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
For the past several years, physicians and compounding pharmacies have stepped in to address critical patient access gaps during U.S. Food and Drug Administration (FDA) shortage declarations for semaglutide (Ozempic, Wegovy)...more
On May 7, 2025, the US District Court for the Northern District of Texas upheld the US Food and Drug Administration’s (FDA’s) decision to remove two tirzepatide injection medications from the FDA’s drug shortage list. This...more
The Food and Drug Administration (“FDA”) has removed semaglutide from its drug shortage list after the agency determined the current supply of the drug can meet present and future demand. On February 21, 2025, the FDA updated...more
Glucagon-like peptide-1 agonists, a class of medications known as GLP-1s, have grown in popularity, initially for the treatment of type 2 diabetes and more recently for obesity and other labeled and off-label indications for...more
Weight loss clinics, telehealth companies, physicians, and pharmacies that have been prescribing or dispensing compounded GLP-1 medications must prepare for significant changes following the Food and Drug Administration’s...more
On February 21, the FDA announced that the shortage of semaglutide injection products has been resolved. Semaglutide has appeared on the FDA’s Drug Shortage List since 2022 because demand for the drug exceeded the available...more
On December 19, 2024, FDA formally announced the end of the tirzepatide shortage in a Declaratory Order issued to Eli Lilly & Co. (“Lilly”). Lilly is tirzepatide’s patentholder and the manufacturer of the two branded versions...more
I recently learned of Eli Lilly & Co.’s (“Lilly”) recent lawsuit against FDA from Nicole DeFeudis, who interviewed me for her Endpoints News story about the case. Lilly’s lawsuit, filed in September 2024 in the Southern...more
On December 19, 2024, the U.S. Food and Drug Administration (FDA) issued a declaratory order determining that the shortage of diabetes and weight-loss tirzepatide injection products (Mounjaro and Zepbound; Eli Lilly and...more
Ozempic's meteoric rise has reshaped the landscape of healthcare, retail, and consumer behavior. Its initial popularity as a weight loss medication has sparked a broader conversation around health, wellness, and body image....more
On December 19, 2024, the U.S. Food and Drug Administration (FDA) issued a Declaratory Order reevaluating and re-confirming that the tirzepatide drug shortage has been resolved. This order revoked and replaced FDA’s October...more
On November 20, 2024, Health Canada posted Drug shortages in Canada: Fiscal year 2023 to 2024 in review. The review includes an overview of drug shortages, how Health Canada addresses shortages and the number of drug...more
On October 3, 2024, the US Food and Drug Administration (FDA) revised its shortage categorization of tirzepatide, a glucagon-like peptide 1 (GLP-1) medication, marking the shortage as “resolved” for all presentations of the...more
In an effort to enhance collaboration, the Indian Pharmaceutical Alliance (IPA) recently proposed that a more formal preferred partnership between the U.S. and India can not only lower drug prices in the U.S. but can improve...more
In the wake of persistent drug shortages that compromise patient care and safety, the Biden administration and Congress have proposed policies to strengthen the pharmaceutical supply chain. Using authorities under both...more
A few weeks ago, Regs & Eggs focused on nine health-related issues that were not included in the Fiscal Year (FY) 2025 President’s Budget. Another policy absent from the budget was the Administration’s plan to address drug...more
The Federal Trade Commission (FTC) and the Department of Health and Human Services (HHS) are soliciting public comments on the root causes of and potential solutions to drug shortages. The request for information (RFI)...more
In a recent opinion piece in Newsweek, Dr. Rahul Tiwari asserts that pharmaceutical companies in India have an opportunity to supplant China's dominant position in producing active pharmaceutical ingredients ("API's") and...more
I'm not saying that anyone from the Biden administration was reading my blog post last week on drug shortages, and maybe it's just a coincidence that the White House announced new efforts to strengthen supply chains less than...more
5 When our children were young, we started a tradition at Thanksgiving of going around the table and having each of us (around 20 with extended family) saying what we were thankful for. Of course, you hear a lot of being...more
Health care has been one of the most active issue areas in the 118th Congress. The activity by the health committees of jurisdiction in both the House and the Senate has been fueled in part by efforts to reauthorize various...more
As drug shortages are once again front-page crises news, demanding drastic action by FDA—currently with a particular focus on sterile, injectable platinum-based chemotherapy drugs—a refresher on the scope of FDA’s tools to...more
The Royal Decree of 19 January 2023 (the Royal Decree) concerning the shortage of medicines (i) details the conditions under which a prior authorisation is required to export medicines aimed for the Belgian market to other EU...more
As we have previously reported, in response to the COVID-19 pandemic, the Minister of Health had made interim orders pursuant to the Food and Drugs Act to address the significant risk to health posed by shortages in 2020 and...more
On September 1, 2021, Regulations Amending Certain Regulations Concerning Drugs and Medical Devices (Shortages) (the “Regulations”) were published in Part II of the Canada Gazette. These amendments are intended to provide...more