News & Analysis as of

Final Rules Prescription Drugs Manufacturers

Quarles & Brady LLP

Part D Pharmacies Required to Enroll in Data Exchange Module to Help Drug Price Negotiation Cash Flow Issue

Quarles & Brady LLP on

On April 15, 2025, the Centers for Medicare & Medicaid Services (“CMS”) published the Contract Year 2026 Policy and Technical Changes Final Rule which amends the regulations governing various Medicare programs, including the...more

Morgan Lewis - As Prescribed

Balancing Safety and Accessibility: FDA Broadens Approval Pathway for Nonprescription Drugs by Finalizing the ‘ACNU’ Rule

The US Food and Drug Administration (FDA) has announced a final rule expanding the approval pathway for nonprescription drug products by allowing the approval of a nonprescription drug product with an “Additional Condition...more

Jones Day

Canadian Drug Importation May Undermine Intellectual Property Protection

Jones Day on

The Situation: Earlier this year, Florida became the first state to receive authorization for its Section 804 Importation Program ("SIP") from the U.S. Food and Drug Administration ("FDA"). This initial step toward the legal...more

ArentFox Schiff

New ADR Rule to Govern Disputes Between 340B Covered Entities and Drug Manufacturers

ArentFox Schiff on

Disputes between 340B Drug Pricing Program-covered entities and the drug manufacturers required to sell outpatient drugs to those entities at discounted prices will be governed by an alternative dispute resolution (ADR)...more

Foley & Lardner LLP

FDA’s Final Rule on Direct-to-Consumer Advertising – Presentation of Risk Information

Foley & Lardner LLP on

In November 2023, the U.S. Food and Drug Administration (FDA) published its final rule (Rule) to amend its regulations concerning radio and television direct-to-consumer (DTC) advertisements (ads) for human prescription drugs...more

Bass, Berry & Sims PLC

Federal District Court Vacates Copay Accumulator Adjustment Rule: Programs Remain the Same for Now

Bass, Berry & Sims PLC on

On May 17, the U.S. District Court for the District of Columbia issued a decision vacating the Accumulator Adjustment Rule, regulations issued by the Centers for Medicare and Medicaid Services (CMS) in December 2020 as part...more

Foley Hoag LLP - Medicaid and the Law

The 340B Contract Pharmacy Saga Continues

Donald Trump extended two directives restricting the admission of certain immigrants and nonimmigrants to the U.S. Specifically, Presidential Proclamation (PP) 10014 restricting the admission of first-time immigrants and PP...more

King & Spalding

HHS Finalizes Rule Challenging Drug Manufacturer Rebates to PBMs and Payors

King & Spalding on

Final Rule Closely Resembles Previously Withdrawn 2019 Proposed Rule - INTRODUCTION - On November 20, 2020, as part of a release of several drug pricing rules, the U.S. Department of Health and Human Services (“HHS”)...more

Verrill

No More Waiting: 340B Drug Pricing Program Pharma Oversight and Enforcement Rule To Be Effective January 1, 2019

Verrill on

The U.S. Department of Health and Human Services (“HHS”) recently published a final rule on the 340B Drug Pricing Program (“340B Program”), moving the effective date for changes to the program up to January 1, 2019. Making...more

Holland & Knight LLP

340B Drug Pricing Program Final Rule Delayed … Again

Holland & Knight LLP on

In a notice published on June 5, 2018, the Health Resources and Services Administration (HRSA) announced that the January 2017 340B Drug Pricing Program final rule (the “Final Rule”) will again be delayed. The Final Rule,...more

Hogan Lovells

Current good manufacturing practice requirements for combination products

Hogan Lovells on

On January 11, 2017, the U.S. Food and Drug Administration (FDA) issued a final guidance document entitled “Current Good Manufacturing Practice Requirements for Combination Products.”[1] This guidance describes and explains...more

Hogan Lovells

FDA Clarifies “Intended Use” Regulations: Knowledge Alone ≠ Intent, But Knowledge Certainly Can Be One Element in...

Hogan Lovells on

In its January 9, 2017 final rule addressing when tobacco products may be regulated as drugs, devices, or combination products, the Food and Drug Administration (“FDA” or “The Agency”) amended the intended use regulations for...more

Morgan Lewis

The CMS Final Covered Outpatient Drug Rule Addresses Many Industry Concerns

Morgan Lewis on

The rule implementing the Medicaid Drug Rebate Program is less burdensome and costly than what was originally proposed. In 2010, the Affordable Care Act (ACA) directed the US Centers for Medicare and Medicaid Services...more

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