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Drug Pricing Disclosure Requirements Prescription Drugs

Cozen O'Connor

FDA Transparency Push: CRLs Released

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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

Lathrop GPM

Administration Issues Cross-Agency Guidance Targeting Health Care Pricing and Focusing on Hospitals and Health Plans

Lathrop GPM on

On May 22, 2025, the U.S. Department of Health and Human Services, Department of Treasury and Department of Labor (the “Agencies”) announced new steps intended to “strengthen healthcare price transparency.” ...more

Venable LLP

June 1, 2025 Prescription Drug Reporting Deadline for Group Health Plans

Venable LLP on

Employer group health plans must make an annual disclosure of the plan's prescription drug and healthcare spending to the Centers for Medicare & Medicaid Services (CMS). The disclosure, called the Prescription Drug Data...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

IP Hot Topic: Biden Administration Proposes Framework for Exercising Bayh-Dole March-in Rights to Control Drug Pricing

The Biden-Harris Administration recently announced various actions to lower healthcare and prescription drug costs. In one action, the National Institute of Standards and Technology (NIST) released in December 2023 a draft...more

White & Case LLP

2022 Drug Pricing Update: States Continue Legislative Push Even As Congress Passes Long Sought Changes

White & Case LLP on

States remain at the forefront of legislative efforts on a range of issues relating to drug pricing, such as increasing price transparency, capping out-of-pocket costs for insulin, and limiting certain PBM practices. These...more

Fisher Phillips

Departments Delay Enforcement of Transparency Disclosure Requirements

Fisher Phillips on

Group health plan sponsors soon will face daunting new disclosure and transparency requirements under multiple laws including the Affordable Care Act (ACA), the No Surprises Act (the Act) and the Consolidated Appropriations...more

ArentFox Schiff

North Dakota Becomes Latest State to Enact Drug Transparency Law

ArentFox Schiff on

Similar to the laws of several other states, the North Dakota law contains three main disclosure requirements that apply to “drug manufacturers” - The Governor of North Dakota signed House Bill 1032 into law on April 27,...more

Morgan Lewis

DC Circuit Court: CMS Rule on Drug Pricing Disclosure Exceeds Statutory Authority

Morgan Lewis on

In an informative decision for challenging rules that portend government overreach, the US Court of Appeals for the District of Columbia Circuit upholds the invalidation of the Centers for Medicare and Medicare Services’ drug...more

Mintz - Health Care Viewpoints

Federal Appeals Court Affirms Lower Court Ruling: Drug Pricing Transparency Rule Exceeds HHS’s Regulatory Authority

A panel of federal appellate judges has sided with drugmakers by upholding a lower court ruling from 2019 that struck down a regulation proposed by the Department of Health and Human Services (HHS). In a closely watched case,...more

Epstein Becker & Green

DTC Pricing Disclosure Rule Invalidated

Epstein Becker & Green on

On Tuesday June 16th, the U.S. Court of Appeals for the District of Columbia Circuit upheld a District Court decision that invalidated a Department of Health and Human Services (“HHS”) rule requiring pharmaceutical companies...more

Faegre Drinker Biddle & Reath LLP

Will Prescription Drug Price Disclosures Have an Impact?

Colorado Passes New Law - The Colorado General Assembly recently passed new statute C.R.S. 12-42.5-308, which would require pharmaceutical manufacturer marketing employees or agents to present, at the time of marketing a...more

Blank Rome LLP

What’s Happening with Drug Manufacturer Pricing Disclosure Law?

Blank Rome LLP on

After identifying recent federal efforts that would require drug pricing transparency, this article discusses two state laws enacted recently. Thereafter, the article assesses previously enacted state laws requiring drug...more

Mintz - Health Care Viewpoints

Pharmaceutical Companies Object to HHS Drug Pricing Disclosure Rule

Several parties from the pharmaceutical industry have teamed up with an advertising association to file a lawsuit against the Department of Health and Human Services (HHS) to prevent a new drug pricing disclosure rule from...more

Nilan Johnson Lewis PA

Health Plans, PBMs Now on the Clock as Minnesota Enacts New Law for Drug Pricing Transparency

On May 20, 2019, Minnesota Governor Tim Walz signed the Minnesota Pharmacy Benefit Manager Licensure and Regulation Act into law. This law aims to increase transparency regarding how drug prices are set and affords direct...more

McGuireWoods LLP

Direct-to-Consumer Drug Pricing Disclosures Effective July 2019 — 3 Things to Know

McGuireWoods LLP on

U.S. Department of Health and Human Services Secretary Alex Azar announced this month the publication of a Final Rule from the Centers for Medicare & Medicaid Services (CMS) that will require television advertisements for...more

King & Spalding

CMS Issues Final Rule Requiring the Disclosure of Drug List Prices in Direct-to-Consumer Television Ads

King & Spalding on

The Final Rule Requires Manufacturers to Disclose List Prices of Prescription Drugs and Biological Products in Television Advertisements - On May 8, 2019, the U.S. Department of Health and Human Services (HHS or the...more

Sheppard Mullin Richter & Hampton LLP

The New California Regulatory Scheme for Pharmacy Benefit Managers

California recently passed Assembly Bill 315 to create greater regulatory oversight of pharmacy benefit managers (“PBMs”). The bill requires PBMs to provide more transparency regarding their operations. PBMs will have to...more

Akerman LLP - Health Law Rx

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

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

Ogletree, Deakins, Nash, Smoak & Stewart,...

New California Law Aims to Increase PBM Disclosure and Transparency

Employers looking for greater transparency on prescription drug pricing and pharmacy benefit manager (PBM) services will soon have a powerful new tool from an unlikely source: California lawmakers. Under Assembly Bill (AB)...more

BakerHostetler

Capitol Hill Healthcare Update

BakerHostetler on

This week’s “Capitol Hill Healthcare Update” includes the latest on a pending Senate vote on opioid legislation as Congress races to enact a response to the crisis before the November election; the Senate votes to expand...more

Hogan Lovells

U.S. Senate passes bill requiring prescription drug ads to include prices

Hogan Lovells on

On Thursday, the U.S. Senate passed (85-7) the fiscal year 2019 minibus appropriations bill (H.R.6157) that would fund the Departments of Labor, Health and Human Services (HHS), and Education, attaching to it a large...more

Downs Rachlin Martin PLLC

News from the Vermont State House - An analysis from DRM's Government & Public Affairs Team

Equipment Supplier/Dealer Bill Moving in Commerce - A bill that would tip the scales in contract negotiations between farm and yard equipment suppliers and their local dealers has passed the Senate and is now pending...more

Holland & Knight LLP

Massachusetts Legislature Advances Bill to Impose Caps on Drug Prices

Holland & Knight LLP on

The Joint Committee on Health Care Financing of the Massachusetts legislature took up Bill S. 1048, an "Act to promote transparency and cost control of pharmaceutical drug prices," on Sept. 14, 2015. The bill initially was...more

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