News & Analysis as of

Department of Health and Human Services (HHS) Prescription Drugs PHRMA

Axinn, Veltrop & Harkrider LLP

One Down, Eight to Go: Texas Judge Dismisses Medicare Drug Price Case – Will Others Follow?

A domino has fallen, but the question remains whether there are more to come. On February 12, 2024, the U.S. District Court for the Western District of Texas dismissed a challenge to the Department of Health and Human...more

Goodwin

Court Dismisses PhRMA Lawsuit Challenging IRA

Goodwin on

Today, the district court for the Western District of Texas granted the government’s motion to dismiss the lawsuit brought by PhRMA and other organizations challenging the Drug Price Negotiation Program of the Inflation...more

Mintz - Health Care Viewpoints

Mintz IRA Update — A Deeper Dive into Other Controversies of the IRA’s Medicare Drug Price Negotiation Program

The ability to directly negotiate drug prices has been a policy goal for Democrats for many years and was recently accomplished through the Inflation Reduction Act’s (“IRA”) Medicare Drug Price Negotiation Program (the...more

ArentFox Schiff

Drug Manufacturers Take Note: Updated PhRMA Code Released

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The Pharmaceutical Research and Manufacturers of America (PhRMA) – a leading lobbying and advocacy group for drug manufacturers – has released an updated version of its “Code on Interactions with Health Care Professionals”...more

Blank Rome LLP

Under Biden Administration, Will Federal Drug Pricing Transparency Efforts Continue to Outpace State Laws?

Blank Rome LLP on

During 2019 and 2020, states enacted fewer laws requiring drug manufacturers to disclose pricing and related information. Initially, the slowdown may have been due to federal actions to rein in drug prices through the Trump...more

Baker Donelson

Lawmakers Call on HHS to Stop Drug Companies from Denying 340B Drug Pricing

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Members of Congress of both parties are requesting that the Department of Health and Human Services (HHS) take action to ensure that providers participating in the 340B drug pricing program can continue to receive discounted...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

K&L Gates LLP

What a Trump Administration Could Mean for the 340B Drug Program

K&L Gates LLP on

A Republican White House and a Republican-run Congress could bring significant changes to the 340B Drug Pricing Program (“the 340B program”). Many in Washington believe that the new administration and Republicans in Congress...more

McGuireWoods LLP

Washington Healthcare Update

McGuireWoods LLP on

This Week: Congress unable to come to agreement on funding the government past Dec. 11 so a short-term funding bill was passed to give more time for negotiations... Tax extenders still being discussed as a vehicle for a...more

K&L Gates LLP

340B Orphan Drug Interpretive Rule Struck Down by D.C. District Court: HHS and HRSA Lose In Second Round of Litigation Over 340B...

K&L Gates LLP on

In an Opinion issued October 14, 2015, D.C. District Court Judge Rudolph Contreras granted Pharmaceutical Research and Manufacturers of America’s (“PhRMA”) motion for summary judgment against the U.S. Department of Health and...more

BakerHostetler

D.C. District Court Deals Blow to HHS 340B Program Interpretive Rule

BakerHostetler on

Court says Congress has the power to make the change that HHS attempted with its Interpretive Rule, and thus it should be left to the legislative branch. A lawsuit challenging the Interpretive Rule, filed by the...more

King & Spalding

D.C. District Court Rules Drug Manufacturer Group Must File New Lawsuit To Challenge HHS Interpretive Rule on 340B Orphan Drug...

King & Spalding on

On August 27, 2014, the United States District Court for the District of Columbia rejected Plaintiff Pharmaceutical Research and Manufacturers of America’s (PhRMA) request to invalidate HHS’s recent interpretive rule...more

Polsinelli

Polsinelli Podcasts - Confusion to Clarity on the Future of the 340B Program

Polsinelli on

Polsinelli Podcast Explores Upcoming Webinar Covered entities and drug manufacturers expected the Health Resources and Services Administration (HRSA) to issue its much anticipated mega-reg for the 340B Program in June....more

BakerHostetler

The Orphan Drug Wars: HHS Interpretive Rule Clarifies Orphan Drug Exclusion

BakerHostetler on

On July 21, 2014, the U.S. Department of Health and Human Services (HHS) released an “Interpretive Rule” in response to a recent U.S. District Court decision that vacated the July 23, 2013, orphan drug rule on the grounds...more

Baker Donelson

HHS to Continue Enforcing Orphan Drug Exclusion from 340B Program

Baker Donelson on

The Department of Health and Human Services (HHS) through its Office of Health Resources and Services Administration (HRSA) announced last week that, although a court recently struck down its regulation addressing application...more

Polsinelli

Recent 340B Orphan Drug Decision May Have Widespread Implications

Polsinelli on

In This Issue: - Orphan Drug Rule Background - PhRMA Sues to Block the Orphan Drug Rule - District Court Says HHS Overstepped Its Authority and Invalidates Orphan Drug Rule - Implications on the “Mega-Reg” ...more

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