Commercialization, marketing and social media

Can drugmakers find a way around the pharmacy benefit manager model often blamed for rising drug costs? Some pharma companies are giving it a shot by reaching out directly to large, self-insured employers.

For years, employers have sought to streamline their relationships with drugmakers to lower costs. But until recently, there was no clear path around PBMs, the intermediaries who distribute, formulate and process claims. 

These middlemen often charge fees that erode the value of manufacturer rebates, said Drew Wilkins, a managing director at Deloitte, focused on commercial life sciences.

But amid growing political pressure to reduce drug costs and intense demand for GLP-1 drugs, pharma giants Novo Nordisk and Eli Lilly are this month testing a new direct-to-employer model that would allow self-insured companies to negotiate weight loss treatment prices directly with manufacturers. 

The two companies are partnering with Waltz Health, a digital health company with a program that enables companies to purchase drugs at a fixed price. Waltz will administer the program, including patient eligibility, screening pharmacy and prescription-related tasks, as well as offering customer service support.

While these programs are currently limited to GLP-1 medications, Wilkins said they could mark the beginning of a broader shift, with more drugmakers adopting similar approaches and expanding drug offerings. 

“We're going to begin to see other manufacturers and large employers push on this and identify where it makes sense to have these models and how we can start to see them emerge,” he said. 

Additional manufacturers could join the market as soon as the end of this year and eventually add more drugs. 

“Early Alzheimer's, other cognitive disorders and diseases like muscle weakening could be interesting candidates for these models, and a way to tap into an eager population trying to think about their overall health and wellbeing in the long run,” Wilkins said. 

Other products may be less suited for the model. 

“I do not expect that you'll see it in things like rare diseases or oncology,” Wilkins said. 

Meeting GLP-1 demand 

GLP-1 drugs marked a natural starting point for a direct-to-employer venture because of the highly competitive space they inhabit and a surplus of consumer demand. A growing body of evidence shows that these drugs confer broader health benefits and potential cost savings over time, which makes them appealing to companies with long-term employees, Wilkins said. 

Employees could share in those savings under the new model. Under the traditional model, the patient typically paid a percentage of the list price, not the lower net cost that includes a manufacturer’s rebate. 

“So, if the drug is $1,000 and you have a 20% co-pay, you're paying off that $1,000 even though the net price is probably closer to $500,” Wilkins said. “If we get rid of rebates and move closer to that net price, your co-pay … should be reduced as well.” 

The model would also give patients broader access to GLP-1 drugs. Currently, only about 19% of companies with 200-plus employees provide GLP-1 coverage.

Direct-to-employer programs will likely be adopted primarily by mid-size and larger companies, but they could open the door to new drug pricing approaches more broadly. True innovation might not occur at the outset, Wilkins said, but a closer relationship between the manufacturer and the employer could drive change.

“They'll be able to think about things like, what about a subscription model? What about other types of risk-based contracts, value-based contracts? The data flow will be cleaner, easier and better able to align the incentives,” he said. 

But the trajectory will largely depend on how this initial foray plays out. 

This model could also spur PBM changes. Some PBMs, feeling the pricing pinch, have already moved to secure new GLP-1 rebates and discounts from manufacturers for group health plans that could lower costs for patients. 

But with the advent of direct-to-employer programs, PBMs could be incentivized to adjust their fees to stay competitive, driving down drug prices overall, Wilkins said. One shift might include basing PBM fees on service delivery rather than drug costs. It might not cost the PBM more to deliver services for a $10,000-a-year product versus a $100,000-a-year product, he said.

Grappling with the unknowns

While this direct-to-employer model ostensibly cuts out traditional PBMs, there’s still technically a middleman involved. In theory, Waltz and other potential intermediaries could come to resemble PBMs over time. But Wilkins said he hopes the model will bring change, even if it takes time to get there.

“I think if it proves itself and demonstrates that it really is a way to lower costs to self insured employers and patients, while also being accretive to manufacturers, it could really trigger a wider paradigm shift in how we structure the access landscape, how we provide drugs, and how drugs are purchased and provided to patients,” Wilkins said.

