News & Analysis as of

HRSA Orphan Drugs Food and Drug Administration (FDA)

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

McGuireWoods Consulting

Washington Healthcare Update - May 2021 #4

This week in Washington: Talks continue on infrastructure, Senate committees moving forward on health legislation, President’s budget due the end of the week....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

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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