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Constitutional Challenges Prescription Drugs

Goodwin

Health Headlines: July 2025

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Welcome to the sixth issue of Health Headlines, a newsletter created by lawyers in our Healthcare practice....more

ArentFox Schiff

Investigations Newsletter: Johnson & Johnson Challenges the Constitutionality of FCA $1.6 Billion Verdict

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Johnson & Johnson Challenges the Constitutionality of FCA $1.6 Billion Verdict - Following a record $1.6 billion jury verdict for off-label promotion of HIV drugs Prezista and Intelence, Johnson & Johnson (J&J) subsidiary...more

Mintz - Health Care Viewpoints

Federal Court Issues Preliminary Injunction Against Iowa PBM Law, Citing ERISA Preemption and First Amendment Violations

On July 21, 2025, the U.S. District Court for the Southern District of Iowa issued a comprehensive preliminary injunction blocking enforcement of key provisions of Iowa Senate File 383 (the Act), a sweeping law aimed at...more

Latham & Watkins LLP

Senators Introduce Legislation to Restrict Direct-to-Consumer Drug Advertising

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On June 12, 2025, Senators Bernie Sanders (I-Vt.) and Angus King (I-Maine) introduced the End Prescription Drug Ads Now Act, with Senators Chris Murphy (D-Conn.), Peter Welch (D-Vt.), Jeff Merkley (D-Ore.), and Dick Durbin...more

Brownstein Hyatt Farber Schreck

The First Amendment and Direct-to-Consumer (DTC) Prescription Drug Ads

Department of Health and Human Services Secretary Robert F. Kennedy, Jr. has made no secret of his disdain for television advertisements for prescription drugs. As a presidential candidate, he promised to ban those ads by...more

Goodwin

Health Headlines: June 2025

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Welcome to the seventh issue of Health Headlines, a newsletter created by lawyers in our Healthcare practice. Iowa Governor Kim Reynolds signed Senate File 383 into law, placing new restrictions on pharmacy benefit...more

Smart & Biggar

Health Canada must redetermine exemption requests for psilocybin (magic mushroom)-assisted psychotherapy training

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TheraPsil, a patient advocacy organization, and 73 healthcare practitioners (HCPs) have succeeded in the Federal Court of Appeal (FCA) to overturn the refusal of the Minister of Mental Health and Addictions and Associate...more

Mintz - Health Care Viewpoints

PBMs Sue Arkansas Over Restrictive PBM Ownership Law

On April 16, 2025, Arkansas enacted Act 624 (the Act), an unprecedented law prohibiting pharmacy benefit managers (PBMs) from owning or operating pharmacies in the state. As we discussed in our May 2025 blog post, the law’s...more

Seyfarth Shaw LLP

States Seeking Remedies for the Rising Costs of Prescription Drugs

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As expected, the lawsuits have commenced following the enactment of the Arkansas legislation prohibiting pharmacy benefit managers (PBM’s) from owning or operating actual pharmacies within the state. Michigan has filed its...more

Goodwin

Prescription Drug Affordability Review Boards - 2025 Update

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Prescription Drug Affordability Boards (PDABs) are becoming a larger part of the state drug price regulatory landscape. The boards are regulatory bodies that review the affordability and cost of specific prescription drugs. ...more

Goodwin

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

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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

McDermott Will & Schulte

No Supremacy Clause Preemption Where State Statute Doesn’t Conflict With Federal

The US Court of Appeals for the Fifth Circuit explained that ordinarily, when state law contradicts with federal law, the state law may be preempted by the federal law under the US Constitution’s Supremacy Clause. However,...more

ArentFox Schiff

District Court Dismisses Manufacturer Lawsuit Challenging Colorado Price Setting for Prescription Drug

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There are currently six states with active Prescription Drug Affordability Boards (PDABs) — Colorado, Maryland, Washington, Oregon, New Hampshire, and Minnesota....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

Mintz - Health Care Viewpoints

Mintz IRA Update — A Circuit Win and the End of Chevron Deference Could Shift Tides in Drug Price Negotiation Program Challenges

As detailed in our previous updates, the IRA’s Medicare Drug Price Negotiation Program (the Negotiation Program or Program), which enables the federal government to negotiate prices for some of the costliest Medicare Part D...more

Morgan Lewis

Manufacturers Challenge CMS’s Definitions of ‘QSSD’ and ‘Bona Fide Marketing'

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Drug manufacturers remain steadfast in their efforts to challenge the constitutionality of the Inflation Reduction Act’s mandatory price negotiation provisions. Recently filed suits contend that CMS has impermissibly expanded...more

Ropes & Gray LLP

2024 FDA Enforcement Review: Quality and Transparency Remain Critical Concerns

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The U.S. Food and Drug Administration (“FDA”), in partnership with the Department of Justice (“DOJ”), pursued significant and, in some cases, precedent-setting enforcement actions in 2024. The government continued to...more

Hall Benefits Law

Fifth Circuit Rules ACA Preventive Mandate Remains in Effect Nationwide – Except as to Plaintiffs

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The U.S. Court of Appeals for the Fifth Circuit has ruled in favor of Christian-owned businesses and individuals who sued over the Affordable Care Act (ACA) preventive care mandates. The appellate Court agreed with 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

Burr & Forman

Medicare Announced First 10 Drugs for Upcoming Price Negotiations

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In 2024, Medicare will, for the first time, have authority under the Inflation Reduction Act passed in 2022 to negotiate drug prices with pharmaceutical manufacturers. On August 29, the Centers for Medicare and Medicaid...more

BakerHostetler

The CMS List of Selected Drugs: Developing Effective Arguments for Pricing of Selected Drugs Under the Inflation Reduction Act of...

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On Aug. 29, the Centers for Medicare & Medicaid Services (“CMS”) issued the inaugural list of drugs selected for price setting under the Inflation Reduction Act of 2022 (IRA). Those selected drugs are Eliquis, Jardiance,...more

Hogan Lovells

Restrictions on Lawyer Ads Involving Drugs and Medical Devices Are Not Unconstitutional, Says Federal Court

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The Fourth Circuit has found that a West Virginia state law restricting how attorneys can solicit clients in pharmaceutical and medical device cases does not violate the First Amendment. At the end of April, a three-judge...more

WilmerHale

District Court Enjoins California's Unprecedented "Reverse Payment" Law

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On December 8, 2021, a federal district court granted a preliminary injunction temporarily enjoining enforcement of the California state law Preserving Access to Affordable Drugs, which attempts to sanction reverse-payment...more

McGuireWoods Consulting

The Courts and Healthcare Policy - August 2021

The courts continue to play an important role in health policy. 2020 saw several notable lawsuits related to the Affordable Care Act (ACA). Several other Trump administration policies were challenged, including Medicare...more

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