With TV ads and direct-to-consumer marketing under fire in pharma, the industry needs a new way to reach patients. Cue the influencers. 

“Social media influencers are a big play for pharma in the future,” said Faruk Capan, chief innovation officer at Eversana and CEO of Eversana InTouch.

A parade of celebrities has graced pharma ads in recent years. Pop star Lady Gaga became the face of Pfizer’s campaign to sell Nurtec ODT, while tennis star Serena Williams teamed up with AbbVie to promote a different migraine drug, Ubrelvy.

But the new ideal influencer isn’t just always “famous,” Capan said. Instead, they should be “more altruistic.”

“[Influencers] should have more health-related expertise,” Capan suggested. “[It may be] people who only have a few thousand followers, but are more critical [to the industry].”

Now, influencers with those specific criteria can be generated from AI.

“We built one of the first AI social media influencers in pharma,” Capan said.

Eversana unveiled a new marketing platform in 2025 designed to deliver end-to-end commercialization services through AI agents trained in omnichannel development, market strategy, branding and content creation. Called Agency AI, the platform was created in partnership with technology titan Google Cloud and can whittle a year’s worth of agency work into minutes, the company claims.

It's also part of an emerging push to leverage agentic AI — an ideal fix for burdensome and repetitive tasks across the industry. In the clinical trials space, for example, Medable recently rolled out a platform powered by AI agents that monitor data submission, flag potential errors and communicate directly with sites about needed information.  

And because agentic AI is relatively new for pharma, a bevy of use-cases remains largely untapped. 

After analyzing 270 workflows from 1,200 tasks in the life sciences, McKinsey recently estimated that 75% to 85% of the work could be augmented by AI agents.

If a company implements Agency AI, the workflow shifts will amount to 80% of tasks being generated by AI, with humans in the loop for the remaining 20%.

“We didn’t build this to replace or cut people, but the reality in the market is that clients want efficiency,” Capan said. “AI won’t replace you, but people using AI will.”

But alongside the efficiencies pharma can gain from AI, the technology is also giving rise to potential hurdles.

AI’s thorny new era

AI’s steady creep into marketing has triggered a host of ethical concerns for drugmakers. A social media influencer that’s outed as being fake, for example, could erode public trust in the industry — already a long-standing challenge.

Questions also remain over the legal accountability for AI-generated content if it’s later accused of or found to be being misleading. 

The Federal Trade Commission last year took aim at the issue with rules banning AI-generated consumer reviews and testimonials that “misrepresent the experience of the person giving it.”

The FTC isn’t the only agency becoming more hostile toward marketing practices. Drug regulators are also on the case.

The FDA in September launched a broad “crackdown on deceptive drug advertising” that includes plans to target companies that “conceal critical safety risks.” The agency called out social media for being part of the problem by leveraging “undisclosed paid influencer promotion” and blurring “the lines among editorial content, user-generated media and pharmaceutical advertising.”

While the FDA didn’t mention AI specifically — except to say the agency will be using AI to review drug ads — it promised to “aggressively deploy” all of its “enforcement tools” to ensure drugmakers aren’t misleading the public.

How can pharma stay out of regulators’ crosshairs? Marketing pros generally suggest that companies clearly disclose when content is sponsored and when it’s generated by AI.

The Agency AI platform will also be updated monthly or quarterly to help keep companies in compliance, Capan said.

“The technology is not a problem — it’s about compliance and making sure [companies] know which changes they are going to face,” Capan said.

Data safety, especially for intellectual property, is also a chief concern for pharma when using new platforms. But Capan pointed to Salesforce as an example of a massive platform that’s proven it can keep sensitive information under a digital lock and key, and said the company developed AI Agency with security top of mind.

“You have your own playground on the platform and [data] doesn’t go outside of it and become a bigger issue,” Capan said. “We have a lot of safeguards.”

