The Food and Drug Administration's investigational new drug pilot program was discussed at the BIO 2026 convention, where panelists described it as a step toward normalizing agency operations after a period of significant personnel and policy changes. The discussion took place on June 25, with regulatory experts and former FDA officials addressing an audience concerned about recent instability within the agency.
Rasika Kalamegham, head of U.S. regulatory policy at Genentech, asked attendees if they thought the FDA was in crisis a year ago. Most raised their hands, with one audience member saying, “It’s still in crisis.” Kalamegham encouraged panelists to speak candidly about FDA policy. Eva Temkin, formerly of the FDA’s Chief Counsel’s office and Office of New Drugs and now a partner at Arnold & Porter, criticized the agency for its approach to transparency. “We’re going to force transparency but we’re going to do it without transparent process,” Temkin said.
Panelists pointed to the newly announced investigational new drug pilot program as evidence that established protocols are returning. Tala Fakhouri of Parexel said, “If you go to the page with the new announcements, it’s normal process guidance, RFIs, responding to guidance... I am hopeful that things will be trending and changing right now.” At an FDA town hall during BIO 2026, acting Center for Biologics Evaluation and Research Director Karim Mikhail explained that staff rather than leadership developed details for this initiative: “This was not us; this was really the teams.”
Acting Center for Drug Evaluation and Research Director Michael Davis invited public feedback on improving the program so that clinical trials remain in the United States instead of moving abroad. “We really want to hear ideas that people have,” Davis said.
Former FDA official Ritu Nalubola noted during another panel that recent policy announcements from official channels are reassuring after previous releases through journal articles or social media posts under former Commissioner Marty Makary. Nalubola 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?” She concluded by expressing optimism about current developments: “It was heartwarming to see that FDA is coming back, maybe turning around, to establishing policy in a way that it’s supposed to.”
