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Regulatory Oversight › Department of Health and Human Services (HHS) › Drug Pricing

Akin Gump Strauss Hauer & Feld LLP

Five FDA Takeaways from the FY26 Budget

Akin Gump Strauss Hauer & Feld LLP on

On May 30, 2025, the Department of Health and Human Services released additional information regarding the Trump administration’s Fiscal Year (FY) 2026 budget request. The release of these FY26 budget materials is timely as...more

Mintz - Health Care Viewpoints

Pharmacy Benefit Managers are on the Federal Government’s Radar: Senate, House, and Agency Proposals Seek to Increase PBM...

Mintz - Health Care Viewpoints on

In conjunction with the surge in state legislative efforts to regulate the pharmacy benefit manager (PBM) industry, Congress and federal agencies have ramped up PBM oversight efforts as part of the ongoing battle to lower...more

McDermott Will & Emery

2020 Starts Off with Two Government Publications Critical of 340B Program Oversight

McDermott Will & Emery on

Less than two weeks into the new year, the federal government has released two new publications addressing concerns related to 340B Program oversight by both state and federal agencies. After a relatively quiet 2019, 340B...more

McDermott Will & Emery

Special Report: FDA 2019 Year in Review

McDermott Will & Emery on

The US Food and Drug Administration’s (FDA’s) 2019 regulatory agenda focused on digital health, streamlined product approvals, evolving evidentiary thresholds for product approvals and strategic enforcement. The agency...more

Hogan Lovells

Will FDA be forced to implement a drug importation program?

Hogan Lovells on

Over a year ago, HHS Secretary Alex Azar requested that FDA establish a working group to explore how drug importation “could help address price hikes and supply disruptions.” The FDA working group was not assigned the task of...more

Troutman Pepper Locke

HHS to Require Manufacturers to Disclose Drug Pricing in Television Advertisements

Troutman Pepper Locke on

U.S. health officials have taken the first concrete step toward implementing the vision set out in the “American Patients First” blueprint published by President Trump and Health and Human Services (HHS) Secretary Alex Azar...more

Hogan Lovells

CMS proposes requiring drug prices in TV ads

Hogan Lovells on

On October 15, CMS released a proposed rule titled “Medicare and Medicaid Programs: Drug Pricing Transparency,” which would require direct-to-consumer (DTC) advertisements for prescription drugs covered by Medicare or...more

Akerman LLP - Health Law Rx

TV Drug Commercials Must Disclose the Drug's List Price if HHS Adopts Proposed Rule

Akerman LLP - Health Law Rx on

We are all familiar with prescription drug television commercials where it sounds like they hired a professional auctioneer to recite the drug side effects so fast you can hardly understand them....more

Bricker Graydon LLP

340B litigation update: Both Ceiling Price Rule delay and 340B rate cuts face legal challenges

Bricker Graydon LLP on

On September 11, 2018, the American Hospital Association (AHA) and other major health care industry groups sued the Department of Health and Human Services (HHS), seeking to have the U.S. District Court for the District of...more

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