Sponsored content

By EVERSANA

It feels like a broken record. Across the pharmaceutical and biotech sectors, new therapy launches continue to fail to meet projected sales forecasts. According to one recent industry example,1 66% percent of launches underdelivered—with reasons ranging from clinical and logistical complexities to relentless pricing pressures and rising overhead costs. Despite these perennial frustrations, many brand leaders have been slow to adapt or even adjust. As the adage goes, “Nothing changes if nothing changes.”

The reason why the status quo remains baffles the mind. Over the past five years, the industry has experienced a flurry of innovation in commercialization strategy and options. So, we must ask: How do we get out of our own way?

Using DTP… ASAP… (our industry loves a great acronym)

Enter the boom of GLP-1s in recent years and the rise of “Direct-to-Patient.” The DTP model was developed to help life sciences companies close critical gaps in market reach. DTP promises to identify, directly engage and then compliantly activate previously undiagnosed or treatment-naïve patients. While DTP quickly became an industry buzzword “du jour” in the last 12 months, few leaders truly understood it and veteran leaders of pharma commercialization were hesitant to dive in.

Let’s break it down. Yes, a core component is a telehealth platform and distribution channel, but “If you build it, it doesn’t mean they will come.” A model like DTP cannot deliver its potential unless it’s part of a broader commercial strategy and smart marketing approach to drive patients to the platform is deployed. 

If strategized and executed correctly, DTP will engage and educate individuals who are actively researching symptoms or looking for a new treatment option. AI-informed capabilities then activate messaging with “next best actions” that empower “activated patients” to take decisive action like scheduling a virtual consult and verifying their insurance coverage. Ultimately the goal is to allow patients to receive a timely diagnosis—typically within a day or so—and then allow them to access therapy as quickly as possible.

Early adopters, based on data provided by EVERSANA DIRECT ™ Commercialization, have realized tangible improvement in several key metrics, reporting these improvements:

• Onboarding/conversion rates (whereby prescriptions written by HCPs are dispensed and received by the patient) up to 95%, versus 50% industry average
• Adherence/refill rates of 90% versus 50% industry average
• Patient-acquisition costs that are 30 to 50% lower than previously possible

Of critical importance is that a DTP channel does not cannibalize the brand’s existing HCP-directed patient base or the value of an effective pharma field force. Rather, this novel digital channel helps life sciences brand teams to cost-effectively identify, engage and activate patients. The contracted outsourcing arrangement gives drug developers the opportunity to greatly extend the reach of the medication within its therapeutic space, without requiring significant investment in permanent internal overhead and personnel.

Using DTP to Amplify an Integrated Commercialization Model

When pharma companies or individual brand teams try to “check-to-box" with some tech adoption or create ad hoc DTP offerings by engaging different vendors to provide selected program elements (such as HCP and patient awareness, telehealth, electronic benefits verification, digital pharmacy, support services, and so on), the resulting patchwork approach creates unavoidable siloes that reduce visibility and efficiency of the overall operation. For instance, each service provider must first be identified, vetted, and onboarded. Similarly, each service provider will then have its own P&L methodology and thus, different embedded drivers for profitability. Creating seamless interoperability among competing technology platforms, standard operating procedures (SOPs) and more creates challenges that up until now, have just been accepted as the status quo, or “the way it’s been done for years.”

By contrast, brand teams are most successful when a single commercialization partner can provide all aspects of the commercialization strategy using a unified approach, including a single unified P&L strategy to govern all activities.

Adding a DTP channel within the commercial strategy and working with a single partner to carry out all aspects of the commercialization, including driving patients to the channel as a strategy, helps to align all business objectives and financial incentives, increase visibility, drive efficiency and further reduce overall risk.

Every Barrier Breaks with the Right Incentive

Pairing integrated commercialization with a targeted, marketing-first DTP channel, offers brand teams a seamless outsourcing solution that meets the needs of both HCPs and patients in ways that drive both clinical and commercial success for all stakeholders. The ability to do this while also realizing cost savings and operational efficiencies can help to further differentiate the medication from other options, provide competitive advantage and boost the brand reputation within the therapeutic space.

Download the full article here. 

