News & Analysis as of

Federal Food Drug and Cosmetic Act (FFDCA) Section 340B Pharmaceutical Industry

ArentFox Schiff

The 340B ‘Saga’ Continued: HRSA, States, and Drug Manufacturers Contest 340B Contract Pharmacy Restrictions in Court

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In 2021, we provided an overview of multiple federal lawsuits challenging the US Department of Health and Human Services (HHS) Health Resources and Services Administration’s (HRSA) enforcement of the 340B Drug Pricing...more

Manatt, Phelps & Phillips, LLP

President Trump Signs Drug Pricing Executive Orders: How Will They Impact Pharma and Providers?

Prescription drug pricing is emerging as one of several healthcare issues that may become a focus of the presidential race as well as contested congressional races this fall. With pending legislative attempts to control drug...more

Foley & Lardner LLP

Health Care Policy Newsletter

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Foley & Lardner LLP’s (“Foley”) Bipartisan Public Policy Team is pleased to share our second “Public Policy Weekly* Health Care Newsletter” in which we compile the latest health care policy news and legislation. Please...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

Foley Hoag LLP

DC District Court Strikes Down 340B Orphan Drug Rule

Foley Hoag LLP on

On May 23, Judge Contreras of the U.S. District Court for the District of Columbia (DC District Court) ruled that the Health Resources and Services Administration (HRSA) did not have the statutory authority to promulgate its...more

Cooley LLP

340B Drug Discount Program Orphan Drug Rule Vacated: ACA “New” Covered Entity Types No Longer Authorized to Purchase Orphan Drugs...

Cooley LLP on

The D.C. District Court permanently enjoined the U.S. Department of Health & Human Services (HHS) Health Resources and Services Administration (HRSA) from implementing its July 23, 2013 final rule on “exclusion of Orphan...more

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