Last week, Senator Rick Scott introduced the Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act (the “CLEAR LABELS Act” or “Act”). If passed and enacted, the Act would require all prescription medications dispensed in the United States to include clear labeling that identifies the country, or countries, of origin of both the finished drug product and its individual active pharmaceutical ingredients (“APIs”). This a major advance—and likely burden—compared to the current regulatory requirements. In a press release, Senator Scott emphasizes that the intent behind this proposed bill is to provide pharmacists, patients, and regulators with more insight into where prescriptions drugs and their APIs originate.Continue Reading The CLEAR LABELS Act Proposes Changes to the U.S. Prescription Drug Supply Chain

Debated is the genesis of the first direct-to-consumer (DTC) drug concept in the U.S. Going back to at least 2011, Pfizer’s “unorthodox” Diplomat Specialty Pharmacy partnership aimed to launch Lipitor DTC in the face of generic competition. To be sure, there, the strategy did not—nor could it—resemble the more typical DTC format that Pfizer and just about every other large brand in the space offers today. DTC programs today rely heavily on telehealth, which since the pandemic, has greased the consumer access skids, generating significant DOJ activity[1] and creating reams of work for legal and compliance teams to sort through design and strategy.Continue Reading Of Drugs and DTC Platforms: American Consumerism, TrumpRx, Telehealth, and the Specter of Congressional Intervention

Last week, the U.S. Food and Drug Administration (“FDA”) rung in the new year with a flurry of device-related activity, updating two final guidance documents and withdrawing a guidance published back in 2017. The two final guidance documents released on January 6, 2026 pertain to (1) General Wellness Devices and (2) Clinical Decision Support Software, and supersede previous versions of those guidance documents.[1] Then on January 7, 2026, FDA withdrew its guidance entitled “Software as a Medical Device (SAMD): Clinical Evaluation.”[2]Continue Reading “Deregulation” on the Menu: Big Changes for Wellness and CDS Technologies

Just in time for the holidays, on December 15, 2025, the U.S. Food and Drug Administration (“FDA”) Office of Prescription Drug Promotion (“OPDP”) issued an untitled letter (the “Letter”) to Karuna Therapeutics, Inc., a Bristol Myers Squibb Company, concerning a direct-to-consumer broadcast ad for Cobenfy™ (xanomeline and trospium chloride), a drug approved for the treatment of schizophrenia.[1] As we have previously covered at length,[2] the administration continues to crack down on direct-to-consumer (“DTC”) advertising. Notably, this Letter is the second untitled letter released since the government shutdown, demonstrating that DTC advertising remains a key priority.Continue Reading FDA Continues Crack Down on DTC Advertising: Untitled Letter Highlights Pitfalls in Schizophrenia Drug Promotion

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 themes, such as omission or minimization of risk information, ad presentation and form, and promotion consistent with FDA-required labeling (“CFL”). The letters appeared to have been leftovers from the shutdown, dated from earlier in September when the crackdown was in full swing. This is why we refresh these pages daily.Continue Reading What to Watch: Continued DTC Advertising 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 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 how to bring these products to market, especially where they are intended to address rare diseases and/or small populations – an area where traditional drug development paradigms are strained.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