This Week at FDA: FDA’s ad crackdown, abandoning adcomms, and more

Welcome to another installment of This Week at FDA, your weekly source for updates—big and small—on FDA, drug, and medical device regulation and what we’re reading from around the web. This week, FDA announced a major effort to crack down on prescription drug advertising, HHS laid out its strategy to address children’s health, and the director of FDA’s drug center said he wants to move away from advisory committee meetings for individual drugs.

On Tuesday Health and Human Services (HHS) Secretary Robert Kennedy Jr. released a Make American Health Again (MAHA) Commission report that outlined the Trump administration's strategy to fight childhood chronic illnesses by addressing poor diet, chemical exposures, lack of physical activities and chronic stress, and overmedicalization. The report contains several initiatives tasked to FDA, including streamlining the use of certain investigational drugs for Phase I clinical trials to get them to patients sooner and making user fee negotiations more transparent and efficient.

The report also called on FDA, HHS, the Federal Trade Commission (FTC), and the Department of Justice to ramp up oversight and enforcement of direct-to-consumer drug advertising. Shortly after the report was published, FDA announced a crackdown against what it called “misleading” prescription drug advertisements and to end a longstanding regulation that allows drug companies to provide a major risk statement in ads and provide adequate provision of the complete label information elsewhere.

Both FDA and HHS statements about the advertising crackdown have focused on the concept of adequate provision, arguing that it enables companies to obscure risk information about their products. FDA said it will issue rulemaking to end the use of adequate provision, though it has not offered specifics on what the rulemaking would entail, and said it has sent more than 100 cease and desist letters to drugmakers concerning deceptive ads.

On Friday, FDA published what appears to be the first of these cease-and-desist letters. In an untitled letter sent to AstraZeneca regarding its direct-to-consumer advertisement for its influenza vaccine Flumist. The untitled letter is the first of its kind to be sent to a drugmaker over advertising or promotional issues from the agency’s Center for Biologics Evaluation and Research (CBER) since 2018. In the letter, the agency said the risk statement in the company's TV commercial was too fast-paced with too many attention-grabbing visuals for viewers to adequately understand the information.

Kaiser Health News reported that George Tidmarsh, director of the Center for Drug Evaluation and Research (CDER), said during two meetings this week that the agency wants to stop using external expertise from advisory committees to evaluate and vote on individual drugs under review by the agency. He said the panels were redundant and posed unnecessary work for drugmakers and the agency, though he left the door open to convening advisory committees for class-wide drug issues.

The Washington Post reported that Trump administration health officials plan to link the deaths of 25 children reported in FDA's Vaccine Adverse Event Reporting System (VAERS) to COVID-19 vaccines. While CDC notes that the VAERS system is unverified and isn't designed to assess such conclusions, the findings will reportedly be presented to its Advisory Committee on Immunization Practices (ACIP) next week.

The Wall Street Journal reported that top health officials are also compiling a list of instances when the COVID-19 vaccines caused harmful outcomes in pregnant women. More specifically, FDA is seeking to waive privacy protections to disclose information from those instances publicly.

Last week, several news outlets reported that HHS was set to make a statement that it had discovered a link between autism and the use of Tylenol (acetaminophen) in pregnant women. However, such an announcement has so far not come to fruition. This week, the Wall Street Journal reported that Kirk Perry, interim CEO of Tylenol maker Kenvue, met with Kennedy privately and argued that there was no clear link between the drug and autism.

Health experts at Johns Hopkins University wrote in JAMA that FDA's guidances regarding its accelerated approval pathways are too broad and present challenges for sponsors. The authors provide recommendations on clarifying the agency's expectations for confirmatory trials and safety monitoring in the guidances.

FDA published several draft and final guidances this week, including a final guidance adopting the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use's (ICH) guidelines on E6(R3) good clinical practice (GCP). The agency said it is intended to outline flexible and modern good clinical practices for conducting clinical trials.

FDA also reopened the comment period for its draft guidance adopting ICH M13B bioequivalence for immediate-release solid oral dosage forms guidelines. The comment period opened on 2 June and will stay open until 9 October.

Drugs & Biologics

The Center for Biologics Evaluation and Research's (CBER) Office of Therapeutic Products (OTP) will host a virtual town hall on 22 October to discuss chemistry, manufacturing, and controls (CMC) issues and facility readiness for biological license application (BLA) submissions and post-licensure changes for gene therapy manufacturing facilities. Experts from CBER’s Office of Compliance and Biologics Quality’s Division of Manufacturing and Product Quality (DMPQ) will be at the meeting to answer questions.

FDA announced it has approved AstraZeneca's Koslugo (selumetinib) to treat patients as young as one year old with the genetic disorder neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN). The drug was previously approved for the same cohort of two-year-old and older patients.

Travere Therapeutics announced that FDA is no longer requiring feedback from an advisory committee for its supplemental new drug application (sNDA) for Filspari(sparsentan) to treat focal segmental glomerulosclerosis (FSGS), a major cause of kidney failure. The company stated that the agency's Prescription Drug User Fee Act (PDUFA) target date is 13 January 2026.

Takeda announced that FDA had approved the supplemental biologics license application (sBLA) for Vovendi[von Willebrand factor (Recombinant)]. The drug is manufactured by its subsidiary Baxalta, and the approval expands its indication to include routine prophylaxis to reduce the frequency of bleeding episodes in adult patients with von Willebrand Disease (VWD), including those with Type 1 and 2 disease, and on-demand and perioperative management of bleeding in pediatric patients with VWD.

Johnson & Johnson announced today that FDA has approved its bladder cancer drug Inlexzo (gemcitabine intravesical system). The drug was previously referred to as TAR-200 and is indicated to treat adults with Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors.

Medtech

Earlier this week, Apple announced its Apple Watch Series 11 set to launch next week will include "the most comprehensive set of health features," including hypertension notifications. Following the announcement, Bloomberg reported that Apple had received clearance for its hypertension notification feature.

FDA's Digital Health Advisory Committee is set to meet on 6 November to discuss generative artificial intelligence (Gen-AI) used in digital mental health medical devices. While such devices can help address the growing need for mental health treatment, the committee will also discuss their potential risks.

This Week at FDA: FDA’s ad crackdown, abandoning adcomms, and more

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