Pink Sheet Executive Editor Derrick Gingery, Senior Reporter Maaisha Osman, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs consider the impact of the US Food and Drug Administration clarifying that journal articles written by former commissioner Martin Makary and others were not official guidance (:58). They also discuss the questions an FDA commissioner nominee could field from Senators based on the recent confirmation hearing for President Trump’s US Centers for Disease Control and Prevention and Health and Human Services Assistant Secretary for Preparedness and Response nominees (15:12). More On These Topics From The Pink Sheet US FDA Says Two Makary, Prasad Journal Articles And NPV FAQ Were Not Policy Or Guidance: https://insights.citeline.com/pink-sheet/legislation/us-fda-says-two-makary-prasad-journal-articles-and-npv-faq-were-not-policy-or-guidance-6MCDQTKVXFG7TJ7IWOT6YMW4CA/ US CDC, ASPR Nominees’ Confirmations In Question After Contentious Senate Hearing: https://insights.citeline.com/pink-sheet/agency-leadership/us-cdc-aspr-nominees-confirmations-in-question-after-contentious-senate-hearing-3TX2W6HSXRACJELUX2CYY6ICVY/

Drug Fix: US FDA Undoes Podium Policy, Lessons From CDC, ASPR Confirmation Hearings

Citeline Podcasts

Hello and welcome to another edition of Drug Fix, the Pink Sheets Pharma Regulatory Podcast. I'm Derek Ingerie, an Executive Editor at the Pink Sheet, and I'm joined by Senior Editor Sue Sutter, Senior Reporter Maisha Osman, and Editor-in-Chief Nielsen Hobbs. Today is July 17th, 2026. Today we're going to discuss the FDA clarifying former Commissioner Martin Makary's podium policy

and the surprising hostility senators directed at the CDC and ASPR nominees and how that could affect the upcoming FDA Commissioner nominee. Just a reminder to hit the like and subscribe buttons on Apple Podcasts and Spotify to make sure that you're getting every episode. And if you like what you heard, give us a five-star review. Also, if you plan to bet on the new Calci Clinical Trial Prediction Market, please let us know your strategy. I'm curious how the biotech world has responded to this.

But first up is FDA podium policy or speeches, journal articles, and other non-traditional methods to notify industry of policy changes. Maisha, you covered a congressional hearing where this came up. So what did you find out? Yeah, so for most of the past decade, FDA policy has been communicated through a formal process, guidance documents, public comment periods. And we spoke about it before in our podcast too.

So during McCary's tenure as FDA commissioner, he started, we started seeing something different like policies, ideas were floated through journal articles. And that's what representative Diana Decet, she's the ranking member on the House Energy and Commerce Health Subcommittee. She sent a letter to FDA in February asking whether good guidance practices were violated when these policies were announced through the journal articles.

Drug Fix: US FDA Undoes Podium Policy, Lessons From CDC, ASPR Confirmation Hearings

Read the full transcript

The candid version is on a podcast,
not the earnings call.

Drug Fix: US FDA Undoes Podium Policy, Lessons From CDC, ASPR Confirmation Hearings

Read the full transcript

The candid version is on a podcast, not the earnings call.

The candid version is on a podcast,
not the earnings call.