News & Analysis as of

Healthcare Patient Access Pharmaceutical Industry

Carlton Fields

Executive Order Seeks to Build Resilience in Pharmaceutical Supply Chains

Carlton Fields on

On August 13, 2025, President Trump signed an executive order aimed at strengthening America’s pharmaceutical supply chains. Officially titled “Ensuring American Pharmaceutical Supply Chain Resilience by Filling the Strategic...more

Jones Day

HHS Pilot Program to Evaluate 340B Drug Pricing Program Rebate Models

Jones Day on

The Health Resources and Services Administration ("HRSA") plans to implement a limited pilot program that will allow approved manufacturers to issue post-purchase rebates for 340B covered outpatient drugs rather than upfront...more

Quarles & Brady LLP

Manufacturer Rebate Models: The Next 340B Program Battleground

Quarles & Brady LLP on

The 340B Drug Pricing Program (“340B Program”) space continues to be a hive of activity. While 340B stakeholders continue to litigate ongoing manufacturer contract pharmacy restrictions, states legislatures are enacting...more

Troutman Pepper Locke

Second FTC and DOJ Listening Session Focuses on Formulary and Benefit Practices and Regulatory Abuse in the Pharmaceutical...

Troutman Pepper Locke on

On July 24, the Department of Justice (DOJ) and Federal Trade Commission (FTC) held the second of three listening sessions focused on competition in the pharmaceutical marketplace as part of the agency's implementation of the...more

Quarles & Brady LLP

A Prescription for Caution: Senators Release Investigative Report on Direct-To-Consumer Telehealth Models

Quarles & Brady LLP on

On July 17, the offices of Senators Durbin (D. IL.), Warren (D. MA.), Sanders (I. VT.), and Welch (D. VT.) (collectively, “Senators”) released a report summarizing the results of a nine month investigation into...more

Troutman Pepper Locke

FTC Holds Its First Listening Session on Practices and Regulations Impacting Pharmaceutical Generic or Biosimilar Competition

Troutman Pepper Locke on

On June 30, the Department of Justice (DOJ) and the Federal Trade Commission (FTC) held the first of three listening sessions focused on ways to lower Americans’ drug prices through competition. The panels are being held as...more

Jones Day

Medicare's Innovation Center Charts New Direction: Part 3 – Drugs, Devices, and Data

Jones Day on

The Center for Medicare and Medicaid Innovation ("CMMI") is set to reshape value-based care. In the third of a three-part series highlighting this new direction, this summary is focused on CMMI's efforts regarding drugs,...more

Seyfarth Shaw LLP

States Seeking Remedies for the Rising Costs of Prescription Drugs

Seyfarth Shaw LLP on

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

Troutman Pepper Locke

Embattled Biotechs Facing Uncertainty at the FDA Look to Collaborative Deal Structures

Troutman Pepper Locke on

Biotechs have faced several challenging years with slumping valuations and a competitive funding environment. However, the latest slew of retirements and layoffs at the FDA could present their greatest challenge yet....more

Carlton Fields

Executive Order Seeks to Eliminate Discrepancies in Drug Pricing Between United States and Other Countries

Carlton Fields on

President Trump’s highly publicized executive order 14297, titled “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients,” targets the discrepancy in drug pricing in the United States compared with...more

Carlton Fields

Regulatory Relief to Promote Domestic Production of Critical Medicines

Carlton Fields on

President Trump’s May 5, 2025, executive order titled “Regulatory Relief to Promote Domestic Production of Critical Medicines” sets out the administration’s goals to increase the domestic manufacture of critical...more

Quarles & Brady LLP

Arkansas Law Prohibits Pharmacy Benefit Managers from Obtaining or Holding Pharmacy Permits

Quarles & Brady LLP on

On April 16, 2025, Arkansas House Bill 1150 (the “Bill”) was signed by Governor Huckabee Sanders. The Bill will have substantial implications for pharmacy benefit managers (“PBMs”) and pharmacies across the country....more

