
How Much Can FDA Do With Reduced Staff? While far, far from perfect, FDA mostly fulfills its responsibilities and completes its tasks in credible fashion, and in a reasonably timely manner. That is the norm we are all used to.
Because of the 20-25% staff loss, I have urged FDA and the Commissioner to engage in some truth-telling about what the agency can still do and in what timeframe.[3] I am doubtful that things are fine. I assume there will be an increasing number of missed deadlines.
Much of FDA’s future over the next couple of years depends on whether there is a staff shortage and how existing staff are deployed. What is the new norm for FDA in this regard? We do not know and may not know for months. The situation is opaque and makes scenario-building and prediction nearly impossible.
FDA will survive whatever comes next…and the next thing after that. However, our ability to see the agency’s direction and predict its future depends on the resolution of several unknowns. The potential for norm-breaking by the Administration multiplies the scenarios and makes each situation opaque.
https://www.fdamatters.com/fdamatters/is-rfk-jr-better-suited-to-be-an-advisor-than-an-executive
From an earlier FDA Matters column: FDA statutory authority is assigned to the Secretary, who has delegated it to the Commissioner, who I believe has delegated certain decisions to the center directors. All of these delegations can be withdrawn, in whole or part, at any time. https://www.fdamatters.com/fdamatters/fda-and-politics-an-unhealthy-combination.
https://www.fdamatters.com/fdamatters/truth-telling-fda-user-fee-edition