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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

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 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 or approved premarket application (“PMA”). Continue Reading What to Watch: WHOOP Warning Letter

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] – have been vocal about the need to lower barriers to market entry for stem cell manufacturers.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 utilize the regulatory carve-out for RUO diagnostic devices.[3] However, after the issuance of that Agena Warning Letter last April, all had been quiet on the enforcement front in the RUO space and, given the priorities of the new administration, we expected it to remain that way. But surprisingly, last month, FDA posted yet another warning letter to DRG Instruments GmbH (“DRG”) alleging failure to qualify for the RUO carve-out (the “Warning Letter”), potentially signaling the Agency’s intention to increase, or at least maintain, oversight for RUO-labeled products.[4]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 believe this to be yet another example of FDA’s enhanced focus on drug advertising and promotion. Expect to see more warning letters—especially via social media advertising and promotion, actions directed at executives or personal social media accounts, and other creative ways the agency can push its mandate—in lieu of written regulation—to police the pharmaceutical industry.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