False Claims Act Insights - Bitter Pills: DOJ Targets Pharmacies for FCA Enforcement
Taking the Pulse: A Health Care & Life Sciences Video Podcast | Episode 239: Understanding the 340B Pricing Program with Chuck Melendi of Disruptive Dialogue
Navigating Legal Strategies for Covering GLP-1s in Self-Insured Medical Plans — Employee Benefits and Executive Compensation Podcast
Evolving AI Legislation: Federal Policies, Task Forces, and Proposed Laws — The Good Bot Podcast
Podcast - Hot Topics in FDA Regulation: GLP-1s, LDTs, AI and More
Podcast — Drug Pricing: 2025 J.P. Morgan Healthcare Conference Takeaways and Outlook
Prescribing GLP-1 Medications: Be Aware of Legal Limitations
AI and Pharmacovigilance Under the FDA's New Emerging Drug Safety Technology Program – The Good Bot Podcast
Podcast — Drug Pricing: What’s in the New CMS Medicaid Final Rule?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 216: Patient Advocacy and Healthcare Policy Change with Melissa Horn of the Arthritis Foundation
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 214: Pharma Manufacturing in North Carolina with Ed Hernandez of Eli Lilly
Podcast — Drug Pricing: Takeaways From the Chicago Medicaid Drug Rebate Program Summit
Podcast — Drug Pricing: How the Demise of Chevron Deference and Other Litigation May Impact the Pharmaceutical Industry
Understanding Pharmacy Benefit Managers: The PBM Landscape Explained
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
In part two of this three-part series on the Attorney General Alliance (AGA) 2025 Annual Meeting, we highlight panelists’ discussions on the safety and regulation of GLP-1 medications and the role of attorneys general in...more
The authors were thinking of the Beatles’ 1963 song, “Not a Second Time,” when we read the latest Warning Letter from the Food and Drug Administration’s Office of Prescription Drug Promotion. The company received a Warning...more
On February 20, 2025, U.S. Senators Dick Durbin (D-IL) and Roger Marshall, M.D. (R-KS) introduced bipartisan legislation, the Protecting Patients from Deceptive Drug Ads Act (the Act), which closes perceived “legal loopholes”...more
Celebrity Endorsements - As companies continue to seek effective advertising strategies, celebrity endorsements remain a powerful tool, particularly in reaching broad and receptive audiences through social media platforms....more
The U.S. Food and Drug Administration (FDA) is facing pressure from Congress and the medical community to enhance its oversight of online prescription drug advertising. The pressure comes amidst growing concerns about social...more
Social media usage worldwide is showing no signs of slowing as it permeates all aspects of our daily lives. Originally published in Law360 - September 11, 2023....more
On August 11, 2023, the Office of Prescription Drug Promotion (OPDP) of the U.S. Food and Drug Administration (FDA) issued an untitled letter to Exeltis USA Inc. (Exeltis) regarding a promotional social media sponsored post...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
President Trump has stormed past accepted professional practices and triggered alarms about ethical decision making by caregivers, as he persists in his noisy advocacy for treating seriously ill patients with Covid-19...more
ACI is delighted to present our inaugural Think Tank on Rx Drug Advertising and Promotion. Attend this intimate and in-depth symposium where the “who’s who” of pharmaceutical advertising and promotion will gather to discuss...more
When Kim Kardashian speaks, the FDA listens. Or, more precisely, when Kardashian, who has 46.8 million followers on Instagram, posts an enthusiastic endorsement—and advertisement—on the social media platform for Diclegis, a...more
This week might have been the first time that an FDA regulatory issue hit the headlines on TMZ and other “celebrity watcher” websites. In an August 7 Warning Letter sent to the drug company Duchesnay, Inc., FDA complains...more
The Food and Drug Administration (FDA) is reopening the comment period for two draft social media guidances in response to requests for additional time to allow interested persons to submit comments. Beginning September 29,...more
The Food and Drug Administration (FDA) recently promulgated two much-anticipated draft guidance documents on the use of social media to present information about prescription drugs and medical devices. The draft guidance...more
On June 17, 2014, the U.S. Food and Drug Administration (FDA or the Agency) issued two draft guidance documents, providing recommendations for two types of communication over internet and social media platforms. The first...more
On June 17, 2014, the FDA issued two draft guidance documents relating to the use of social media and the Internet to promote prescription drugs and medical devices. The FDA described how a company should use a character...more
Last week the Food and Drug Administration (FDA) promulgated two much-anticipated draft guidance documents on using social media to present information about prescription drugs and medical devices. The draft guidance...more
In recent years, guidance by the U.S. Food and Drug Administration ("FDA" or "Agency") for industry on the use of social media has continued to evolve in incremental steps, but the pharmaceutical and medical device industries...more
The U.S. Food and Drug Administration (FDA) recently released draft guidance that paves the way for regulated companies to harness the power of social media. This draft guidance addresses how FDA-regulated manufacturers,...more