35 state attorneys general are pushing Meta for tighter enforcement of its advertising policies amid a “surge of misleading marketing for weight loss products” on Facebook and Instagram. The state AGs’ letter will surely get the attention of the FDA, meaning telehealth marketers must ensure they aren’t specifically promoting GLP-1s to people who don’t meet the clinical criteria or using messaging that body shames. Meanwhile, social media companies and advertising platforms need to strictly enforce transparency disclosures on AI-generated ads while closely reviewing all weight loss drug promotions, given the risks of misleading claims and unrealistic expectations.

The FDA sent warning letters to four major retailers that continued to sell baby formula linked to a botulism outbreak after the products were recalled in early November. As retailers move deeper into health and wellness, their daily operations need to support the image they’re trying to build.

Online healthcare companies are increasingly marketing GLP-1 prescriptions to people who aren't overweight or obese, according to a recent Bloomberg story. Federal regulators are starting to crack down on telehealth platforms for their compounded GLP-1 ads. So far, the FDA and FTC have targeted companies claiming their copycat weight loss drugs are the same as brand-name versions and that allegedly mislead consumers with misrepresented products and reviews. These actions could signal that the feds will next go after entities that advertise GLP-1s for unapproved uses, such as for cosmetic purposes for people whose BMI isn’t at least 27.

Marc Cuban Cost Plus Drug online pharmacy founder Mark Cuban wants the Trump administration to waive generic drug regulatory approval fees, the entrepreneur told Reuters. Cuban’s push into US manufacturing could help lower prices for some high-cost generic drugs by adding competition where little currently exists.

Pharma and biotech companies will soon be able to seek drug approvals with just one clinical trial instead of the standard two under upcoming policy changes from FDA chief Marty Makary, per STAT. While some drugmakers may benefit from the shift to a one-study standard by cutting both costs and timelines, vaccine manufacturers are facing pressure to produce more evidence of effectiveness.

The FDA is introducing agentic AI to help its drug reviewers, investigators, and scientists carry out more complex tasks and develop AI-driven workflows. Its move into agentic AI signals that AI-driven review is becoming a regulatory norm.

Two-thirds (65%) of pharma marketers are wary of AI use for creating regulatory filings, according to a new Klick Health and Momentum Events survey. While AI-assisted review is likely to become a standard part of regulatory workflows for both industry submissions and agency evaluations, human oversight will remain important.

The FDA appointed long-time cancer therapy regulator Dr. Richard Pazdur as the new director of the Center for Drug Evaluation and Research (CDER). Pazdur’s appointment is likely to reassure drugmakers that have been concerned about regulatory changes and slower drug reviews and approvals, and signals a return to more predictable science-driven drug evaluation and oversight.

Mark Cuban’s online pharmacy, Cost Plus Drug Company, signed a deal to sell a biosimilar version of Johnson & Johnson’s drug Stelara at a price far below the brand-name list price and lower than competing biosimilars. Starjemza isn’t Cost Plus’ first move into biosimilars, but the drug’s steep discount compared to other Stelara competitors could pose a real challenge to typical pharmacy benefit manager pricing negotiations.

Between 2022 and 2024, Novo Nordisk spent about $7.5 million to have Ozempic ads run on related search keywords to drive users to its prescription drug brand website, according to a JAMA Network Open study. Novo spent the $7.5 million across 15,000 paid keywords related to weight loss, which generated 2.4 million paid visits to Ozempic.com. Some drugmakers might be getting away with pay-per-click drug advertising that promotes their product for off-label use. Given that pharma companies devote about 56% of their annual digital ad spend to search—the second-highest share of any sector—marketers should work with search platforms to better align paid keywords with appropriate drug ad placements.

As healthcare and pharma ad spend shifts to digital, discover the CTV, social, and search trends redefining media strategy in our latest forecast.

