Public Health Service Act

News & Analysis as of

FDA’s Proposal for Naming Biosimilars Pleases Some, Disappoints Others

The Biologics Price Competition and Innovation Act of 2009 (BPCIA) created an abbreviated pathway for the approval of biosimilar biological products, but is silent on how to name them. The nonproprietary naming of...more

FDA Releases Long-Awaited Biological Naming Draft Guidance and Proposed Rule

On August 27, 2015, the U.S. Food and Drug Administration (FDA) released long-awaited and highly anticipated draft guidance regarding the non-proprietary naming of biological products, including biosimilars. The draft...more

House Hearings to Focus on ACA Insurance Issues

On September 9, 2015, the House Energy and Commerce Committee is holding a hearing on H.R. 1624, Protecting Affordable Coverage for Employees Act of 2015. The legislation would amend the Public Health Service Act to redefine...more

FDA’s Proposed Naming Convention for Biologics

On August 27, 2015, the Food and Drug Administration (FDA) released draft guidance on nonproprietary naming of biological products. The agency’s draft guidance proposes that the core nonproprietary name for originator...more

The ERISA Litigation Newsletter - July 2015

Editor's Overview - This month's article by Lindsey Chopin discusses Affordable Care Act ("ACA") litigation. Just five years old, the Supreme Court has considered issues related to the ACA numerous times. Two of those...more

Washington Healthcare Update

This Week: CMS Releases Guidance on Fast Track Process for 1115 Waivers for Medicaid and CHIP... CEO Sends Letter to State Insurance Commissioners Concerning 2016 Premium Decisions... Medicare Board of Trustees...more

HRSA Issues 340B Drug Discount Program Civil Money Penalty Proposed Rule

On June 17, 2015, the Health Resources and Services Administration (HRSA) issued a proposed rule to implement civil money penalty (CMP) provisions added to section 340B of the Public Health Service Act as part of the...more

Supplemental Excepted Benefits? “It depends.”

Last week, HHS, along with the Department of Labor and the Treasury, provided long overdue guidance regarding the third category of supplemental “excepted benefits” as defined by Section 2791 of the Public Health Services...more

ODAC Committee Votes to License Sandoz’s Zarxio®

As noted in our previous client alert, FDA Accepts First Biosimilar Application Filed under Section 351(k) of the Public Health Service Act, Sandoz Inc. (“Sandoz”) filed the first biosimilar application under the Biologics...more

NIH Issues Proposed Rule Expanding Clinical Trial Registration and Reporting Obligations

On November 21, 2014, the National Institutes of Health (“NIH”) published a notice of proposed rulemaking regarding requirements for clinical trial registration and the reporting of results (“Notice” or “Proposed Rule”)....more

The Affordable Care Act—Countdown to Compliance for Employers, Week 3: Group Health Plan, Cafeteria Plan and Health FSA...

As applicable large employers grapple with the Affordable Care Act’s (ACA) employer shared responsibility (pay-or-play) rules, two questions arise with notable frequency...more

Sandoz and Celltrion Decline the Invitation to Dance: Biosimilars Challenge the Applicability of the BPCIA’s Exchange Provisions...

In our blog post of November 18, 2013 (“No Avoiding BPCIA For Biosimilars: No Patent Declaratory Judgment Before Biosimilars Application is Filed”), we discussed the decision of the U.S. District Court for the Northern...more

Left without a Partner: Amgen Sues Sandoz for Refusing to Dance in Accordance with BPCIA Patent Procedures

There has been a lot of curiosity within the biologics industry regarding how the “patent dance” procedures of the Biologics Price Competition and Innovation Act (“BPCIA”) would operate. This interest was piqued in July 2014...more

FDA Publishes "Purple Book" for Biosimilars

FDA Publishes "Purple Book" to Catalog Biologics, Interchangeable and Biosimilar Products - The US Food and Drug Administration (“FDA”) recently published its first “Lists of Licensed Biological Products with Reference...more

FDA Accepts First Biosimilar Application Filed under Section 351(k) of the Public Health Service Act

Biologics are large molecules made from, derived from, or extracted from a natural source such as a human, animal, or microorganism that are used in the treatment, diagnosis, or prevention of disease. Biologics include...more

HHS Issues Interpretive Rule Excluding Orphan Drugs from 340B Program Discounts Only for Designated Orphan Status Uses

On July 21, 2014, the Health Resources and Services Administration of HHS (HRSA) issued an interpretive rule interpreting Section 340B(e) of the Public Health Service Act as excluding from the 340B Drug Pricing Program orphan...more

The Affordable Care Act—Countdown to Compliance for Employers, Week 34: When Can Carriers Impose Minimum Participation and Minimum...

Commencing with plan and policy years beginning on or after January 1, 2014, the Affordable Care Act amends the Public Health Service Act (“PHS Act”) to make three important changes to the rules governing health insurance...more

D.C. Circuit Court of Appeals Upholds FDA Oversight of Autologous Stem Cell Therapeutics

A company that developed a stem cell-based therapy for treating diseases and conditions was found to be in violation of the federal Food, Drug, and Cosmetic Act for failing to seek approval for its product. Cellular and...more

HRSA Publishes Orphan Drug Rule for 340B Program

Rule requires most manufacturers to change government pricing methodologies, calculations, and systems. On July 23, the Health Resources and Services Administration (HRSA) of the U.S. Department of Health and Human...more

Benefit Issues in Puerto Rico: Impact of the ACA, ERISA and the PBGC

This article highlights some recent developments that employers with Puerto Rico employee benefits arrangements should consider concerning compliance with U.S. federal laws on health care reform and the Patient Protection and...more

A Primer on “Low-Cost” Group Health Plans

A May 10 Wall Street Journal article, “Employers Eye Bare-Bones Health Plans Under New Law” (see the associated video on WSJ Live), highlighted a compliance strategy to minimize employer exposure for assessable payments under...more

Consumer Driven Health Care 2.0: Are Private Health Insurance Exchanges the New ‘Killer App’?

Originally published in Tax Management Weekly Report on 11/05/2012. In a September 27, 2012, front page article, the Wall Street Journal reported that Sears Holdings Corp. and Darden Restaurants, Inc., had adopted a...more

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