Pink Sheet Executive Editor Derrick Gingery, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs consider the implications of potential regulations that would cement the FDA’s presumption that it can release complete response letters (:49) and effectively ban direct-to-consumer advertising (18:45), as well as a potential reorganization to create a senior FDA position in charge of all medical products (29:23). More On These Topics From The Pink Sheet US FDA To Clarify, Expand ‘Significant Discretion’ To Publish CRLs: https://insights.citeline.com/pink-sheet/product-reviews/complete-response-letters/us-fda-to-clarify-expand-significant-discretion-to-publish-crls-NYZ2YV2DCFD6HDJ3XTLRZPXSRY/ US FDA Moves To Eliminate ‘Adequate Provision’ For DTC Broadcast Ads: https://insights.citeline.com/pink-sheet/compliance/marketing-and-advertising/us-fda-moves-to-eliminate-adequate-provision-for-dtc-broadcast-ads-5Y32BOH25JEXVLE4ES2JMFHYLQ/ HHS Considering US FDA Reorganization With Medical Products Chief Overseeing Centers: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/hhs-considering-us-fda-reorganization-with-medical-products-chief-overseeing-centers-7DSI2OHYUBHXTO73OBBDJW2QQA/

Drug Fix: New Complete Response Letter, DTC Ad Regulations And A Potential US FDA Reorg

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 and Editor-in-Chief Nielsen Hobbs. Today is July 10th, 2026. It may have seemed like a slow week for the FDA, but there were some under-the-radar regulatory issues that we found and that you should know more about.

Today we'll talk potential changes to the FDA's policy to release Complete Response Letters, updates to DTC advertising regulations, and a potential FDA reorganization. And just a reminder to hit the like and subscribe buttons on Apple Podcasts and Spotify to make sure you're getting every episode. And if you like what you heard, give us a five-star review. First up is Complete Response Letters.

Sue, the FDA's Unified Agenda, which is its annual outline of planned regulations, included an item attempting to clarify its policy to release them, although that's apparently been paused. So what did you find out? Sue, the FDA's Unified Agenda, which is a proposed rule, tentatively set for October, for proactive disclosure of Complete Response Letters.

Now, FDA has been posting most Complete Response Letters for unapproved products since September. Not all. And in this proposed rule, it says it believes it has significant discretion to disclose Complete Response Letters. But it is developing a proposed rule to clarify and expand that discretion.

Now, when you really take a close look at this rule, you know, much of the text of the notice, the proposed rule is not out yet, but much of the text of the notice is targeted at the issue of drug applications that have not been previously disclosed. And how much information FDA can make available for those.

Drug Fix: New Complete Response Letter, DTC Ad Regulations And A Potential US FDA Reorg

Read the full transcript

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

Drug Fix: New Complete Response Letter, DTC Ad Regulations And A Potential US FDA Reorg

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.