---
title: "Law Must Address 340B Treatment of Orphan-Designated Drugs Used for Multiple Conditions"
id: "stat-news-1-opinion-the-law-has-to-catch-up-on-orphan-designated-drugs-with-multiple-uses"
canonical_url: "https://medichelpline.com/clinical-feed/stat-news-1-opinion-the-law-has-to-catch-up-on-orphan-designated-drugs-with-multiple-uses"
content_type: "clinical_feed_article"
specialty: "Pharmacology"
source_name: "STAT News"
source_url: "https://www.statnews.com/2026/10/02/340b-policy-orphan-designated-drugs-pharmacy-losses-hrsa-congress/?utm_campaign=rss"
published_at: "2026-10-02T08:30:00.000Z"
evidence_level: "Verified Feed"
license: "CC-BY-NC-4.0 / Informational Use"
---
# Law Must Address 340B Treatment of Orphan-Designated Drugs Used for Multiple Conditions
## Provenance & Clinical Metadata
- **Canonical URL:** https://medichelpline.com/clinical-feed/stat-news-1-opinion-the-law-has-to-catch-up-on-orphan-designated-drugs-with-multiple-uses
- **Specialty:** [Pharmacology](https://medichelpline.com/clinical-feed/pharmacology.md)
- **Primary Source:** STAT News
- **Source URL:** [Original Journal Publication](https://www.statnews.com/2026/10/02/340b-policy-orphan-designated-drugs-pharmacy-losses-hrsa-congress/?utm_campaign=rss)
- **Published At:** 2026-10-02T08:30:00.000Z
- **Evidence Rating:** Verified Feed
## Executive GIST (TL;DR)
- The author, John Mildenberger, is a specialty pharmacy manager and senior clinical lead pharmacist at Sidney Regional Medical Center in Sidney, Nebraska. - He founded a specialty pharmacy in a rural community where patients travel long distances to pick up specialty medicines in person. - Local patients value in-person access and counseling at the pharmacy for conditions such as **Crohn’s disease** and for obtaining drugs like **Rinvoq**. - The author reports that dispensing some specialty medicines can produce a **staggering loss to the pharmacy**, meaning the pharmacy sometimes pays more to acquire the drug than it receives in reimbursement. - The piece argues that federal policy does not adequately distinguish between different clinical uses of drugs that carry an **orphan designation**, exemplified by Crohn’s disease versus juvenile idiopathic arthritis. - The title and framing call out the **340B** program and the law’s need to catch up when orphan-designated drugs have multiple approved indications, but the article text presented does not provide specific policy proposals, data, or regulatory actions. - Details such as specific 340B policy changes, financial figures quantifying pharmacy losses, HRSA guidance, congressional actions, or case examples beyond the author’s practice are not reported in the provided source text.
## 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/) Opinion[First Opinion](https://www.statnews.com/category/first-opinion/) # The law has to catch up on orphan-designated drugs with multiple uses ## Crohn’s disease is not juvenile idiopathic arthritis. Why does 340B treat them like they’re the same? * [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/2026/10/02/340b-policy-orphan-designated-drugs-pharmacy-losses-hrsa-congress/?utm_campaign=rss) ![](https://www.statnews.com/wp-content/uploads/2026/06/AdobeStock_368502455-645x645.jpeg) Adobe By John Mildenberger Oct. 2, 2026 Mildenberge is the specialty pharmacy manager, senior clinical lead pharmacist, and community pharmacy compliance officer at Sidney Regional Medical Center in Sidney, Neb. As sure as the sun rises, Crohn’s disease is most definitely not juvenile idiopathic arthritis. But government policy doesn’t seem to understand that. I’m a pharmacist, and I started a specialty pharmacy in the small town of Sidney, Neb. My pharmacy patients drive miles and hours across the sun-drenched Nebraska prairie to see me at my pharmacy. They are often overjoyed to arrive at my counter to pick up medications like Rinvoq. No longer do they have to deal with [remote mail-order pharmacies](https://arnoldporter.com/en/perspectives/advisories/2024/07/ftc-interim-staff-report-on-prescription-drug-middlemen) — they can come to my pharmacy anytime to speak with me and pick up their medications for things like Crohn’s disease in person. Advertisement While I am glad to sell my patients their Rinvoq, there is a downside that I never tell them: I sometimes sell them their medications at a [staggering loss to the pharmacy](https://pubs.lib.umn.edu/index.php/innovations/article/view/253). 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