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
Cigna filed a lawsuit on June 24 in Manhattan federal court accusing Bristol Myers Squibb of unlawfully blocking generic versions of its blood cancer drug, Pomalyst, from entering the market. The suit also names Celgene, a...more
President Trump’s executive orders and legislative proposals from Congress leverage FDA to help lower drug prices, address anti-competitive practices, and accelerate generic drug approvals....more
In a first-of-its-kind move, Arkansas Governor Sarah Huckabee Sanders has enacted legislation prohibiting pharmacy benefit managers ("PBMs") from owning or operating pharmacies within the state. The law—Act 624—takes effect...more
On April 16, 2025, Arkansas Governor Sarah Huckabee Sanders signed into law House Bill 1150, now Act 624 (the Act), making Arkansas the first state in the nation to prohibit pharmacy benefit managers (PBMs) from acquiring or...more
This week, the FTC continued its intense regulatory focus on pharmaceutical patents listed in the FDA’s Orange Book. As reported in earlier editions of The Interplay, the FTC issued a policy statement in September 2023,...more
On January 23, the U.S. Court of Appeals for the Second Circuit affirmed a district court ruling that Martin Shkreli, CEO of Vyera Pharmaceuticals (Vyera), violated federal and state laws by engaging in illegal and...more
On June 30, 2023, a jury in the Northern District of California found Gilead and Teva not liable in a trial accusing the companies of engaging in an illegal reverse payment to delay generic versions of two HIV drugs, Truvada...more
The Competition Director General has issued a precedent-setting determination against the pharmaceutical marketing company MBI Pharma Ltd. (MBI). The Director General determined that MBI abused its monopolistic position and...more
Late last week, Regeneron Pharmaceuticals, Inc. filed an antitrust complaint against Amgen Inc. in the U.S. District Court for the District of Delaware. Regeneron alleges that “Amgen is engaged in a persistent exclusionary...more
Each year, Americans spend more than $1,500 per person on prescription drugs. Critics calling for measures to lower prescription drug costs often cast blame on alleged abuses of patent and competition laws. To address these...more
Major shakeup at Ford, where CEO Jim Hackett is out after a three-year stint in which he “achieved mixed results” but didn’t impress Wall Street enough to keep his job. Ford has installed COO James Farley, a Toyota alum who’s...more
The European Court of Justice's ruling in Paroxetine, handed down in record time just before Brexit, confirms the narrow interpretation of restrictions by object given in other recent cases. It also clarified certain issues...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
On January 15, 2020, the Romanian Competition Council fined fined Roche Romania SRL €12.9 million ($14.2 million) following two investigations into what the Competition Counsel found to be Roche’s anti-competitive practices...more
On 30 January 2020, the Court of Justice of the European Union (CJEU) issued its decision on a request for preliminary ruling submitted by the UK Competition Appeal Tribunal (CAT) in a case concerning the long-standing...more
The Department of Justice (DOJ) announced this month that it obtained over $3 billion in settlements and judgments from civil fraud and false claims cases during the fiscal year ending September 30, 2019 (FY 2019). Of this...more
A new California law, Preserving Access to Affordable Drugs, AB-824 (the Act), which is aimed at curbing reverse-payment patent settlements, took effect on January 1. The Act codifies a presumption that any transfer of value...more
A group of three major drug distributors—McKesson, AmerisourceBergen, and Cardinal Health—are in the midst of talks with representatives of state and local governments who have brought more than 2000 opioid-related lawsuits...more
The Third Circuit recently held in In re Remicade (Direct Purchaser) Antitrust Litigation that a direct purchaser’s antitrust suit alleging overpayment for a drug purchased pursuant to a distribution agreement with a...more
A decade ago, the European Commission conducted a thorough sectoral inquiry into the European pharmaceutical sector that identified antitrust shortcomings impeding access to more affordable and innovative medicines and...more
On Tuesday, December 4, the Federal Trade Commission (FTC) announced that it had submitted a comment regarding the Food and Drug Administration’s (FDA) revised draft guidance on citizen petitions. ...more
Read the latest news on antitrust, competition, and economic regulation in this summer edition of our quarterly ACER newsletter. ...more
The 340B Drug Pricing Program has spawned two antitrust lawsuits related to CVS’s acquisition of Wellpartner, a 340B administrator. 340B administrators contract with 340B covered entities (e.g., hospitals) to provide a...more
On July 18, 2018, after months of alluding to the various aspects of an upcoming “Biosimilar Action Plan” as another prong within FDA’s broader Drug Competition Action Plan (DCAP), FDA finally unveiled its plan for...more
On 14 August 2017, the National Development and Reform Commission ("NDRC") released a draft of the Guidelines on Pricing Conduct by Business Operators for Drugs in Shortage and Active Pharmaceutical Ingredients ("Draft...more