Dozens of pharma direct-to-consumer (D2C) TV ads are under fire as the FDA demands at least 40 commercials be pulled off the air or changed. A spate of untitled warning letters posted on the FDA’s website charge that the TV ads—from Big Pharma companies including AbbVie, AstraZeneca, Novartis, and Pfizer—are false or misleading. It directs marketers to respond within 15 days with plans for corrective action or defend why the ads do not violate guidelines. This is just the first wave of targeted FDA enforcement on high visibility pharma broadcast TV ads. Marketers and ad agencies need to immediately review commercials for potential problems under the new stricter compliance, and proactively retool them. Analyze the FDA letters to figure out what is now acceptable, and dedicate resources, including new generative AI tools, to create and review ads. Create flexible, modular TV ads that can be changed or reworked quickly if needed.

President Trump signed a memorandum on Tuesday that instructs HHS Secretary Robert F. Kennedy Jr. and the FDA to crack down on direct-to-consumer drug advertising on TV and online channels like social media. While concerning, it’s premature to claim that this is the end of D2C drug advertising. Pharma marketers may find that longer commercials with complete product disclosures are a better fit for digital channels, such as social media and CTV, where consumers are already spending more time. Big Pharma brands also have the budgets to buy lengthier TV spots if they choose. Or companies could work out deals with TV networks in which purchasing ad space becomes cheaper since both sides would be financially motivated to keep running drug commercials during highly-rated programming.

The news: President Trump fired the head of the CDC less than a month after she was approved by the Senate. At least four other senior leaders at the agency also resigned. Director Susan Monarez accused HHS and Secretary Robert F. Kennedy Jr. of “weaponizing public health for political gain and putting millions of American lives at risk” per a statement from her lawyers. Our take: Healthcare brands and pharma marketers need to take the lead and create science-based messaging about vaccines to counter misinformation. They can partner with influencer physicians on social media (where misinformation abounds) with engaging edutainment, and lean into local efforts with community partners like sponsored health screenings or free vaccine days.

Eli Lilly plans to file for global regulatory approval of its first weight loss pill following positive results in a second key trial. People with both obesity and type 2 diabetes lost an average 10.5% of their weight and significantly improved blood sugar levels. Oral GLP-1s faced investor disappointment over weight loss results that fall short of the injectables. However, with around 100 million US adults with obesity, the next gen pills are an opportunity for marketers to rethink how the more convenient, no-needle oral options can fit patients’ needs.

The news: Johnson & Johnson is expanding its US manufacturing presence with a $2 billion investment in North Carolina via a partnership with Fujifilm Biotechnologies. Our take: Some US builds have been in the works for years, which means pharma is happy to make this good-faith “concession”—especially after seeing the impact the COVID-19 pandemic had on global supply chains. Even if Trump changes course on tariffs, or if the next administration has a completely different view, pharma companies won’t regret having more production capability in their biggest market.

More than a dozen food manufacturers have pledged to remove artificial dyes from their products in response to pressure from US Health Secretary Robert F. Kennedy Jr. and the Make America Healthy Again (MAHA) movement. The shift from artificial dyes underscores the increased sway of public health advocates and consumer demand for cleaner labels—even in the absence of conclusive science. It puts food manufacturers in a tough spot: They are under pressure to reformulate without compromising appearance or taste, all while facing steep costs and limited upside for benefits that may be more symbolic than nutritional.

The situation: The compounded GLP-1 market isn’t dying down as quickly as previously expected. Our take: Online healthcare companies are getting crafty with how they market and sell compounded GLP-1s. Novo and Lilly will keep experimenting with legal tactics to get copycat GLP-1s off the market, but their path to victory in court is unclear. Short of the FDA stepping in—and it doesn’t seem like it will—the battle of pharma vs. compounded weight loss drug sellers will get even messier.

