Over the last November weekend of 2025, a memo circulated throughout the Federal Food and Drug Administration that might well trigger the entire unraveling of the US vaccine program with a focus on the mandated COVID shot in particular. The author is Dr. Vinay Prasad, who was a moderate critic during the COVID but has become ferocious since his appointment as the head of the Center for Biologics...
Nitrosamines are by-products of many common chemical reactions. FatCamera/iStock via Getty Images Plus ~~~~~ A generic blood pressure drug called prazosin, made by Teva Pharmaceuticals, is being recalled by the Food and Drug Administration because it contains elevated levels of cancer-causing chemicals called nitrosamines. The recall, which Teva announced on Oct. 7, 2025, affects more than...
An effective defense for fraud allegations begins with proactive compliance controls tailored to healthcare operations. Federal and state authorities increasingly scrutinize billing patterns, documentation and financial relationships under the False Claims Act, 31 U.S.C. § 3729 et seq., the Anti-Kickback Statute, 42 U.S.C. § 1320a-7b, and related regulations. As a healthcare executive, you must...
The behavioral healthcare and addiction treatment industry in Florida is facing a critical challenge. Addiction treatment providers, who deliver essential care to individuals seeking recovery, are now confronted with a development that threatens the sustainability of their services. In August 2025, detox and residential treatment facilities throughout Florida contracted with Ambetter, Centene’s...
FDA’s “Green List” for GLP-1 Ingredients On September 5, 2025, the U.S. Food and Drug Administration (FDA) announced a new “green list” import alert for active pharmaceutical ingredients (APIs) used in GLP-1 medications such as semaglutide and tirzepatide. The green list will include GLP-1 APIs from facilities the agency has inspected or evaluated that appear to be in compliance with the FDA’s...
The most prevalent type of defense investigations in healthcare are those related to Medicare or Medicaid fraud. Agencies such as the Department of Justice (DOJ) and the Department of Health and Human Services Office of Inspector General (HHS-OIG) rigorously investigate billing patterns that suggest excessive claims, duplication of services, or medically unnecessary procedures. Such...
