News & Analysis as of

Federal Food Drug and Cosmetic Act (FFDCA) HRSA Department of Health and Human Services (HHS)

ArentFox Schiff

The 340B ‘Saga’ Continues: As More States Pass 340B Contract Pharmacy Laws, More Lawsuits Follow

ArentFox Schiff on

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

ArentFox Schiff

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

ArentFox Schiff on

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

Alston & Bird

Health Care Week in Review: CMS Finalizes Rules on Nursing Home Staffing Standards and Medicaid Access and Quality; FTC Bans Most...

Alston & Bird on

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Alston & Bird

Health Care Week in Review: HHS Finalizes 340B ADR Rule; House and Senate Hold Hearings on President’s FY 2025 HHS Budget

Alston & Bird on

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Alston & Bird

Health Care Week in Review: CMS Announces Data RFI to Improve Medicare Advantage Transparency; Senate Finance Committee Releases...

Alston & Bird on

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Alston & Bird

Health Care Week in Review: FDA Released Its User Fee Amendments For FY 2023

Alston & Bird on

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...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

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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