Hemophilia gene therapies arrived on the market a few years ago with blockbuster expectations. But now, one therapy has been pulled from the market while two are fighting an uphill battle for reimbursement and a solid place in a wobbly market, according to Dr. Michael Recht, chief medical and scientific officer for the National Bleeding Disorders Foundation.

Analysts predicted Biomarin Pharmaceutical’s hemophilia A gene therapy Roctavian would hit peak sales of $2.2 billion. Instead, Biomarin is now looking to offload the drug due to weak commercial uptake. 

In a similar position, Pfizer pulled its hemophilia B treatment Beqvez from the market while CSL Behring’s Hemgenix, which was first to market, is also significantly underperforming in hemophilia B.

Dismal sales came as a surprise to many who saw hemophilia gene therapies as a major scientific leap forward and a promising one-time alternative that could free patients from frequent clotting factor infusions or injections. 

But gene therapies come with a high price tag. Hemgenix became the world’s most expensive drug when it was approved in 2022, with a list price of $3.5 million per dose. Still, treatment could be worth the sticker shock, and CSL estimates that Hemgenix could save up to $5.8 million per person by eliminating the need for once or twice-weekly clotting factor injections.

“It’s a value-laden intervention,” Recht said. “It’s just shockingly expensive.”

Reimbursement hurdles

Payers have balked at the bill for gene therapy treatments, although Recht said all of his interested patients have been able to get them. 

“As part of an advocacy organization, when we’ve spoken to the payers, what we've heard is, ‘Well, the average time someone is on a specific health plan, since the Affordable Care Act has been around, is under two years. So, why should we pay for lifetime therapy when that person might be on our plan for under two years?’” Recht said. 

Still, an NBDF data analysis found that rapid plan hopping is not as common as insurers claim. Since the introduction of the Affordable Care Act, people typically only change plans when they change jobs, he said.

Beyond reimbursement, structural disincentives further complicate adoption. The Hemophilia Treatment Center 340B Factor Program offers certified organizations discounts for medications and supplies. The centers can then reinvest those savings back into facility programs. 

The money for gene therapy, however, typically gets paid to a hospital, Recht said. 

“So the hospital would get all the income from the gene therapy, and the treatment center could lose $500,000 to $750,000 a year in revenues from someone on prophylaxis,” he said. 

This discourages partaking in gene therapy, he said. 

“To me, that is not a compelling reason at all, and potentially an unethical reason if this is the right drug [for a patient],” Recht said. “But this is what I've heard from some of my colleagues.” 

Making the gene therapy leap

While gene therapy isn’t the best option for all patients, it could be for a subset, Recht said. But many can afford to take a wait-and-see approach because other treatments are effective. 

“There are some really great non-gene therapy options for people with hemophilia A,” Recht said. “[Hemlibra] is a great drug, and has changed the way I’ve treated people.”

Many patients also don’t qualify for treatment. Hemgenix targets hemophilia B, which makes up only about 15% of overall cases, and some patients, including children and those with certain liver conditions, are excluded.

For Beqvez, uptake obstacles proved too difficult to overcome. 

“I think Pfizer's [Beqvez] was a perfectly good product,” Recht said. “But as the second to market with the results of their phase 3 maybe not as robust as the Hemgenix clinical trial, I think that played a big role.”

Roctavian, a hemophilia A option, targets a broader pool of patients, but has also faced challenges. 

“The durability is the biggest issue,” Recht said, noting that it’s still uncertain how long the treatment will last, although recent data showed it was still working after five years. “To get 10 years of not having hemophilia, that's still 10 years of not having hemophilia.”

The market’s future

Despite the market struggles, the future for hemophilia patients is promising. 

“I'm very hopeful there will be products to address the unmet needs of the inheritable bleeding disorders population,” Recht said. 

Novo Nordisk, for example, recently submitted an application for Mim8, a drug that Recht predicts could be as safe and effective as Hemlibra, but potentially more appealing to patients because it uses a pen-injector.

Interest in gene therapy hasn’t waned, and companies are still looking for a way in. Be Biopharma is in phase 1 with BE-101, a cell therapy with a twist. 

