News & Analysis as of September 19, 2024

Patient Protection and Affordable Care Act (PPACA) › Federal Food Drug and Cosmetic Act (FFDCA)

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The Patient Protection and Affordable Care Act (PPAC), also known as Obamacare, is a United States federal statute passed in March of 2010. The Act creates a nationwide insurance system and provides federal... more +

What the Supreme Court's "Chevron Deference" Ruling Could Mean for Health Care Law

Baker Donelson on 6/26/2024

Baker Donelson recently published Anticipating SCOTUS Ruling on Chevron Deference – What to Know and Five Ways to Prepare explaining the United States Supreme Court's upcoming ruling which is expected to impact the regulatory...more

FDA Seeks to Increase Regulatory Oversight of Laboratory Developed Tests

ArentFox Schiff on 10/25/2023

On October 3, the US Food and Drug Administration (FDA) issued a proposed rule regarding the regulation of in vitro diagnostic products (IVDs). In this proposed rule, the FDA announced its intent to amend its regulations to...more

Health Care Policy Newsletter

Foley & Lardner LLP on 5/14/2018

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

A&B Healthcare Week in Review

Alston & Bird on 1/31/2017

On January 9, 2017, the Food and Drug Administration (FDA) issued a draft guidance entitled, Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers: Questions and Answers; Draft...more

Basics of the BPCIA

Womble Bond Dickinson on 11/21/2016

The FDA broadly defines biologics as medical products derived from living sources (human, animal, plant, or microorganism) intended to treat or prevent diseases. Biologics thus include such varied vehicles of medical...more

Washington Healthcare Update

McGuireWoods LLP on 10/18/2016

1. Congress - Senate - FDA Supports Expanded Authority Over Cosmetics - In an Oct. 5 letter to Senator Dianne Feinstein (D-CA), the Food and Drug Administration (FDA) says its current legal authority over...more

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

BakerHostetler on 10/26/2015

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

DC District Court Strikes Down 340B Orphan Drug Rule

Foley Hoag LLP on 6/7/2014

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

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

Cooley LLP on 5/27/2014

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

IRS Releases Final Rule on Medical Device Tax

King & Spalding on 12/18/2012

Last week, the IRS and the Treasury Department published final regulations regarding the medical device excise tax under § 4191 of the Internal Revenue Code (IRC). IRC § 4191, which was enacted by the Health Care and...more

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Patient Protection and Affordable Care Act (PPACA) › Federal Food Drug and Cosmetic Act (FFDCA)

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