Food, Drugs, Healthcare, Life Sciences

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Welcome to the Mondaq Food, Drugs, Healthcare, Life Sciences homepage, here you will find thought leadership articles, podcasts, videos and webinars providing insights covering topics such as Food and Drugs Law, Healthcare, Life Sciences, Biotechnology and Nanotechnology.
Article
Eli Lilly’s Retatrutide Lawsuits: What Pharmacies, Telemedicine Companies And Online Retailers Need To Know
Eli Lilly has filed five lawsuits targeting companies selling products containing retatrutide, an unapproved investigational peptide. The cases challenge online retailers using "research use only" disclaimers, weight loss clinics, and med spas, alleging their marketing practices and business operations demonstrate intent to sell for human use despite FDA warnings. These complaints reveal how manufacturers can leverage a company's own advertising, affiliate relationships, and operational details to build leg
United States Healthcare
BI
Buchanan Ingersoll & Rooney PC
Article
FDA Submits Interim Peptide Compounding Policy For White House Review: What Pharmacies Should Know
FDA has submitted an interim access policy for peptide compounding to the Office of Management and Budget for review, marking a potential shift in federal enforcement. While the submission signals regulatory progress, the policy's scope, covered substances, and operational requirements remain undisclosed, leaving compounding pharmacies to navigate uncertainty about which peptides will qualify and under what conditions they may be prepared.
United States Healthcare
BI
Buchanan Ingersoll & Rooney PC
Article
The House Energy And Commerce Committee’s Fraud Report And The Direction Of Health Care Enforcement
A House Committee staff report proposes shifting federal health care programs from a "pay and chase" to a "detect and prevent" fraud model, identifying high-risk service lines and recommending expanded enforcement authority for CMS. The report examines case examples involving pharmacies, telemedicine platforms, and multi-state schemes, while acknowledging that improper payments encompass a spectrum from documentation errors to deliberate billing fraud.
United States Healthcare
BI
Buchanan Ingersoll & Rooney PC
Article
DOJ’s Fraud Division And HHS-OIG Streamline Self-Disclosure Of Criminal Healthcare Fraud
The U.S. Department of Justice and HHS Office of Inspector General have issued a joint policy streamlining the self-disclosure process for healthcare companies facing potential criminal conduct. Healthcare entities now have a single point of entry through DOJ's National Fraud Enforcement Division, automatically receiving benefits from both agencies' programs while avoiding the confusion of dual submissions.
United States Healthcare
BT
Barnes & Thornburg LLP
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Healthcare

Article
DOJ Fraud Division And HHS-OIG Announce Policy To Coordinate On Voluntary Self-Disclosures In Healthcare Fraud Matters
The Department of Justice's National Fraud Enforcement Division and HHS Office of Inspector General have announced a coordinated policy that streamlines voluntary self-disclosures of healthcare fraud. Companies can now disclose potential criminal conduct to a single point of contact and receive benefits under both DOJ's Corporate Enforcement Policy and HHS-OIG's Self-Disclosure Protocol, eliminating the need for multiple simultaneous disclosures.
United States Criminal
GP
Goodwin Procter LLP
Article
FDA Submits Interim Peptide Compounding Policy For White House Review: What Pharmacies Should Know
FDA has submitted an interim access policy for peptide compounding to the Office of Management and Budget for review, marking a potential shift in federal enforcement. While the submission signals regulatory progress, the policy's scope, covered substances, and operational requirements remain undisclosed, leaving compounding pharmacies to navigate uncertainty about which peptides will qualify and under what conditions they may be prepared.
United States Healthcare
BI
Buchanan Ingersoll & Rooney PC
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Food and Drugs Law

Article
Eli Lilly’s Retatrutide Lawsuits: What Pharmacies, Telemedicine Companies And Online Retailers Need To Know
Eli Lilly has filed five lawsuits targeting companies selling products containing retatrutide, an unapproved investigational peptide. The cases challenge online retailers using "research use only" disclaimers, weight loss clinics, and med spas, alleging their marketing practices and business operations demonstrate intent to sell for human use despite FDA warnings. These complaints reveal how manufacturers can leverage a company's own advertising, affiliate relationships, and operational details to build leg
United States Healthcare
BI
Buchanan Ingersoll & Rooney PC
Article
FDA Submits Interim Peptide Compounding Policy For White House Review: What Pharmacies Should Know
FDA has submitted an interim access policy for peptide compounding to the Office of Management and Budget for review, marking a potential shift in federal enforcement. While the submission signals regulatory progress, the policy's scope, covered substances, and operational requirements remain undisclosed, leaving compounding pharmacies to navigate uncertainty about which peptides will qualify and under what conditions they may be prepared.
United States Healthcare
BI
Buchanan Ingersoll & Rooney PC
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Life Sciences, Biotechnology & Nanotechnology

Article
Benesch Healthcare Dialysis & Nephrology Digest No. 79
Benesch Healthcare Partner Jason Greis recently joined the BackTable Vascular & Interventional Podcast to discuss the growing scrutiny surrounding Medicare audits and what physicians and medical practices should know. During the conversation, he examined common audit triggers, the increasing use of artificial intelligence in audit activities, compliance and documentation best practices, and strategies for responding to audits and navigating the appeals process.
United States Healthcare
B
Benesch Friedlander Coplan & Aronoff LLP
Article
Fresenius Acquires Remaining 45% Stake In MAbxience For Up To €750 Million
Fresenius SE & Co. KGaA has completed its acquisition of the remaining 45% stake in mAbxience Holding S.L., a biosimilar manufacturer, for up to €750 million. The transaction makes mAbxience a wholly owned subsidiary within Fresenius Kabi's Biopharma business, providing the company with greater control over its biosimilar value chain from development through commercialization.
United States Healthcare
GP
Goodwin Procter LLP
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