News & Analysis as of November 17, 2024

First Amendment › Drug Pricing

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The First Amendment to the United States Constitution prohibits the government from making laws respecting the establishment of religion, prohibiting the free exercise of religion, abridging the freedom of speech or the press, preventing citizens from peacefully assembling, or interfering with citizens' ability to petition the government for redress of their grievances. The First Amendment is one of the most sacred aspects of the American legal tradition and has spawned a vast body of jurisprudence and commentary. less -

Just Opt Out! Boehringer Ingelheim’s IRA Challenge Is Latest To Fail

Kramer Levin Naftalis & Frankel LLP on 7/22/2024

Since its enactment in 2022, the validity of the Inflation Reduction Act (IRA) and its drug price negotiation program (Program) has been repeatedly challenged in District Court, with little success. Boehringer Ingelheim’s...more

Democratic AGs File Amicus Brief Supporting Drug Pricing Transparency Law

Cozen O'Connor on 7/19/2024

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

Federal Court Ruling Suspends Compliance with Certain Reporting Obligations Under Oregon Drug Price Transparency Program

ArentFox Schiff on 2/29/2024

Earlier this month, the US District Court for the District of Oregon issued a declaratory judgment invalidating a key component of the Oregon Drug Price Transparency Program. The Oregon Drug Price Transparency Program was...more

IRA Drug Price Negotiation Program Litigation Updates - Denial of PI Motion and Motion to Dismiss in Chambers of Commerce Case and...

Goodwin on 10/3/2023

Denial of Motion to Dismiss and Motion for Preliminary Injunction in Chambers of Commerce case - On Friday, September 29, the court in Dayton Area Chamber of Commerce et al. v. Becerra et al. (S.D. Ohio, Judge Newman)...more

Medicare Announced First 10 Drugs for Upcoming Price Negotiations

Burr & Forman on 9/5/2023

In 2024, Medicare will, for the first time, have authority under the Inflation Reduction Act passed in 2022 to negotiate drug prices with pharmaceutical manufacturers. On August 29, the Centers for Medicare and Medicaid...more

Legal Battles Continue Over Inflation Reduction Act’s Drug Price Negotiation Measures

MoFo Life Sciences on 7/25/2023

In recent months, six different lawsuits have been filed challenging the Inflation Reduction Act (IRA)’s Drug Price Negotiation Program (the “Program”), with a flurry of activity likely in the coming months before the...more

Merck Sues Federal Government Over Medicare Drug Price Negotiation Program

Knobbe Martens on 6/13/2023

On June 6, 2023, Merck & Co. filed a lawsuit against the U.S. government in federal court over the Inflation Reduction Act (IRA)’s Medicare drug price negotiation program, which allows Medicare to directly negotiate prices...more

HHS Can’t Force Disclosure Of Drug Prices In Ads with “Blunderbuss” Rule

Proskauer - Minding Your Business on 9/11/2020

Among its various attempts to regulate drug prices, the Trump administration recently sought to force pharmaceutical advertisements to disclose the wholesale acquisition cost (WAC) of certain drugs. This effort was dealt a...more

Administration Again Attempts to Lower Drug Prices

Wilson Sonsini Goodrich & Rosati on 8/26/2019

In 2018, the administration published its Blueprint to Lower Drug Prices for U.S. citizens. The Blueprint included 12 proposed actions by the Department of Health and Human Services (HHS)....more

Court Tosses Rule Mandating Drug Price Disclosure in Ads

Manatt, Phelps & Phillips, LLP on 7/24/2019

A Washington, D.C., federal court judge sided with pharmaceutical companies and the Association of National Advertisers (ANA), halting a new rule that mandated the inclusion of the list price, also known as the wholesale...more

Taming Big Pharma profiteering is no snap, White House learns in dual defeats

Patrick Malone & Associates P.C. | DC Injury... on 7/15/2019

It takes more than a lot of huffing and puffing to blow down the ever-rising high costs of prescription drugs, the Trump administration has found. Two defeats happened last week: officials were forced to pull a plan to curb...more

Healthcare Law Update: July 2019

Holland & Knight LLP on 7/10/2019

CMS Regulation - District Court Strikes Down Rule Mandating Price Disclosure in DTC Pharmaceutical Advertisements - The U.S. Department of Health and Human Services (HHS), together with the Centers for Medicare &...more

Federal Judge Strikes Down HHS Drug Pricing Disclosure Rule

Mintz - Health Care Viewpoints on 7/10/2019

In follow-up to our previous post, the pharmaceutical industry gained a win on July 8th when a federal judge struck down the Trump administration’s rule that would have required drugmakers to include list prices for drugs in...more

Pharmaceutical Companies Object to HHS Drug Pricing Disclosure Rule

Mintz - Health Care Viewpoints on 7/2/2019

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

CMS Final Rule Requires Prescription Drug Pricing Transparency in DTC Advertising

Foley Hoag LLP on 5/14/2019

On May 8, 2019, the Centers for Medicare & Medicaid Services (“CMS”) finalized the regulation (“Final Rule” or “DTC Rule”) requiring direct-to-consumer (“DTC”) prescription drug television advertisements to include the...more

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

King & Spalding on 5/14/2019

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

HHS to Require Manufacturers to Disclose Drug Pricing in Television Advertisements

Troutman Pepper on 5/13/2019

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

CMS Finalizes Rule Requiring Disclosure of Drug Prices in TV Ads

Mintz - Health Care Viewpoints on 5/10/2019

Yesterday, May 8, 2019, the Centers for Medicaid & Medicaid Services (“CMS”) released its final rule requiring drug manufacturers to disclose a drug’s wholesale acquisition cost (“WAC”) in direct-to-consumer television...more

A Dialogue With Corporate Counsel: Skadden’s Eighth Annual Pharmaceutical and Medical Device Seminar

Skadden, Arps, Slate, Meagher & Flom LLP on 12/13/2018

On October 30, 2018, Skadden hosted its Eighth Annual Pharmaceutical and Medical Device Enforcement and Litigation Seminar in New York City, which focused on U.S. enforcement issues faced by companies throughout the industry....more

CMS proposes requiring drug prices in TV ads

Hogan Lovells on 10/24/2018

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

Enforcement and Litigation Strategies: Skadden’s Eighth Annual Pharmaceutical, Biotechnology and Medical Device Seminar

Skadden, Arps, Slate, Meagher & Flom LLP on 3/30/2018

On March 15, 2018, Skadden hosted its Eighth Annual Pharmaceutical, Biotechnology and Medical Device Seminar in Palo Alto, California, which focused on U.S. enforcement issues faced by companies throughout the industry. The...more

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First Amendment › Drug Pricing

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