Just before Thanksgiving, the Food and Drug Administration’s (“FDA’s”) Office of Prescription Drug Promotion (“OPDP”) silently published three untitled letters, furthering this administration’s promise to crack down on direct-to-consumer (“DTC”) prescription drug advertising.[1] The letters (which we’ll call “Letter 1,” “Letter 2,” and “Letter 3”) addressed familiar enforcement…

In mid-November 2025, Congress introduced the Biomanufacturing Excellence Act of 2025 (H.R. 6089) to establish a dedicated national center aimed at strengthening U.S. capacity for biopharmaceutical manufacturing. The bipartisan bill signals a material alignment with the current administration’s onshoring and domestic innovation-fostering policy and presents meaningful scale-up opportunities for drug, device, and human-cell/tissue…

On October 28, 2025, the State of Texas filed a complaint against Johnson & Johnson and Kenvue, Inc. (“Kenvue”)—formerly the consumer health division of Johnson & Johnson, and now in the process of being acquired by Kimberly-Clark—alleging deceptive marketing and fraudulent financial moves related to Tylenol (acetaminophen) (the “Lawsuit”).[1] Texas claims these companies hid…

Since the year began, we have attempted to divine the new administration’s approach to regulating human cell and tissue products (“HCT/Ps”).[1] What we have found is a collection of seemingly contradictory signals, keeping us guessing as to whether we will see an increase or decrease in HCT/P regulation – either by written regulation or…

In late September, the U.S. Food & Drug Administration (“FDA”) issued three draft guidances related to cell and gene therapy (“CGT”) products: (1) Innovative Designs for Clinical Trials of CGT Products in Small Populations (the “Innovative Designs Guidance”), (2) Postapproval Methods to Capture Safety and Efficacy Data for CGT Products (the “Postapproval Methods Guidance”), and…

On September 9, 2025, the U.S. Food and Drug Administration (“FDA”) Office of Prescription Drug Promotion (“OPDP”) issued numerous untitled letters as part of the agency’s wider attack on direct to consumer (“DTC”) advertising of pharmaceuticals. Just days after this wave of 50 untitled letters, FDA released around 80 warning letters, which we covered in…

On September 9, 2025, the U.S. Food and Drug Administration (“FDA”) Office of Prescription Drug Promotion (“OPDP”) issued a torrent of untitled letters, 40 in total, just days after rumblings that FDA would be cracking down on direct to consumer (“DTC”) advertising of pharmaceuticals.[1] This enforcement flurry—which we will digest in a later blog post,…