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First Amendment › Pharmaceutical Industry

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... more +
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 -
Cozen O'Connor

Democratic AGs File Amicus Brief Supporting Drug Pricing Transparency Law

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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

Wolf, Greenfield & Sacks, P.C.

A Look Ahead: Key Intellectual Property Legal Topics in 2024

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What should in-house counsel be on the lookout for in 2024? As we begin a new year, our attorneys look ahead at intellectual property topics they expect will be trending in 2024. They cover areas including life sciences,...more

McDermott Will & Emery

[Webinar] 2024 IP Outlook: Trends Affecting Patent, Trademark, Copyright and Trade Secret Holders - December 12th, 1:00 pm - 2:00...

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As 2023 draws to a close, new developments continue to emerge across the patent, trademark, copyright and trade secret spaces. Join members of McDermott’s Intellectual Property Group for a year-end review that will explore...more

Dechert LLP

FDA Issues Revised Draft Guidance on “Off-Label” Communications to Health Care Providers – Expanded Scope, Yet Limitations Remain

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The FDA issued Revised Draft Guidance addressing communications by drug and device manufacturers about “off-label” uses of approved products. The Revised Draft Guidance supersedes FDA’s 2014 Draft Guidance on...more

Goodwin

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

Goodwin on

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

Burr & Forman

Medicare Announced First 10 Drugs for Upcoming Price Negotiations

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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

American Conference Institute (ACI)

[Event] 41st FDA Boot Camp - September 20th - 21st, Boston, MA

American Conference Institute (ACI) on

ACI’s FDA Boot Camp is back in Boston! This essential training course – now in its 41st iteration – continues to provide the working knowledge of core essentials of FDA law and regulation, including the new amendments under...more

MoFo Life Sciences

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

MoFo Life Sciences on

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

Knobbe Martens

Merck Sues Federal Government Over Medicare Drug Price Negotiation Program

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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

American Conference Institute (ACI)

[Virtual Conference] FDA Boot Camp - September 14th - 15th, 8:15 am - 1:30 pm EST

American Conference Institute (ACI) on

Through nearly 19 years, ACI’s FDA Boot Camp has been the training grounds for life sciences attorneys and executives to master the fundamentals of FDA regulation. Don’t miss your opportunity to join their ranks....more

Skadden, Arps, Slate, Meagher & Flom LLP

FDA’s Final Rule on Intended Use: ‘Getting Right Back to Where We Started From’

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On August 2, 2021, the U.S. Food and Drug Administration (FDA) issued its final rule amending the intended use regulations codified at 21 CFR 801.4 and 21 CFR 201.128, marking the end of an effort FDA began in 2015. While the...more

Foley Hoag LLP

New Intended Use Rule Finalized

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On August 2, 2021, the Food and Drug Administration (FDA) published its final intended use rule (the “Final Rule”). The Final Rule amends FDA’s regulations describing the types of evidence relevant to determining a product’s...more

Fox Rothschild LLP

Veterinary Medicine, Pet Products And Cannabis

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As a veterinarian, if a pet-owner comes to you with questions or concerns about the safety of hemp or CBD infused pet products, are you prepared to navigate the conversation? Practicing veterinarians are subject to the...more

Troutman Pepper

FDA Proposes Modified “Intended Use” Regulations

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In its latest effort to provide direction and clarity to regulated industry and stakeholders, on September 23, the U.S. Food and Drug Administration (FDA) published a proposed rule and preamble amending its medical product...more

Troutman Pepper

Did Congress Intend to Criminalize Off-Label Promotion? One District Judge Suggests the Issue Is Ripe for Review

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A judge in the District of Massachusetts recently questioned whether Congress intended to criminalize off-label promotion through misbranding and adulteration statutes. In an order denying a Rule 29 motion brought by two...more

Proskauer - Minding Your Business

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

Proskauer - Minding Your Business on

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

Robins Kaplan LLP

Financial Daily Dose 8.12.2020 | Top Story: 9th Circuit Reversed Antitrust Ruling Against Qualcomm

Robins Kaplan LLP on

Big win for Qualcomm this week, with a 9th Circuit panel reversing an antitrust verdict against the company that “had threatened the chip maker’s business model.” The appellate court, in flipping the district court’s ruling,...more

Wilson Sonsini Goodrich & Rosati

Administration Again Attempts to Lower Drug Prices

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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

Manatt, Phelps & Phillips, LLP

Court Tosses Rule Mandating Drug Price Disclosure in Ads

Manatt, Phelps & Phillips, LLP on

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

Patrick Malone & Associates P.C. | DC Injury...

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

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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

Holland & Knight LLP

Healthcare Law Update: July 2019

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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

Mintz - Health Care Viewpoints

Federal Judge Strikes Down HHS Drug Pricing Disclosure Rule

Mintz - Health Care Viewpoints on

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

Mintz - Health Care Viewpoints

Pharmaceutical Companies Object to HHS Drug Pricing Disclosure Rule

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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

Foley Hoag LLP

CMS Final Rule Requires Prescription Drug Pricing Transparency in DTC Advertising

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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

King & Spalding

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

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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

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