The news: Prescription drugmakers can now apply for new Trump administration priority review vouchers that will cut drug approval times down from 10-12 months to just 1-2 months. Our take: Good faith commitments for US drug onshoring investments could translate to valuable advantages if those drugmakers can leverage those into a CNPV. But with so many pharma companies already in that pool, we expect this year’s winners to be drugmakers who can show real evidence of two, three or even all five priorities on the Trump administration list.

The news: An FDA panel endorsed the removal of black box warnings on hormone therapies used for menopause. For context: Black box warnings are the strongest safety warning issued by the FDA for Rx drugs and highlight serious or life-threatening risks. Our take: Removing the black box warning could encourage pharma brands to not only develop more treatments but also market hormone therapy more. While personal risks and benefits still need to be weighed with a doctor, the change may result in more women on treatment.

The news: Pharma companies can earn a speedier path to approvals for new drugs if they agree to lower US prices to global levels. The takeaway: Pharma companies are on board with faster drug approvals and higher global prices, but they still make the bulk of their profits on US sales. By adopting good faith balanced stances—advocating for fairer pricing, but highlighting innovation—pharma can notch wins with the administration and consumers.

The news: Several leading medical associations representing hundreds of thousands of US clinicians, as well as scientists, researchers, and public health workers, have sued HHS Secretary Robert F. Kennedy Jr. and other top health officials over the government’s recent decision to make COVID-19 vaccines more restrictive. The big takeaway: Kennedy is running out of allies in the medical and pharma communities. If nothing else, the lawsuit could force Kennedy and his team to adhere to the legal framework in place for making sudden changes that disrupt the public’s access to vaccines.

The news: Prescription drug approval timelines will shrink under an FDA pilot program that will reduce the approval timelines from a typical 10 months to just 1 to 2 months. Our take: Speedier reviews and new AI programs for drug developers are good ideas, but pharma companies should remember the COVID-19 vaccines speed-to-market backlash and weigh the time benefit against whether their drugs will gain trust with physicians and patients.

The news: Novo Nordisk is partnering with AI drug discovery company Deep Apple Therapeutics to discover and develop new cardiometabolic drugs, including for obesity. The takeaway: Novo is not the biggest loser in the GLP-1 weight loss category, but it’s trailing Lilly in drug effectiveness, market value, and more importantly public perception. It’s critical for Novo to come up with new and better weight loss drugs—hence the deal with Deep Apple—but also polish its brand with consumers. A new CEO and new marketing direction could garner Novo some much-needed cachet.

The news: Avidity Biosciences struck a deal with the FDA for accelerated approval of a treatment for a rare type of muscular dystrophy. Our take: The Avidity announcement and federal health agency enthusiasm are positive signs for biotech and pharma companies looking for accelerated approval for rare disease candidates. Federal authorities and drugmakers will need to balance speed-to-market with rigorous science to ensure physician and consumer confidence.

FDA’s approval process for new COVID-19 vaccines will soon get tougher: But the impact to leading vaccine makers like Pfizer and Moderna might be minimal. Here’s why.

Drug developers relocate clinical trials amid Trump’s NIH research and funding cuts: The final damage to research pipelines is still to be determined, but biotech and pharma companies are already reacting, and more may consider doing so given the uncertainty.

The FDA pushes aggressive timeline to implement AI-assisted drug reviews: The FDA plans to speed up drug reviews with AI by the end of June, but pharma companies already concerned about the impact of layoffs and recent drug approval delays shouldn’t see it as a silver bullet.

RFK to lead Trump’s Make America Healthy Again commission: Trump’s executive order outlines policies and actions that could impact medication access for children, how quickly drugs get to market, and how federal health agencies conduct research.

Trump’s healthcare picks will look to rein in GLP-1 spending: His selections to run the FDA and HHS aren’t big proponents of widespread GLP-1 use for weight loss. We explore what it could mean for the obesity drug market amid a new administration.

FDA says Merz Pharma’s Instagram ad is misleading: The regulator could be ramping up its oversight of drug ads on social media that involve influencers.