“They’re putting the vector into a person’s own B cells,” Recht said. “The fascinating part about this is if this is safe and it works, it will be re-dosable because you won’t have an immune response like you do with an adeno-associated virus vector.”

Startups are also testing gene editing for hemophilia, Recht said. However, many of these treatments are years from reaching patients.

While determining the best uses for all the existing medications remains a challenge, there are more options than ever. 

“Where we are today in the 30-ish years of my career … is a miracle,” he said.

When Madrigal Pharmaceuticals secured its history-making approval of Rezdiffra for metabolic dysfunction-associated steatohepatitis — the liver disease MASH — the path to commercial success was littered with snags.

First and foremost, the drugmaker had to blaze a trail for the serious liver disease caused by fat accumulation, which can go symptomless for long periods of time. With no prior drugs on the market, there was also no established care pathway. 

Despite the challenges, Madrigal’s rollout has consistently beat expectations, including in the third quarter of 2025 with more than $287 million in net sales. On pace to exceed $1 billion for the full year, Rezdiffra is the de facto MASH leader. But the monopoly was short-lived.

Novo Nordisk’s weight loss blockbuster Wegovy earned FDA approval for MASH in August, causing Madrigal shares to temporarily dip and raising questions regarding Rezdiffra’s future as a MASH standout.

Rivals incoming

Madrigal hopes it can maintain a healthy lead in the face of new competition that’s set to grow as several late-stage drugs near approval. Notable contenders include three fibroblast growth factor 21 drugs that have spurred deals with Big Pharma. 

The phase 3 drug candidate pegozafermin, developed by 89Bio, was the subject of a Roche deal, and late-stage efruxiermin from Akero Therapeutics was a Novo Nordisk target. GSK also entered the fray to acquire efimosfermin as part of a larger deal for Boston Pharmaceuticals. 

Using a different modality, Boehringer Ingelheim is advancing the dual glucagon/GLP-1 receptor agonist survodutide licensed from Zealand Pharmaceuticals. 

Can Rezdiffra stand up to the stiff competition?

Madrigal built its Rezdiffra foundation on a narrow, clearly defined patient population of about 315,000 people diagnosed with MASH who have moderate to advanced liver fibrosis and are already under the care of a liver specialist. 

The drugmaker’s small marketing team maintains a patient-centered focus, said Adama Sall, vice president, head of patient experience and access at Madrigal. The aim is to help doctors match the drug to the right patient — and overcome barriers like cost and awareness to keep them coming back. Currently, Rezdiffra has more than 10,000 prescribers. 

Sall said company leaders remain confident in the drug despite the expanding competitive landscape, and perhaps even bolstered by it. 

“It’s an unusual stance, but we are very welcoming of other drugs coming to the market because it will increase the awareness of MASH,” Sall said. “I think they’re going to help diagnose more patients.” 

Navigating a changing market 

Madrigal depends on cross-functional collaboration and AI-driven responsiveness to data to keep the momentum going, Sall said. 

“Because we’re a small company, we’re able to act on insights very rapidly,” she said, noting that while the core approach has remained the same, new information has prompted technical pivots. 

But key to the strategy are relationships the company has made with prescribers and patients, as well as strong partnerships with advocacy groups, she said. 

“We invest a lot in trying to think about the pain points that hepatologist and gastroenterologist offices are facing … and the pain points that our patients are facing that go beyond the drug,” Sall said. “How can we address that, and how can we help them in a compliant way?” 

A Madrigal patient support team targets cost challenges, which are a major reason many Americans either abandon or don’t even begin treatment. Patients sometimes hear the drug’s $47,400 annual price tag and assume it’s out of reach. 

“They don’t realize that there are so many solutions that actually make the drug affordable,” Sall said.

Holistic patient support

Because people taking Rezdiffra also need to make lifestyle changes such as diet and exercise, Madrigal provides additional support including tailored nutrition education. The company plans to roll out a digital patient companion app to track medication, activity and nutrition. 

