Pharmalittle: We're reading about faster FDA approvals, access to experimental drugs in Montana, and more

ByEd Silverman

Sept. 16, 2026

Pharmalot Columnist, Senior Writer

Ed Silverman

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 morningPharmalittle newsletterand the afternoonPharmalot newsletter.

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,STATnotes. 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.

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Investors on the libertarian fringe of the biotech industry are making their dream of widespread access to experimental drugs a reality in Montana,Politicoexplains. 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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1. Ed Silverman

   Pharmalot Columnist, Senior Writer

   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 morningPharmalittle newsletterand the afternoonPharmalot newsletter.

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