News & Analysis as of

Administrative Procedure Act Inflation Reduction Act (IRA)

Goodwin

Third Circuit Affirms Rejection of AstraZeneca’s Challenges to IRA Drug Price Negotiation Program

Goodwin on

On May 8, 2025, the Court of Appeals for the Third Circuit affirmed the district court’s dismissal of AstraZeneca’s challenges to the Inflation Reduction Act’s Drug Price Negotiation Program and CMS’s Guidance implementing...more

Mintz - Health Care Viewpoints

Appeals Court Rejects AstraZeneca’s Challenge to Medicare Drug Price Negotiation Program

A federal appellate court has handed down the first appellate-level decision addressing the merits of drug manufacturers’ challenges to the Inflation Reduction Act of 2022's (IRA) Medicare Drug Negotiation Program...more

Jones Day

Constitutional Challenges to Inflation Reduction Act Head to Courts of Appeals

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No legislation has garnered more attention in the life sciences industry in recent past than the so-called Drug Price Negotiation Program of the Inflation Reduction Act (the "Program"). ...more

Cozen O'Connor

Democratic AGs Sue Over Access to Clean-Energy Funds

Cozen O'Connor on

A group of four Democratic AGs sued the EPA and Citibank, N.A., as a financial agent for the federal government, alleging that they wrongfully denied the states access to funds appropriated by Congress for clean-energy...more

Ballard Spahr LLP

White House Pauses Federal Funding Under Inflation Reduction Act and Infrastructure Investment and Jobs Acts

Ballard Spahr LLP on

On January 20, 2025, the White House issued an Executive Order titled Unleashing American Energy. Citing the detrimental effect of “ideologically motivated regulations,” the Order broadly establishes a new executive energy...more

Bracewell LLP

The Trump Administration’s Day-One Executive Actions: Impacts on Energy and Environmental Policy and More

Bracewell LLP on

On January 20, 2025, President Trump re-assumed the presidency with a flurry of executive orders and memoranda, many of which directly impacted energy and environmental issues. These orders included a production-minded...more

Mintz - Health Care Viewpoints

EnforceMintz — Medicare Advantage and Part D Programs to Remain in the Enforcement Spotlight in 2025

As government scrutiny and enforcement targeting the Medicare Advantage (Medicare Part C) program continued in 2024, the industry’s response to agency actions escalated. Last year also resulted in the first sizable Part D...more

Vinson & Elkins LLP

Outlook on the New Administration: EPA’s Environmental Agenda in the Energy Sector

Vinson & Elkins LLP on

During the 2024 campaign, President-elect Donald Trump promised his supporters that he would direct federal agencies on day one to “immediately remove every single burdensome regulation driving up the cost of goods.” For the...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

Akin Gump Strauss Hauer & Feld LLP

Happy Birthday Two You, IRA: Drug Pricing Dynamics to Watch as Maximum Fair Price Announcements Loom

This week marks the second anniversary of the enactment of the Inflation Reduction Act, a partisan law that ushered in sweeping Medicare price setting reforms. The Biden-Harris Administration is poised to announce the first...more

Knobbe Martens

Medicare Drug Price Negotiation Program Steadily Progressing Despite Lawsuits

Knobbe Martens on

The Biden Administration’s Inflation Reduction Act (IRA)’s Medicare drug price negotiation program, which allows Medicare to directly negotiate prices with drugmakers, has faced several legal challenges....more

King & Spalding

A Brief Overview of the Federal Rulemaking Process in the United States

King & Spalding on

Since the enactment of the Inflation Reduction Act of 2022 (the “IRA”) in the United States, the Department of the Treasury (“Treasury”) and the Internal Revenue Service (“IRS”) have issued notices of proposed regulations...more

Goodwin

Court Grants Summary Judgment Ending AstraZeneca’s Lawsuit Challenging the IRA

Goodwin on

Today, the district court for the District of Delaware (Judge Connolly) granted the government’s motion for summary judgment on all claims brought by AstraZeneca in its Complaint challenging the Drug Price Negotiation Program...more

Holland & Knight LLP

Appeals Court Restores Offshore Oil, Gas Lease Sale Without Rice's Whale Protections

Holland & Knight LLP on

The U.S. Court of Appeals for the Fifth Circuit on Nov. 14, 2023, dismissed claims brought by environmental groups challenging offshore oil and gas Lease Sale 261. The court ordered that the sale take place within 37 days of...more

Goodwin

IRA Drug Price Negotiation Program Litigation Updates - Denial of PI Motion and Motion to Dismiss in Chambers of Commerce Case and...

Goodwin on

Denial of Motion to Dismiss and Motion for Preliminary Injunction in Chambers of Commerce case - On Friday, September 29, the court in Dayton Area Chamber of Commerce et al. v. Becerra et al. (S.D. Ohio, Judge Newman)...more

Mintz - Health Care Viewpoints

Mintz IRA Update — Legal Challenges to the Medicare Drug Price Negotiation Program

As discussed throughout this Update, the implementation of the Medicare Drug Price Negotiation Program (the “Negotiation Program” or “Program”) has been subject to a number of legal challenges. To date, six manufacturers and...more

McDermott Will & Emery

Weekly IRS Roundup December 26 – December 30, 2022

Presented below is our summary of significant Internal Revenue Service (IRS) guidance and relevant tax matters for the week of December 26, 2022 – December 30, 2022...more

Holland & Knight LLP

'Tis the Season … to Reopen Public Comment on SEC's Share Buyback Rule Proposal?

Holland & Knight LLP on

The SEC announced on Dec. 7, 2022, a second reopening of the public comment period for its proposed Share Repurchase Disclosure Modernization rule (Rule), first proposed on Dec. 15, 2021. The initial 45-day comment period was...more

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