Texas Attorney General Ken Paxton is suing Johnson & Johnson and Kenvue, alleging that the companies “deceptively market” Tylenol to pregnant mothers despite knowing the pain medication increases the risk of autism and ADHD in children. The lawsuit comes just a few days after President Trump again warned pregnant mothers not to take Tylenol “unless absolutely necessary” and not to give young children the medication. Kenvue will now need to take action, given the unpredictable nature of when Trump will comment next, along with his administration’s efforts to relabel Tylenol. Efforts should emphasize direct consumer assurance of the drug’s safety, trusted expert validation, and physician-first communication.

The rate of prescription drug approvals decreased while drug review delays and rejections increased in Q3, according to an RBC Capital Markets analysis analysis. Rising rejection rates and delays raise the bar for pharma companies. Drugmakers need to ensure complete, high-quality submissions that anticipate scrutiny and minimize risk. AI tools can play a key role by flagging data gaps, predicting reviewer questions, and optimizing application language to current FDA standards and preferences before submission.

Americans’ trust in federal health agencies and political leaders continues to erode, but while many are confused about what to believe, they still want clearer guidance, per the latest Axios/Ipsos American Health Index. Federal agency staffing cuts, shifting vaccine guidance, and the glut of social media health information have fragmented Americans’ health trust. But trust hasn’t completely disappeared; it’s just gone local. Consumers still believe their doctors and families, creating an opening for healthcare and pharma brands to deliver clear, credible information through those trusted messengers.

EMD Serono, a division of Merck KGaA, reached a drug pricing deal with the Trump administration that will lower the cost of the company’s fertility treatments in exchange for tariff reprieve and expedited regulatory review of a product being brought to the US. Pharma’s pricing agreements with the government suggest they were far more worried about tariffs on US drug imports than they admitted in earnings calls or media interviews. Large drugmakers that are thinking through their own versions of deals will need to weigh their proposed product discounts against tariff exposure if they choose not to comply with the administration.

The FDA sent another batch of warning letters to direct-to-consumer pharma advertisers, adding healthcare professional marketing to its list of complaints. Marketers should prepare for more intense medical and legal review checks, but also expand beyond brand messaging rather than pullback on the key HCP prescriber audience.

A generic version of the abortion pill mifepristone was quietly approved by the FDA before the federal government shutdown. Pharmacies need to provide clear, state-specific guidance so consumers don’t have to guess about access in their area. They can create discreet information channels that ensure consumers’ confidentiality while seeking information, such as secure online consultations with pharmacists or privacy-secure QR code links.

The FDA is considering a change to the labels of Tylenol and other drugs containing acetaminophen. The new label would warn that using these drugs during pregnancy might be linked to a higher risk of autism and ADHD in children. Marketers in this space will want to be transparent in ads and promotional materials that their medicine contains acetaminophen since consumers are far less familiar with ingredients than prescription drug brands. Campaigns should avoid using language overstating the certainty that acetaminophen isn’t linked to autism and re-emphasize that pregnant women should always consult their doctors before taking the medicine.

A new study shows that Eli Lilly's oral weight loss drug is more effective than Novo Nordisk's oral diabetes drug for type 2 patients. Novo also touted its own clinical study for its higher-dose 25-mg pill, currently under FDA review as “Wegovy pill,” which resulted in average 16.6% weight loss among patients. That’s on par with Wegovy’s injectable version. We think the key to success will come down to pricing. Consumers and payers are balking at current $500 to $1,000 per month injectable drug costs. With lower effectiveness rates, and cheaper upfront manufacturing, pills will likely be priced lower—but just how low will determine market success. A low-cost pill, paired with clear value messaging for distinct audience segments, will drive broader adoption and fuel sales growth.

The FDA claims Hims & Hers’ compounded GLP-1 offering is being falsely marketed on its website, and its Super Bowl weight loss drug ad is under scrutiny for omitting side effect and risk information. Telehealth players in the copycat GLP-1 space can easily change marketing language online, and likely don’t have to worry about adhering to drug advertising laws that apply to pharma manufacturers—yet.