---
title: "FDA pilot to speed human testing and Montana’s private board expands access to experimental drugs"
id: "stat-news-1-stat-pharmalittle-we-re-reading-about-faster-fda-approvals-access-to"
canonical_url: "https://medichelpline.com/clinical-feed/stat-news-1-stat-pharmalittle-we-re-reading-about-faster-fda-approvals-access-to"
content_type: "clinical_feed_article"
specialty: "Pharmacology"
source_name: "STAT News"
source_url: "https://www.statnews.com/pharmalot/2026/09/16/fda-plans-to-speed-approvals-experimental-drugs-in-montana/?utm_campaign=rss"
published_at: "2026-09-16T13:29:12.000Z"
evidence_level: "Verified Feed"
license: "CC-BY-NC-4.0 / Informational Use"
---
# FDA pilot to speed human testing and Montana’s private board expands access to experimental drugs
## Provenance & Clinical Metadata
- **Canonical URL:** https://medichelpline.com/clinical-feed/stat-news-1-stat-pharmalittle-we-re-reading-about-faster-fda-approvals-access-to
- **Specialty:** [Pharmacology](https://medichelpline.com/clinical-feed/pharmacology.md)
- **Primary Source:** STAT News
- **Source URL:** [Original Journal Publication](https://www.statnews.com/pharmalot/2026/09/16/fda-plans-to-speed-approvals-experimental-drugs-in-montana/?utm_campaign=rss)
- **Published At:** 2026-09-16T13:29:12.000Z
- **Evidence Rating:** Verified Feed
## Executive GIST (TL;DR)
- The U.S. **Food and Drug Administration (FDA)** is accepting applications for a pilot program intended to shorten the time it takes for drugmakers to begin testing products in humans. The pilot is tied to the Department of Health and Human Services’ **Operation TrialBlazer** initiative. - Operation TrialBlazer aims to shorten FDA drug approval timelines and help U.S. industry compete with rapidly accelerating biotech sectors in countries such as China and Australia. - The pilot seeks to establish a network of “qualified research institutions” that will partner with companies to develop and review **Investigational New Drug** (IND) application packages, with the goal of speeding entry into human trials. - Investors described as being on the “libertarian fringe” of biotech have helped create state-level pathways to broaden access to **experimental drugs**, with Montana as a focal example. - Montana enacted a law last year to expand access to treatments that have not been deemed safe and effective by regulators; implementation in the state now relies on a privately run board to decide which treatments to offer. - The involvement of a private board raises concerns about potential conflicts of interest and whether patients will receive value, given the industry’s history of unfounded claims. - The private company administering Montana’s program reportedly works with biotech firms in a zone off the coast of Honduras that lacks a drug regulator, and startup firms hope Montana will serve as a shortcut around the FDA’s costly and extensive development process. - The source references a headline about the Novo Nordisk CEO urging employees to be more customer-focused, but the article body did not report further details about that item. - Several referenced items in the original piece are behind a STAT+ paywall; where the source did not provide full information, specific details are noted as not reported in the source.
## Clinical Analysis & Structured Key Points
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Test your knowledge with our new weekday mini crossword [ Start solving ](https://www.statnews.com/stat-mini-crossword/) [STAT Plus](https://www.statnews.com/stat-plus/)Newsletter[Pharmalot](https://www.statnews.com/category/pharma/pharmalot/) # Pharmalittle: We’re reading about faster FDA approvals, access to experimental drugs in Montana, and more ## Novo Nordisk CEO urged employees to be more customer-focused * [Manage alerts for this article](https://www.statnews.com/my-account/edit/#emails) * [Save this story for later](https://www.statnews.com/my-account/saved/) * [Share this article](https://www.statnews.com/pharmalot/2026/09/16/fda-plans-to-speed-approvals-experimental-drugs-in-montana/?utm_campaign=rss) ![an anthropomorphized red and blue pill illustrated in the style of the famous american gothic painting](https://www.statnews.com/wp-content/uploads/2015/11/PHARMALOT_LITTLE-copy-645x645.jpg) Alex Hogan/STAT ![](https://www.statnews.com/wp-content/uploads/2021/02/ed-s-avatar-small4-80x80.png) By [Ed Silverman](https://www.statnews.com/staff/ed-silverman/) Sept. 16, 2026 Pharmalot Columnist, Senior Writer ![](https://www.statnews.com/wp-content/uploads/2021/02/ed-s-avatar-small4-80x80.png) [Ed Silverman](https://www.statnews.com/staff/ed-silverman/) 1. [](https://www.linkedin.com/in/edsilverman/ "Linkedin") 2. [](https://x.com/Pharmalot "X") ed.silverman@statnews.com Ed’s stories explore prescription drug pricing, affordability and access, as well issues surrounding patents, litigation, and legislation. He is also the author of the morning [Pharmalittle newsletter](https://www.statnews.com/signup/pharmalittle/) and the afternoon [Pharmalot newsletter](https://www.statnews.com/signup/pharmalot/). Good morning, everyone, and welcome to the middle of the week. Congratulations on making it this far, and remember there are only a few more days until the weekend arrives. So keep plugging away. After all, what are the alternatives? While you ponder the possibilities, we invite you to join us for a needed cuppa stimulation. Our choice today is pomegranate green tea, which we discovered while digging about our pantry. Meanwhile, here is the latest menu of tidbits to help you on your way. We hope you conquer the world and have a wonderful day. And as always, please do stay in touch. Tips, criticism, and all sorts of feedback is always appreciated. … **The U.S. Food and Drug Administration is opening applications for a pilot program designed to shorten the time it takes for drugmakers to begin testing their products in humans** , [STAT](https://www.statnews.com/2026/09/15/fda-launches-program-to-shorten-drug-approval-times/) notes. The pilot was first announced in June as part of Operation TrialBlazer, a U.S. Department of Health and Human Services initiative that pledged to shorten FDA drug approval timelines and help the U.S. compete with the rapidly accelerating biotechnology industries in countries like China and Australia. The pilot program seeks to create a network of “qualified research institutions” that will partner with companies to develop and review their Investigational New Drug application packages. Advertisement **Investors on the libertarian fringe of the biotech industry are making their dream of widespread access to experimental drugs a reality in Montana** , [Politico](https://www.politico.com/news/2026/09/15/montana-biotech-prospera-fda-right-to-try-drugs-01075911) explains. Last year, they helped draft a state law to expand access to drugs that no regulator has deemed safe and effective. Now, Montana is relying on a privately run board to decide which treatments to offer — raising concerns about conflicts of interest and, in an industry rife with unfounded claims, whether patients will get value for their money. The company in charge works with biotech firms in a zone off the coast of Honduras that has no drug regulator. Startup biotech firms hope Montana will serve as their shortcut around the FDA’s costly and extensive drug development process. 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