Pink Sheet is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


340B Final Rule Keeps Orphan Drug Exclusion Narrow, Counter To Manufacturers’ Request

This article was originally published in The Pink Sheet Daily

Executive Summary

HRSA’s final rule on the exclusion of orphan drugs from 340B discounts says the exclusion applies only to the FDA-designated orphan indication, not all uses of a drug with a rare-disease designation.


Related Content

340B Orphan Drug Rule Vacated, Discount Exemption Applies To All Uses
PhRMA Renews Legal Challenge To 340B Orphan Drug Rule
340B Orphan Drug Rule Overturned In Court, Putting Future Regs Into Question
“The Pink Sheet” – Most Notable Stories Of 2013
Roche Considers Moving Two Drugs Into Phase III, Drops Early-Stage Alzheimer’s Compound In Strong 3rd Quarter
PhRMA Seeking Injunction Against 340B Orphan Drug Exclusion Rule
Perspectives On 340B: An Interview With Lilly’s Derek Asay
340B Orphan Drug Exclusion Seems Untenable, Sen. Hatch Tells HRSA
340B Orphan Drug Rule: Stakeholders Are Parsing ACA Statute – Should Some Indications Be Cheaper Than Others?
HRSA Defines "Orphan Drug" For 340B; Purchasing Prohibition Applies Only To Use In Rare Diseases





Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts