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
This chart tracks the date, drug, reference-listed company, applicant, and indications of publicly available drug launches resulting from Abbreviated New Drug Applications and 505(b)(2) Applications....more
On December 31, 2024, the New Jersey Department of Banking & Insurance (“Department”) issued two Bulletins, announcing changes to the law, effective January 1, 2025. Both Bulletins addressed health insurance. Bulletin, No....more
A bipartisan coalition of 50 states, D.C., and two territories reached settlements with Heritage Pharmaceuticals, Inc. and Apotex Corp. to resolve allegations of price fixing generic drugs in violation of the Sherman Act....more
The Supreme Court of California is gearing up to decide an important question for the future of product liability law: Do drug manufacturers have a duty to innovate? In other words, does a manufacturer of a non-defective drug...more
It has been a busy year for issues related to drug pricing, and with the election around the corner, litigation issues that have been developing over the last few years are likely to be a key focus for the second half of...more
Clients often ask if a law firm can represent both brand and generic drug manufacturers. It’s a reasonable question, particularly when the popular perception is that potential conflicts pigeonhole law firms, forcing them to...more
Given its growing role as the “pharmacy to the world,” FDA Commissioner Robert Califf, M.D., recently took a trip to India and offered some of his (and FDA's) views upon his return. During his visit, Commissioner Califf met...more
A federal court in Florida has dismissed all claims—without leave to amend—against all generic ranitidine and store-brand manufacturers in the multidistrict litigation over the heartburn medication Zantac and its generic...more
Some product liability suits are dead on arrival. At least, that is the position the Fifth Circuit took late last week in affirming the dismissal of a pro se plaintiff’s suit against a collection of generic and brand-name...more
The Federal Circuit’s October 2020 split decision in GSK v. Teva made waves throughout the pharmaceutical industry and among Hatch-Waxman litigators. In the broadest reading, some see the majority opinion as rendering any...more
On Wednesday, July 15, the House Energy and Commerce (E&C) Committee advanced several bills to the House floor that demonstrate continued interest in health policy matters other than the COVID-19 pandemic. The Fairness in...more
On Monday, in the much-anticipated decision in Acetris Health, LLC v. U.S. 18-2399, the Court of Appeals for the Federal Circuit (the “Federal Circuit”) ruled that U.S. manufacture of a drug is sufficient to confer U.S....more
When Big Pharma insists its sky-high prices are justified, patients may want to keep in mind key findings just revealed about prescription drugs and their makers...more
The SPC Manufacturing Waiver (the "Waiver") is now in force, effective from 1 July 2019 (Regulation 2019/933 amending the SPC Regulation 2009/469). The Waiver has been introduced with the stated aim of putting EU generic and...more
In a trio of recent decisions arising out of cases alleging that an antipsychotic medication, Risperdal, and its generic, risperidone, had caused gynecomastia (breast tissue growth) in men, the United States District Court...more
With Big Pharma pressing the limits in promoting and pricing prescription medications, patients and their advocates long have hoped that generic drugs might be difference-makers on costs and practices. Those positive wishes,...more
Recently, the United States Food and Drug Administration (FDA) Commissioner Scott Gottlieb issued a statement (the statement) outlining a new policy to improve access and foster price competition for branded drugs that are...more
On 15 November 2018 the Joint Procurement Office (the JPO) published its Paper on Centralized Drug Procurement in “4+7” Cities (the Paper), which launched the national pilot scheme for tendering with minimum procurement...more
With the opportunity for global pharmaceutical companies to gain new access to the Chinese market presenting itself like never before, significant news broke on December 7, 2018, regarding a newly implemented pilot...more
Five years after the U.S. Supreme Court found in FTC v. Actavis, 570 U.S. 136 (2013), that large and unjustified payments from a brand pharmaceutical manufacturer to prevent generic entry can provide a basis for an antitrust...more
Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more
On March 16, 2018, Massachusetts joined a growing minority of states — California, Vermont and Illinois — recognizing innovator liability of name-brand drug manufacturers. Rafferty v. Merck & Co., Inc., SJC-12347, 2018 WL...more
Today, the Massachusetts Supreme Judicial Court made an important ruling concerning innovator liability with respect to pharmaceuticals. Though precluding negligence and traditional product liability claims against brand-name...more
On Wednesday, November 8, 2017 the Federal Trade Commission (FTC) hosted a workshop seeking to explore the general question of why the cost of prescription drugs has risen greatly in recent history. The Workshop was framed...more
As prescription drug pricing continues to dominate political headlines, state legislatures are taking action intended to lower drug prices for health plans and patients. Despite industry opposition, California has enacted a...more