Jones Day

Constitutional Challenges to Inflation Reduction Act Head to Courts of Appeals

Jones Day on

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

DLA Piper

Keeping Watch on Medicare as the IRA is Implemented: Formulary Management Practices

DLA Piper on

The Inflation Reduction Act (IRA), passed in 2022, made changes to the way drugs are covered and reimbursed in Medicare. While some of the changes taking effect this year could save the government money, beneficiaries may...more

DLA Piper

DEA and HHS Propose Telemedicine Special Registration and Finalize Buprenorphine Telemedicine Prescribing Rules

DLA Piper on

On January 17, 2025, the US Drug Enforcement Administration (DEA) and the US Department of Health and Human Services (HHS) published two rules regarding telemedicine prescribing of controlled substances: a proposed rule...more

Robins Kaplan LLP

Silent Dangers: The Link Between Depo-Provera, Brain Tumors, and Health Inequities

Robins Kaplan LLP on

For decades, Depo-Provera has been presented as a game-changing contraceptive—a quick injection every three months that promised simplicity and effectiveness. For millions of women worldwide, it seemed like the perfect...more

Smart & Biggar

Government of Canada passes Pharmacare Act

Smart & Biggar on

As previously reported, on February 29, 2024, the Minister of Health introduced Bill C-64, An Act respecting pharmacare (Pharmacare Act), which proposed the foundational principles for the first phase of national universal...more

McDermott Will & Schulte

Tirzepatide Shortage Resolved

McDermott Will & Schulte on

On October 3, 2024, the US Food and Drug Administration (FDA) revised its shortage categorization of tirzepatide, a glucagon-like peptide 1 (GLP-1) medication, marking the shortage as “resolved” for all presentations of the...more

Epstein Becker & Green

Medical Diagnostic Equipment Accessibility Regulations Announced by DOJ Under Title II of ADA

Epstein Becker & Green on

To honor the 34th anniversary of the Americans with Disabilities Act (ADA), on July 26, 2024, the U.S. Department of Justice (DOJ) signed a long-awaited final rule to improve access to medical diagnostic equipment (MDE) for...more

Jones Day

NIH Seeks Comments on Patient Access Plan Requirements in Patent License Agreements

Jones Day on

The Situation: The National Institutes of Health ("NIH") proposed a new policy requiring entities that receive licenses from the NIH to certain taxpayer-funded inventions to submit Access Plans for ensuring broader patient...more

McDermott+

Exploring the Virtual Care Policy Landscape One Year Post-PHE

McDermott+ on

May 11, 2024, marked one year since the end of the COVID-19 public health emergency (PHE), and not much has changed in Medicare telehealth policy. We are still operating under temporary waivers and flexibilities and, as a...more

McDermott Will & Schulte

Trending in Telehealth: February 12 – February 26, 2024

Trending in Telehealth highlights state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists and technology companies that deliver and facilitate...more

Dentons

Ep. 4 - Ozempic, Wegovy, and the New Compliance Risks for Providers

Dentons on

Diabetes and obesity drugs have skyrocketed in popularity as of late. According to a report released by Trilliant Health in September 2023, healthcare providers in the United States wrote more than 9 million prescriptions for...more

Polsinelli

New SAMHSA Rule Expands Access to Medications for the Treatment of Opioid Use Disorder

Polsinelli on

On February 2nd, the U.S. Department of Health and Human Services (HHS) released a final rule expanding patient access to medications for the treatment of opioid use disorder (“OUD”). This new final rule implements changes...more

Troutman Pepper Locke

Virginia Advances Toward New Medical Cannabis License Application With New Regulations

Troutman Pepper Locke on

The Virginia Cannabis Control Authority (CCA), which assumed oversight of Virginia’s medical cannabis program from the Board of Pharmacy as of January 1, has promulgated regulations to govern medical cannabis operations in...more

43 Results
 / 
View per page
Page: of 2

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide