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 product sponsors that are part of institutions or public-private partnerships.
Continue Reading Congress Joins the Biomanufacturing Onshoring Party

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 the drug’s risks to unborn and young children—especially links to autism and Attention-Deficit/Hyperactivity Disorder (“ADHD”)—while promoting Tylenol as safe.
Continue Reading Texas Sues Johnson & Johnson and Kenvue Over Tylenol: Scientific Evidence, Regulatory Shifts, and the Future of OTC Drug Labeling

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 enforcement. To date, aside from some recent enforcement,[2] not a whole lot has changed.
Continue Reading What to Watch: Human Cell and Tissue Product Regulation

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 (3) Expedited Programs for Regenerative Medicine Therapies for Serious Conditions (the “Expedited Programs Guidance”) (each, a “Guidance”). Although none of these Guidances appear to significantly alter the existing landscape for CGT products, they do reflect a willingness on behalf of FDA to get creative about…
Continue Reading FDA Touts Continued Commitment to Cell and Gene Therapy Products through Trio of Guidances

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 a separate post.[1]…
Continue Reading FDA’s Wave of Untitled Letters Signals Stricter Scrutiny for DTC Pharma Ads

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, given its complexity—did not stop there as just a week later, on September 16, 2025, FDA released about 80 warning letters. We have forecasted this for months, and now, we believe this wave of action to be the tip of the enforcement iceberg.[2]…
Continue Reading FDA Unleashes Wave of Enforcement: The Industry Faces a Crackdown on Drug Advertising

Late yesterday, FDA issued a press release warning that it would be sending “thousands of letters warning pharmaceutical companies to remove misleading ads and issue approximately 100 cease-and-desist letters to companies with deceptive ads[,]” as well as initiating rulemaking to “close the ‘adequate provision’ loophole[.]” Concurrently, the White House issued its own memorandum, commanding the Secretary of Health and Human Services to take actions “to the extent permitted by applicable law.”…
Continue Reading FDA’s Vast Ad/Promo Warning – Enforcement Ramp-Up or PR Nothingburger?

On July 14, the U.S. Food and Drug Administration (“FDA” or the “Agency”) issued a warning letter (the “Warning Letter”) to WHOOP, Inc. (“WHOOP”), rejecting WHOOP’s claim that its wearable “Blood Pressure Insights” product qualifies as an unregulated wellness product[1] and alleging, instead, that the product qualifies as a “device”[2] under the Food, Drug, and Cosmetics Act (“FDCA”) (i.e., is intended for use in the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition).[3] FDA concludes, therefore, that the product is misbranded and adulterated, as WHOOP is currently marketing the product with a cleared 510(k) notification…
Continue Reading What to Watch: WHOOP Warning Letter

ICYMI over the holiday week (present company included), the U.S. Department of Justice (DOJ) announced a re-energized partnership with the U.S. Department of Health and Human Services (HHS) to enforce the False Claims Act (FCA) through a variety of priority enforcement areas. Especially pertinent to the life sciences industry are drug, device, and biologics pricing (e.g., discounts, rebates, formulary/service fees, and related activities), kickbacks related to drugs and device, and electronic health record manipulation. While the industry is familiar with FCA enforcement in these areas, this announcement further validates our prediction for the administration’s increased and creative enforcement priorities out…
Continue Reading DOJ False Claims “Working Group” Update

Since the publication of our article on what to expect for stem cell regulation under the new administration, we’ve been closely monitoring the administration’s enhanced focus on the same. As discussed in greater length in that article, key players in the new administration, such as Health and Human Services (“HHS”) Secretary, Robert F. Kennedy, Jr. (“Secretary Kennedy”) – who spoke publicly about this initiative even before his appointment and, soon after he was appointed, assembled a roundtable of government and industry personnel to discuss ways to reduce the regulatory burden for stem cell therapies soon after he took office[1]…
Continue Reading What’s Going on with Human Cell and Tissue Products?

Last spring, we wrote about a warning letter the United States Food & Drug Administration (“FDA” or the “Agency”) issued to Agena Bioscience Inc. (the “Agena Warning Letter”)[1] for allegedly promoting its diagnostic product (which was labeled for research use only “RUO” and therefore, not cleared or approved by FDA) for clinical purposes in violation of the U.S. Food, Drug, and Cosmetics Act (the “FDCA”).[2] The Agena Warning Letter – the first issued to an RUO product manufacturer in over five years – left the industry wondering whether FDA intended to ramp up enforcement against manufacturers who improperly…
Continue Reading What to Watch: Potential Increase in Enforcement of “RUO” Diagnostics

This week, the U.S. Food and Drug Administration (“FDA”) Office of Prescription Drug Promotion (“OPDP”) posted a warning letter (the “Letter”)[1], issued on May 29, 2025, to Sprout Pharmaceuticals, Inc. (“Sprout”) and its CEO, Cindy Eckert (“Eckert”), regarding a social media post promoting ADDYI® (flibanserin) (“Addyi”). According to FDA, the now-flagged Instagram post, shared by Eckert, touted Addyi’s benefits but left out crucial safety information and important details on for the indicated population. There is a lot to unpack with this Letter and FDA’s manner of issuance, but as previewed in our prior blog posts this year, we…
Continue Reading FDA Ratchets Enforcement on Social Media Promotion in New Warning Letter

In an interesting and somewhat unexpected turnabout over the last six months, FDA has pivoted its focus from regulating industry’s use of artificial intelligence (“AI”) to how the agency itself utilizes AI. This internal shift marks a departure from FDA’s development of AI guidance over the last few years.
Continue Reading What to Watch: FDA Shifts Attention on Artificial Intelligence