News & Analysis as of

Transparency Pharmaceutical Industry Drug Pricing

Cozen O'Connor

FDA Transparency Push: CRLs Released

Cozen O'Connor on

On July 10, 2025, citing a drive to increase transparency, the Food and Drug Administration (“FDA”) published more than 200 complete response letters (CRLs) previously issued to companies that had submitted new drug...more

Ropes & Gray LLP

FDA Commissioner Makary Promises “Real Time” Release of Complete Response Letters: Can FDA Really Do That?

Ropes & Gray LLP on

On July 10, 2025, in the name of embracing “radical transparency,” the U.S. Food and Drug Administration (“FDA”) announced that it was publishing more than 200 complete response letters (“CRLs”) issued in response to drug and...more

Akin Gump Strauss Hauer & Feld LLP

FDA Opens the Vault on Decision Letters—Releases Wave of Drug and Biologic CRLs

This morning, the U.S. Food and Drug Administration (FDA) announced the publication of more than 200 decision letters, also known as complete response letters (CRLs), with plans to release more from the archives. The CRLs...more

Mintz - Health Care Viewpoints

Massachusetts Aligns with National Trends and Enacts Sweeping Legislation to Regulate Pharmaceutical Benefit Managers

On the heels of a nationwide push to regulate pharmacy benefit managers (PBMs), Massachusetts enacted a landmark piece of legislation to increase transparency and oversight within the pharmaceutical supply chain, specifically...more

Groom Law Group, Chartered

This Week From the Hill (January 12 – 18, 2025)

Each week while Congress is in session, our Policy team delivers a key update to highlight a topical benefits, health, or retirement news item from the Hill, such as a newly introduced bill, a summary of a committee hearing,...more

McDermott Will & Schulte

Post-Election Outlook: Issues to Watch for Pharmacy Industry Stakeholders

The 2024 election results will create significant tailwinds for Republican legislative and regulatory priorities in US Congress, federal agencies, and state houses across the country. This On the Subject considers the outlook...more

Cozen O'Connor

NJ Adopts More Transparent Prescription Drug Pricing

Cozen O'Connor on

New Jersey AG Matthew Platkin announced the adoption of new rules designed to promote greater transparency in prescription drug pricing. The new rules implement recently enacted legislation intended to control prescription...more

Cozen O'Connor

Democratic AGs File Amicus Brief Supporting Drug Pricing Transparency Law

Cozen O'Connor on

A group of 21 Democratic AGs filed an amicus brief with the U.S. Court of Appeals for the Ninth Circuit supporting Oregon in its defense of H.B. 4005, which requires pharmaceutical manufacturers to report certain information...more

Wiley Rein LLP

Proposed State and Federal PBM Legislation: Is There Reason for Action Now?

Wiley Rein LLP on

Legislation aiming to reform the regulation of pharmacy benefit managers (PBMs) remains on the horizon on both the federal and state levels. In particular, 2023 was a fertile year for PBM legislative initiatives....more

Morgan Lewis - As Prescribed

California’s Revised Prescription Drug Price Transparency Regulations Effective April 1

Effective April 1, 2024, California will expand its existing prescription drug price transparency requirements by enacting legislation to amend and clarify requirements on wholesale acquisition cost increase reporting and...more

Sheppard Mullin Richter & Hampton LLP

Oregon Prescription Drug Price Transparency Act in Limbo

On February 16, the U. S. District Court for the District of Oregon struck down the state’s drug price transparency law—The Prescription Drug Price Transparency Act (the “Act”)—ruling that the Act’s annual price increase...more

Wiley Rein LLP

Health Care AI and Drug Prices: Highlights From Two Senate Hearings

Wiley Rein LLP on

Health Care was a hot topic in the U.S. Senate on February 8, as two important Senate Committees – the Committee on Finance and the Committee on Health, Education, Labor, and Pensions (HELP) – held hearings, respectively, on...more

