Tag: Orphan Drugs

User Fee Reauthorization Picks Up Steam

In preparation for a vote this week, the House of Representatives Committee on Energy and Commerce yesterday released a new draft of the user fee reauthorization.  The bill, titled the “FDA Reauthorization Act of 2017,” contains several new sections to align with user fee legislation passed by the Senate in […]

PhRMA Challenges HRSA Interpretative Rule on Orphan Drugs in the 340B Drug Discount Program

On October 9, 2014, the Pharmaceutical Research & Manufacturers of America (“PhRMA”) filed a lawsuit seeking to enjoin the Health Resources Services Administration (“HRSA”) from implementing its July 23, 2014 “Interpretive Rule” regarding orphan drugs in the 340B Drug Discount Program (the “2014 Interpretive Rule”).  PhRMA’s lawsuit alleges that the 2014 […]

HRSA Stands By Its Interpretation of 340B Drug Discount Program Orphan Drug Availability, Despite Court Decision Vacating Regulation

The U.S. Department of Health & Human Services (HHS) Health Resources and Services Administration (HRSA) published today a statement responding to the recent court decision vacating the 340B Drug Discount Program Orphan Drug Rule.  As we previously reported, the D.C. District Court permanently enjoined HRSA from implementing its July 23, 2013 […]

340B Drug Discount Program Orphan Drug Rule Vacated:  ACA “New” Covered Entity Types No Longer Authorized to Purchase Orphan Drugs Under the 340B Program, Regardless of Indications

[UPDATE 6/18/2014: HRSA has issued a statement that it continues to stand by its interpretation of ACA permitting new covered entities to purchase orphan drugs under the 340B program for non-orphan use. See our more recent post for updated information.] The D.C. District Court permanently enjoined the U.S. Department of Health & Human […]

HRSA Finalizes 340B Drug Discount Program Orphan Drug Rule – 340B Discounts Available to New Covered Entities for Non-Orphan Indications

On June 22, 2013, the Health Resources and Services Administration (“HRSA”) released its final rule on the exclusion of orphan drugs for certain covered entities under the 340B Drug Discount Program.  The advance copy is currently available for viewing at the Office of the Federal Register Public Inspection Desk, and […]