Watchdog Wednesday: The FDA's New Front Door Is Not Where You Think

Meetings often get a bad rap around the office water cooler or in popular media, be it through Jack Donaghy’s “Four Chairs. Four!” line in 30 Rock or the anti-committee sentiments expressed by heroines in the Star Wars franchise. But meetings are also often the best way for organizations to make decisions, and how leaders conduct them can determine how successful they will be.

In today's Watchdog Wednesday, over the next five minutes, we dig into 18 weeks of public calendars from the people who have been, and now are, running the US FDA.

There is a feedback link at the end. We read every response.

The FDA publishes a weekly "public calendar" listing significant meetings between designated policy makers and people outside the executive branch. The big caveat first: this lists what the agency chose to disclose. It excludes internal meetings, may undercount phone calls, and the variance among directors can reflect either real differences in stakeholder engagement or differences in how diligently each office files paperwork.

With that asterisk, the data we have is the data we have.

We pulled every week from January 4 through May 9, covering Marty Makary's last full quarter as commissioner. Makary logged 91 outside meetings across the period, averaging more than five a week. Acting Commissioner Kyle Diamantas, then serving as Deputy Commissioner for Foods, logged 63 in the same period, 3.5 a week.

Together, those two officials accounted for nearly two-thirds of every public meeting FDA's senior leadership reported.

Now look at the Centers. CDRH Director Michelle Tarver, by far the most outward-facing center director, logged 38. CVM Director Timothy Schell, 10. Acting CTP Director Bret Koplow, 5. Acting CDER Director Tracy Beth Høeg, 2. And CBER Director Vinay Prasad? One. A single appearance at the JPM Healthcare Conference in mid-January, then gone from the calendar and then from the agency.

Given Prasad and Høeg's prickly relationships with industry, the numbers are stark but not surprising, and go a long way toward explaining why they are not at the agency anymore.

What this means for you: The public calendar is an imperfect instrument, but it is the only one we have, and the pattern it reveals is consistent enough to be useful. Who your center director is now matters more than it did a year ago. Tarver at CDRH has been logging the kind of external engagement that suggests an open door. Høeg at CDER was not, and she is gone. The incoming CDER leadership will set a new baseline fast. Watch it from day one.

**A note on the Prasad numbers: he departed FDA before the end of this window, so their counts reflect only the portion of the period they were in post. Even accounting for that, the gap with Tarver is not close.

The contrast between Makary's calendar and Diamantas's is sharp, and everyone in the industry should pay attention because it suggests very different points of access going forward.

Makary led from the podium. Of his 91 meetings, roughly a quarter were with Members of Congress, overwhelmingly Republican. The week of February 22 to 28 alone he held eight separate sit-downs with senators and representatives. Another 15-plus meetings this year were fireside chats at conferences from CES Las Vegas to JPM Healthcare in San Francisco to Leerink in Miami Beach to Milken Beverly Hills to Harvard Medical School. He met with the CEOs of Eli Lilly, Merck, AstraZeneca, Teva, and Novo Nordisk. The pattern was political and performative in the best sense: visible, vocal, on stages.

Diamantas led from the conference table. His 63 meetings broke down differently: roughly 15 with individual food companies (Mondelez three separate times, Mars, Coca-Cola, Chobani, Danone, Sargento, Perrigo, infant-formula makers); 13 with food trade associations; 9 with state or foreign regulators (Brussels, Berlin, Parma, Mexico City, plus North Carolina and Arizona ag departments); 9 with consumer or public-health organizations; and several issue-specific listening sessions on ultra-processed foods, kratom, hemp, leafy greens, and food waste. His Congressional contacts went to committee staff, not Members. His fireside chats were few, mostly the Politico Health Summit and an NPA webinar, tied to substantive program updates.

What does that imply about how he might run the agency? He will have a new job and will have to change accordingly. But if the pattern holds, expect a commissioner who is less likely to be a familiar voice at industry conferences and more likely to convene working groups. Less rope-line; more chairs at a table.

What this means for you: If your FDA engagement strategy has been built around conference visibility and CEO-level relationships, it needs a rethink. Diamantas does not appear to reward presence. He rewards a specific ask, put to the right person, through the right channel. The commissioner's calendar is no longer the front door.

Federal regulators have their own constraints, but the management literature on meetings is worth a look.

A recent Harvard Business Review piece argues that C-suite meetings too often become performative report-outs or firefighting sessions rather than catalysts for forward-looking strategy. The prescription, echoed by Bain partner Michael Mankins in HBR back in 2004: keep strategy meetings separate from operations. For an FDA juggling multiple Centers and competing pressures, that is the whole game.

A 2025 HBR roundup makes a complementary case: shift decision-making to standing capability meetings, five to seven cross-functional groups built around core organizational capabilities, and use one-on-ones for development rather than status updates. Translated to FDA: a standing cross-Center group on drug review timelines, another on AI policy, another on food chemistry reform, another on combination products.

That would push decisions to the right altitude and quiet the bubble-up to the commissioner's desk that produced 91 meetings in 18 weeks.

David Lancefield, also in HBR, noted that meetings are an opportunity to highlight leadership skills, interests, and managerial styles, but only if leaders pay attention to their own contributions. For an acting commissioner with a short runway and a watchful industry, that is not a footnote. It is the whole job.

What this means for you: A more structured FDA, if that is where Diamantas takes it, is a more legible one. Companies that have struggled to get consistent signals across Centers would benefit from that. But it also means the informal channel, the conference hallway, the CEO dinner, the keynote introduction, carries less weight than it did. The work of building regulatory relationships gets more operational and less social. That is an adjustment worth making now, before the new patterns are set.

We’ll be reading the public calendars closely, so stay tuned for updates.

In the meantime, as promised, enjoy the bingo card:

We'll be back tomorrow with Therapeutic Thursday.

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