Quarles & Brady LLP

The Lower Costs More Transparency Act of 2023

Quarles & Brady LLP on

The Lower Costs More Transparency Act of 2023, passed by the House 320-71 on Monday, December 11, 2023, would institute new transparency and pricing rules on pharmacy benefit managers (PBMs) and hospitals. The bill would...more

Goodwin

2023 State Drug Transparency Law Development Update

Goodwin on

In October 2021, we reported on an uptick in the passage of state drug price transparency legislation. As an update to that report, as of October 2023, approximately 22 states have now passed drug price transparency laws...more

McDermott+

McDermottPlus Check-Up: September 8, 2023

McDermott+ on

CONGRESS - House Republicans Release Healthcare Package. On September 6, House Republicans unveiled the Lower Costs, More Transparency Act, a draft package of healthcare transparency provisions, pharmacy benefit manager...more

McDermott+

Drug Payment Reform and Transparency: It’s What’s on the Menu for Policymakers

McDermott+ on

August 31, 2023 – When it comes to prescription drug costs, policymakers have set their focus on the consumer: “Let’s lower drug prices for the consumer.” “Let’s give consumers more options in paying their out-of-pocket...more

White & Case LLP

Where Things Stand on Drug Pricing at the Halfway Point of 2023

White & Case LLP on

While only slightly past the midway point of 2023, it has already been a busy year for developments in drug pricing. Notably, CMS released its final guidance in preparation for price negotiations and the first 10 drugs...more

Morgan Lewis

New Jersey Latest to Join States Signing Drug Price Transparency Reporting Measures into Law

Morgan Lewis on

Following in the footsteps of other states, New Jersey’s state legislature has recently signed into law three bills for containing prescription drug costs. One bill—Senate Bill 1615—is likely to have a particularly sweeping...more

Maynard Nexsen

Pharmacy Benefit Managers: The Market Demands Transparency and Perhaps a Whole Lot More

Maynard Nexsen on

Pharmacy Benefit Managers (PBMs) have recently been facing increased scrutiny and negative attention. PBMs first formed in the late 1960’s and were originally designed to negotiate drug prices with drug manufacturers on...more

McDermott+

Healthcare Preview for the Week of: May 1, 2023

McDermott+ on

Lots of Healthcare Activity in Congress - Activity in Congress focusing on healthcare issues has increased over the last few weeks and is not slowing down anytime soon. This week, the Senate Health, Education, Labor, and...more

Blank Rome LLP

Nevada Publishes 2023 Drug Price Transparency Lists

Blank Rome LLP on

On January 31, 2022, the Nevada Department of Health and Human Services (“DHHS”) released its annual drug lists in accordance with its Drug Transparency Reporting Program. DHHS published four drug lists: List #1 Essential...more

Goodwin

Year in Review: Top U.S. Biosimilars-Related Regulatory Developments of 2021

Goodwin on

As 2021 comes to a close, Big Molecule Watch reviews the top five biosimilar regulatory developments of the year... President Biden Signs Orange Book Transparency Act - In January, we reported that President Biden...more

MoFo Life Sciences

Biden Administration Executive Order On Promoting Competition In The American Economy: Drug Pricing And Healthcare Industry...

MoFo Life Sciences on

On July 9, 2021, President Biden enacted a sweeping executive order creating a “whole‑of-government competition policy.” Morrison & Foerster outlined the administration’s policy in a recent client alert that provides a...more

McDermott Will & Schulte

Agencies Issue Final Employer Healthcare Price Transparency Rule

McDermott Will & Schulte on

On October 29, 2020, the US Departments of Health and Human Services, Labor and Treasury (collectively, the Departments) issued the Transparency in Coverage final rule (the Rule), along with a fact sheet, setting forth...more

Holland & Knight LLP

Court of Appeals Affirms Judgment that Struck Down Rule Mandating Price Disclosure in Pharmaceutical Ads

Holland & Knight LLP on

Holland & Knight's July 2019 Healthcare Law Update reported on a decision by the U.S. District Court for the District of Columbia that struck down a final rule promulgated by the U.S. Department of Health and Human Services...more

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