News & Analysis as of

Food and Drug Administration (FDA) Section 340B Orphan Drugs

Latham & Watkins LLP

Healthcare Life Sciences Drug Pricing Digest - July 2025

Latham & Watkins LLP on

On July 4, 2025, President Trump signed into law the One Big Beautiful Bill Act, his signature policy legislation. Two aspects of this legislation are particularly relevant for drug pricing....more

Mintz - ML Strategies

Health Care Update - October 2015

Mintz - ML Strategies on

Senate Working Group Pressing Forward on Telehealth - As Congress focuses on bigger picture policy decisions, including broad budget negotiations and raising the debt ceiling, there are some exciting developments on the...more

BakerHostetler

D.C. District Court Deals Blow to HHS 340B Program Interpretive Rule

BakerHostetler on

Court says Congress has the power to make the change that HHS attempted with its Interpretive Rule, and thus it should be left to the legislative branch. A lawsuit challenging the Interpretive Rule, filed by the...more

Troutman Pepper

District Court Rules Pharmaceutical Manufacturers Are Not Required to Discount Orphan Drugs - Regardless of the Condition Being...

Troutman Pepper on

HHS’ rule requiring pharmaceutical manufacturers to discount orphan drugs when they were used to treat non-rare diseases was inconsistent with Congress’ intent to exclude all orphan drugs from the 340B discount program for...more

McDermott Will & Emery

Federal Court Rejects HHS Interpretation of 340B Program’s Orphan Drug Rule

McDermott Will & Emery on

On October 14, 2015, the United States District Court for the District of Columbia (the Court) issued a decision in Pharmaceutical Research and Manufacturers of America v. United States Department of Health and Human...more

King & Spalding

HHS Says It Has Authority to Issue Interpretive Guidance on Contested 340B Orphan Drug Rule Despite Court Order Vacating Final...

King & Spalding on

According to a recent court filing by HHS, the agency should not be precluded from issuing interpretative guidance regarding a provision of the 340B Drug Pricing Program even though a federal district court previously vacated...more

Mintz - Health Care Viewpoints

HRSA “Interprets” Its Enjoined 340 Orphan Drug Rule into Effect

In January, I predicted that 2014 would be a game-changer for the 340B Drug Discount Program, in part because of HRSA’s announcement that, in June 2014, it would for the first time publish an omnibus rule governing 340B...more

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