News & Analysis as of

Manufacturers Administrative Procedure Act

Beveridge & Diamond PC

Coalition of US States and Cities Lays Groundwork for Legal Challenge of the Department of Energy’s Appliance Efficiency Rollback

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A multistate coalition of twelve state Attorneys General—California, Connecticut, Illinois, Maine, Maryland, Massachusetts, Michigan, Minnesota, New Jersey, New York, Oregon, Vermont, and Washington—joined by the District of...more

Troutman Pepper Locke

Supreme Court Says Affected Retailers May Challenge ENDS Manufacturer’s Marketing Denial Orders

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On June 20, the Supreme Court concluded that marketing denial orders (MDOs) issued by the Food and Drug Administration (FDA) can be challenged not only by the applicants (typically, the manufacturer or importer of the...more

Cozen O'Connor

Democratic AGs Take Aim at ATF’s Decision to Distribute Firearm Triggers

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A group of 16 Democratic AGs filed a lawsuit in federal court challenging the decision by the Bureau of Alcohol, Tobacco, Firearms, and Explosives (ATF) to redistribute thousands of Forced Reset Triggers (FRTs) throughout the...more

Oberheiden P.C.

10 Critical Facts for Defense Logistics Agency (DLA) Contractors Facing Suspension or Debarment

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The Defense Logistics Agency (DLA), is cracking down on procurement fraud and contract fraud. It has recently issued multiple referrals for suspension or debarment, and it is targeting not only prime vendors, but...more

Baker Donelson

HHS Previews Guidance Addressing Implementation of 340B Rebate System

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In the fall of 2024, several pharmaceutical companies reacted to HRSA's decision to prevent them from implementing a rebate model for their respective 340B Programs by filing lawsuits against HHS and HRSA claiming that the...more

Knobbe Martens

U.S. Supreme Court Defers to Agency Decision-Making in FDA’s Denial of Premarket Approval of Flavored E-Cigarette Products

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We previously reported a decision by the U.S. Food and Drug Administration (FDA), denying the premarketing authorization of several flavored e-cigarette product. On April 2, 2025, the Supreme Court of the United States...more

Baker Donelson

HHS and HRSA Defend 340B Discount Model Against Pharma Rebate Plan

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Summary of Changes - In the fall of 2024, several pharmaceutical companies – specifically, Eli Lilly and Company, Sanofi-Aventis U.S. LLC, Bristol Myers Squibb Company, and Novartis Pharmaceuticals Corporation – reacted to...more

Miller Starr Regalia

Fifth District Affirms Judgment Rejecting CEQA/APA Challenges to CARB’s Approval of ZEV Truck Sales Mandate Regulation; Holds...

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In an opinion filed August 27 and later ordered published on September 24, 2024, the Fifth District Court of Appeal affirmed a judgment denying a writ petition that challenged the State Air Resources Board’s (CARB) adoption...more

Troutman Pepper Locke

FDA Says Agency Will Enforce the Cigarette Graphic Warning Rule in December 2025, But Pending Litigation Could Still Derail Those...

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In September, the U.S. Food and Drug Administration (FDA) told industry that it would begin enforcing the agency’s cigarette graphic warning rule in December 2025 in an enforcement policy outlined in a short guidance...more

Troutman Pepper Locke

Industry Urges SCOTUS to Consider FDA Graphic Cigarette Warnings

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In August, a group of tobacco companies filed a petition for certiorari at the U.S. Supreme Court, seeking review of a lower court’s holding that the First Amendment does not prohibit the U.S. Food and Drug Administration...more

Mintz - Health Care Viewpoints

CMS 2026 IRA Price Negotiations Results Likely to Create Upstream and Downstream Effects

On August 15, 2024, CMS announced the results of the first round of the negotiated prices between CMS and participating drug manufacturers for the 10 selected drugs under the Inflation Reduction Act’s (IRA) Medicare Drug...more

Mintz - Health Care Viewpoints

Federal Judge Rejects Pharma Manufacturers’ Challenge to Negative OIG Advisory Opinion

A Virginia Federal Judge recently rejected a challenge to a negative Advisory Opinion issued by the Department of Health & Human Services’ Office of Inspector General (OIG) that disapproved of a proposal where certain...more

Bass, Berry & Sims PLC

Government Appeals Decisions in 340B Contract Pharmacy Litigation

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On December 28, 2021, the federal government submitted notices to appeal three federal district court decisions related to the use of contract pharmacies under the federal 340B drug pricing program. The appeals are the latest...more

Foley & Lardner LLP

Court Sides with Drug Manufacturers in Ongoing 340B Litigation

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Over the last year, covered entities participating in the 340B Drug Pricing Program (340B Program) have anxiously monitored a flurry of litigation that could determine the scope of the 340B Program. The litigation and related...more

Bricker Graydon LLP

Federal court sides with Eli Lilly challenge to HHS expansion of 340B discounts

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On March 16, 2021, the United States District Court in Indiana granted plaintiff Eli Lilly’s request for a preliminary injunction to halt implementation of a Department of Health and Human Services (HHS) rule published in...more

Sheppard Mullin Richter & Hampton LLP

Contract Pharmacies and the 340B Drug Discount Program: New Litigation and an Advisory Opinion Point to Ongoing Skirmishes on the...

On December 11, 2020, five hospital groups, including the American Hospital Association (“AHA”), and an organization of hospital pharmacists representing participants in the 340B drug pricing program (“340B Program”), filed a...more

Akin Gump Strauss Hauer & Feld LLP

What's New In Washington - September 2018

Following a truncated August recess, the House and the Senate returned to Washington after Labor Day with a full plate of legislative items to address prior to the end of the fiscal year on September 30. That list includes...more

Holland & Knight LLP

Court of Appeals for the D.C. Circuit Denies Petition Seeking Review of FAA Airworthiness Directive

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The District of Columbia Circuit Court of Appeals recently upheld a Federal Aviation Administration (FAA) decision to publish an airworthiness directive ordering the removal of certain cylinder assemblies used in piston...more

Williams Mullen

Environmental Notes - July 2016

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CONGRESS FINDS THE FORMULA TO REFORM CHEMICAL REGULATION - The Toxic Substance Control Act (TSCA) is the primary federal law by which the manufacture, import and use of chemical substances are regulated in the United...more

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