Podcast — Drug Pricing: How Are Payers Responding to the IRA?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 203: Manufacturing Specialty Drugs for Rare Diseases in North Carolina with Paul Testa of Kyowa Kirin
The DEA Is Knocking at Your Door . . . Are You Prepared? – Diagnosing Health Care
The Latest on Healthcare Enforcement
340B Drug Pricing Program Compliance
Podcast: The Legal Battle Over Mifepristone - Diagnosing Health Care
[Podcast] Food for Thought and Thoughts on Food: What to Expect in 2023
Podcast: Post-Dobbs Access to Reproductive Health Care and Abortion-Inducing Drugs - Diagnosing Health Care
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 116: Michael Carlin, Manager, Engage HCP by TrialCard
Hospice Audit Series: Beyond Part D, OIG Scrutinizes the Hospice Industry to the Tune of $6.6 Billion
PODCAST: Williams Mullen's Benefits Companion - New Prescription Drug and Health Coverage Reporting Requirements
I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - Fee Waivers for Small Businesses: Who Qualifies for the Small Business User Fee Waiver for Drugs and Biologics and How to Apply
I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - 2020 Year in Review on FDA’s Enforcement of Rx Drug Promotions & Trends
Part Two: The MFN Drug Pricing Rule and the Rebate Rule: Where Do We Go From Here?
Part One: Two new Medicare Drug Pricing Rules in One Day: What are the MFN and the Rebate Drug Pricing Rules?
On the Ballot 2020: Health Care Policy Outlook - Diagnosing Health Care Podcast
Key Considerations for Reshoring U.S. Drug Manufacturing
I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - Quality Agreements for FDA-Regulated Products: Looking Under the Hood
Product Launching in the Era of COVID-19 - Diagnosing Health Care Podcast
Podcast: Non-binding Guidance: FDA Regulatory and Patent Implications of the Transition Provision of the Biologics Price Competition and Innovation Act
On July 8, 2024, the U.S. Food and Drug Administration (“FDA”) issued a new draft guidance for industry titled, Addressing Misinformation About Medical Devices and Prescription Drugs – Questions and Answers (hereafter,...more
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more
In 2022, the U.S. Food and Drug Administration (FDA or the Agency) issued a total of nine enforcement letters targeting advertising and promotion violations for prescription drugs and devices. A summary of the noteworthy...more
Does anyone remember the 1980’s song, “Freeze-Frame” by The J. Geils Band? A new year, a new Untitled Letter issued by the Food and Drug Administration’s Office of Prescription Drug Promotion to a prescription drug company....more
The Fourth Circuit recently held that the U.S. District Court for the Eastern District of Virginia erred in its analysis of a defendant’s laches defense against an unfair competition claim under Section 43(a) of the Lanham...more
Last week, the U.S. Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) posted two more warning letters for 2020, bringing the tally to five warning and untitled letters for the year. These...more
On August 31, 2020, the Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) sent a Warning Letter to the sponsor of a drug for a violative direct-to-consumer (DTC) radio advertisement.1 The radio...more
Health Canada has instituted numerous measures to help address and combat COVID-19, from facilitating access to COVID-19 products to protecting the public from false or misleading advertisements claiming to prevent, treat or...more
WLG has collaborated with members to present a series of meetings and workshops to connect and educate members during the month of May. The Life Sciences Group will host a webinar "International Regulatory Initiatives to...more
Part of a New Joint Initiative with FTC to Deter Anti-Competitive Practices, Including False or Misleading Comparisons - On February 3, 2020, the U.S. Food and Drug Administration (“FDA”) released draft guidance providing...more
In recent years, the healthcare industry has been turning greater attention to the need to engage or involve patients in developing new technologies and systems to improve healthcare delivery. These patient engagement...more
Foreign-made drugs, nutritional supplements and medical devices imported into the United States with false or misleading labeling or designed to look like an established competing product in violation of the Lanham Act could...more
On May 10, 2019, the Centers for Medicare and Medicaid published a Final Rule on drug pricing transparency in consumer advertisements. ...more
On March 1, 2019, Novartis sued Johnson & Johnson subsidiary Janssen for allegedly presenting false and misleading data about its plaque psoriasis drug Tremfya® (guselkumab). Novartis alleges that its Cosentyx® (secukinumab)...more
MASSACHUSETTS - Massachusetts Supreme Judicial Court Applies “Transient Jurisdiction” Doctrine To Hold Nonresident Individuals’ Intentional, Knowing And Voluntary Presence In Massachusetts At Time Of Service Sufficient To...more
Read the latest news on antitrust, competition, and economic regulation in this summer edition of our quarterly ACER newsletter. ...more
Last summer, we reported on a bizarre verdict in which an Illinois jury levied a $150 million punitive damages award against AbbVie, Inc., the drug company behind AndroGel, without awarding any compensatory damages. As...more
Sen. Hatch Introduces New Bill Regulating Cosmetic Safety - Sen. Orrin Hatch (R-Utah) has introduced legislation aiming to modernize cosmetics regulation, proposing amendments to the Federal Food, Drug and Cosmetic Act...more
In late July, an Illinois jury came to a bizarre verdict in a case over an alleged link between heart attacks and AndroGel, a gel product used for treating low testosterone (or “low T”). The jury found that AbbVie, Inc., the...more
LEGISLATION, REGULATIONS & STANDARDS - FTC Warns Companies and Social Media Influencers on Sponsorship Disclosure - The Federal Trade Commission (FTC) sent 90 letters to companies and social media influencers...more
Implementing unique litigation tactics, on June 15, 2016, Foley & Larder LLP filed a complaint under Section 337 of the Tariff Act at the International Trade Commission (“ITC”) on behalf of Par Pharmaceutical and related...more
Federal prosecutors have wrung $67 million in a settlement with two pharmaceutical companies accused of deceiving doctors to prescribe a drug that the firms knew would be ineffective in treating lung cancer patients....more
Last February, FDA issued three warning letters to companies marketing cannabidiol (CBD) products as dietary supplements. FDA reviewed the companies’ websites and concluded that claims that CBD products could treat...more
For players in the highly regulated pharmaceutical and health care industries, it is common knowledge that manufacturers and distributors of FDA-regulated products are required to promote their products in compliance with the...more
An opinion issued by the U.S. Court of Appeals for the First Circuit on February 20, 2015 held that the Federal Food, Drug, and Cosmetic Act (“FDCA”) preempted claims that Lexapro’s U.S. Food and Drug Administration (FDA)...more