The Washington Post editorial board got FDA’s two top officers—Commissioner Robert Califf and Principal Deputy Commissioner Janet Woodcock—to sit down for a food safety-focused Q&A on Jan. 6. They talked about last year’s baby formula crisis, culture and morale within the agency and the suggested restructuring of the FDA.
We think the biggest bullet point: Califf said they’re “weeks away” from announcing some kind of restructuring of FDA. You might want to read the unabridged version yourself — all 2000 words of it (might require a subscription) — but we’ve reduced it to about 250 here, with just a little interpretation:
WaPo: Should the FDA be broken up so there is a separate human food agency?
(After 400 words) Califf & Woodcock: That’s not our call to make.
WaPo: If we don’t break up the FDA, then how can we ensure there is true reform in the human food division after years of problems?
(After 1000 words) Califf: “We are coalescing on a plan.” “We are a couple of weeks away from announcing [a proposed new] architecture.”
“Almost 100 percent of what’s in the [Reagan-Udall Foundation] report is quite good. Actually operationalizing it is a different kind of work that takes into account a lot of ‘sausage making.’ ”
“… [about] the report’s reference to ‘constant turmoil.’ The FDA as a whole is always in constant turmoil because we’re making thousands of decisions a month that affect a lot of people. A high proportion of those decisions make somebody unhappy, and it’s stressful.”
WaPo: What else needs to be done to modernize food safety? / Most Americans probably think you already have access to all the data you need.
Califf: “When there’s a shortage [of baby formula, for example], we have to go begging for data. Legally, we can’t get the data unless they agree to give it to us. Similarly, with the states [state food safety inspections and programs], if we give them data and they make it publicly available, we’re liable.”
OUR SUMMARY: No great revelations, but they seem to be working on it. And they did promise “We are a couple of weeks away from announcing [a proposed new] architecture.”
