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On October 14, 2024, California Governor Gavin Newsom signed into effect ABX2-1, which was developed and passed in a special legislative session. The aggressive new law — ostensibly designed to prevent the sort of supply...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
The Servier case: The game isn’t over yet - The European Court of Justice recently issued seven judgments in the landmark "Servier" case, confirming the anticompetitive nature of "pay-for-delay" agreements between...more
As is often the case, France has been a pioneer in implementing a mandatory safety stock, especially for essential drugs. Since 2021, pharma companies must hold at least a 2-month safety stock to meet the needs of patients on...more
On October 2, 2024, the U.S. Food and Drug Administration (FDA) determined the shortage of the tirzepatide injection, a glucagon-like peptide 1 (GLP-1) medication, has been “resolved”. The tirzepatide injection had appeared...more
Industries around the world have been hugely affected by global events over the past several years. Wars, famine and water shortages, political unrest and pandemics have all contributed to persistent supply constraints for...more
The June 2024 issue of Vanity Fair included the provocative headline: “Why Counterfeit Ozempic Is a Global-Growth Industry." Novo Nordisk’s patented drug Ozempic® (semaglutide injection) was first approved by the FDA in 2017...more
This update helps automotive suppliers inform their legal and operational decisions to help address challenges and opportunities. Key Developments - Cox Automotive predicts U.S. new light-vehicle sales in the first half...more
Analysis by Julie Dautermann, Competitive Intelligence Analyst This update helps automotive suppliers inform their legal and operational decisions to help address challenges and opportunities. Key Developments - Foley &...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
This update helps automotive suppliers inform their legal and operational decisions to help address challenges and opportunities. Key Developments - Foley & Lardner partner Ann Marie Uetz offers insight on the dynamics...more
On April 10, 2024, CMS issued its annual Hospital Inpatient Prospective Payment System (IPPS) and Long-Term Care Hospital (LTCH) Prospective Payment System (PPS) Proposed Rule for Fiscal Year (FY) 2025 (the Proposed Rule). In...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
This update helps automotive suppliers inform their legal and operational decisions to help address challenges and opportunities. Key Developments - Foley & Lardner LLP partner Nicholas Ellis is quoted in the Supply...more
Share on Twitter Print Share by Email Share Back to top In recent years, viral videos featuring a surprising topic have racked up millions of views on social media. Not videos of a celebrity doing something outrageous, a...more
This is the sixth in our 2024 Year in Preview series examining important trends in white collar law and investigations in the coming year. We will be posting further installments in the series throughout the next several...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 2022, the United States experienced 18 separate weather and climate disasters costing at least one billion dollars according to NOAA. In 2023, that number rose to 28 separate billion dollar weather events. The frequency...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
Health care was one of the most active issue areas in 2023 and this trend is expected to continue when Congress returns in the New Year for the second session of the 118th Congress. The activity by the health committees of...more
The Centers for Medicare and Medicaid Services (CMS) continues to take steps implementing the Inflation Reduction Act of 2022 (IRA). Newly revised guidance issued on December 14, 2023, makes notable changes and clarifications...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
This update helps automotive suppliers inform their legal and operational decisions to help address challenges and opportunities. Key Developments - Foley & Lardner partner Vanessa Miller and retired partner John...more