Policymaking at FDA has been anything but business as usual under the Trump administration, but former regulators cite the agency’s new investigational new drug pilot program as a sign of normalcy.
After summarizing a long list of personnel and policy changes that have taken place at the FDA over the past year and a half, Rasika Kalamegham turned to the audience at BIO 2026 with a question: “Did you think the FDA was in crisis a year ago?”
Just about everyone raised their hands, and a voice from the crowd rose above the murmurs, “It’s still in crisis.”
Kalamegham, head of U.S. regulatory policy at Genentech, then invited her panelists to imagine they were not on stage at the biggest biotech convention of the year but in her home, having wine and cheese and a candid conversation about FDA policy.
They took her cue and did not mince words. Eva Temkin, formerly in the FDA’s Chief Counsel’s office and Office of New Drugs, lambasted the agency’s hypocrisy around the concept of transparency, describing a “callous disregard for policymaking in an open and transparent way.” Now a partner at Arnold & Porter, Temkin cited the FDA’s initiative to publicly release complete reponse letters (CRLs) as a prime example of a change that was dropped under the guise of transparency without engaging relevant stakeholders or fully explaining the rationale behind the decision.
“We’re going to force transparency but we’re going to do it without transparent process,” Temkin said.
But the speakers pointed to the FDA’s investigational new drug pilot program, announced on Monday, as a sign that proper protocols are returing to the agency.
“If you go to the page with the new announcements, it’s normal process guidance, RFIs, responding to guidance,” said Parexel’s Tala Fakhouri, formerly at the Center for Drug Evaluation and Research (CDER’s) Office of Medical Policy. “So, I am hopeful that things will be trending and changing right now.”
At an FDA town hall at BIO on Tuesday, agency leadership pulled back the curtain on the new initiative’s formation, which is aimed at encouraging early clinical research in the U.S. as data show that more and more trials are launching in China.
Emphasizing that it was a collaboration between Center for Biologics Evaluation and Research (CBER) and CDER, acting CBER Director Karim Mikhail emphasized another bit of normalcy, noting that this was not something issued from leadership without staff input. Rather, he said, the details of the policy proposal were worked out by the boots-on-the-ground FDA employees. “This was not us; this was really the teams.”
The proposal is now available for public comments—yet another sign that business is returning to usual. Acting CDER Director Michael Davis encouraged attendees of the town hall to take advantage of that opportunity to provide feedback on how the program can be further improved to ensure the U.S. doesn’t continue to cede clinical trials to China or elsewhere.
“We really want to hear ideas that people have,” Davis said, “because this is a challenge that we’re all really taking seriously and doing everything that we can.”
Finally, after a year that saw several policies released via unconventional means, just the fact that the announcements are coming from the agency itself is reassuring, former FDAer Ritu Nalubola, now director of Life Sciences and Healthtech at the Marwood Group, said during another BIO 2026 panel.
“Seeing some of these announcements come through journal articles or social media posts was really shocking,” Nalubola said of the approach under former FDA Commissioner Marty Makary. The waters became even more muddied when Makary and CBER Director Vinay Prasad left the agency, she added. “If the policy that was announced in a journal article by two individuals who are no longer at the agency, what does this mean? Is it in fact FDA policy? Are reviewers in fact implementing this policy?”
But now, Nalubola agrees that the agency appears to be getting back on track. In addition to the IND program, she pointed to new draft guidance explaining the agency’s effectiveness standard released this month.
“It was heartwarming to see that FDA is coming back, maybe turning around, to establishing policy in a way that it’s supposed to.”