The team is now planning on helping people move beyond primary care to find MASH specialists through website resources and awareness campaigns. They’re also intent on solving other challenges physicians face: learning how to stage the disease and gaining access to necessary equipment. 

“There's a high need for education in the community, even in [gastrointestinal] offices,” Sall said. Another goal is to expand the Rezdiffra provider base, and Madrigal is also investing in endocrinologist education in MASH, she said.

“[MASH] can be a very scary diagnosis,” Sall said. “We want to continue investment … to better support our patients to stay on therapy.”

For 33 years, the biopharma Geron fought tooth and nail to develop the first-in-class telomerase inhibitor blood cancer treatment Rytelo. When it finally won FDA approval in 2024 to treat anemia in patients with lower-risk myelodysplastic syndromes, folks at the company were overjoyed. In fact, the news “brought tears to my eyes,” Dr. Faye Feller, Geron’s executive vice president and chief medical officer at the time, told PharmaVoice.

But Geron soon learned that launching a promising treatment isn’t enough to guarantee success, even if it’s built on Nobel Prize-winning science.

“When we launched our asset, the expectation of the market was one thing, and then our initial performance was not in line with the market expectation,” said Harout Semerjian, who took over as Geron’s president and CEO in August.

Geron’s most recent financial results showed that Rytelo missed its revenue targets in the third quarter, just months after the company called first-quarter demand for the drug “relatively flat.”

Geron also learned that becoming a commercial-stage company after decades working in the clinic isn’t easy.

“One day you wake up, you get an approval, and then you slap [on] a field force and call yourself a commercial company,” Semerjian said. “It doesn't work that way. You really have to be very methodical in the transformation.”

Now, Semerjian has taken the helm to help Geron find its feet as a commercial-stage company, drawing on decades in the pharma industry, including a stint at Novartis, where he was global lead for Gleevec and Kisqali, as well as head of the U.S. hematology franchise.

“That's my forte, having launched 20-plus therapies in hematology and oncology,” he said. “We have a very good drug that we can get to patients. We are at a pivotal time where I can make a difference with my background, and we have a team that’s really hungry to do that.”

The company has “the resources to actually get it done from a financial perspective,” with approximately $421 million in cash, cash equivalents, restricted cash and marketable securities as of Sept. 30, he said.

Here, Semerjian talks about his first months leading Geron and his plans to boost Rytelo’s sales through increased awareness and education.

This interview has been edited for brevity and style.

PHARMAVOICE: What has been your focus since landing in the CEO role in August?

HAROUT SEMERJIAN: One of the key things I've been doing is understanding how Rytelo is being perceived internally, but also even more importantly, by our external stakeholders — the physicians themselves who are the prescribers, the payers and the patients.

One thing which was very clear to me from the first week is the need to educate the community on the power of Rytelo, the appropriate patients [and] how to appropriately use it to ensure the maximum benefit.

It's about maximizing the potential of Rytelo in the U.S. through a significant surge in education and connectivity and being present in the right hematology forums.

[We’re] making sure we're set up as a company to be around the table on a commercial time clock, not a clinical time clock. There's a big difference … clinical time clocks are measured in years and the commercial time clock is measured in seconds and minutes because you're in front of patients that you can help today.

As you look back on your career and the drugs you’ve launched, are there particular lessons you’re applying to Rytelo?  

Absolutely. I think my background really helps me not only with best practices, but also things that might not have gone as we intended. I learned more from the ones that went sideways more than the others.

I was the global lead for Gleevec … probably the poster child of a drug that is unbelievable. It transformed patients' lives in chronic myelogenous leukemia [and] was on the cover of Time Magazine as the magic pill. If there’s any drug that should sell itself, that’s Gleevec.

And even there, we had to educate. We had to make sure we engaged with the medical community in terms of how to optimally use it.

It's up to us to engage and identify the partnerships that we need and make sure we are very partner oriented, patient focused and [that] we're having those conversations.

What are your goals and milestones?

The ultimate goal is to get more patients to be on Rytelo.

In lower-risk MDS, you have 10,000 to 15,000 patients in the U.S. who can benefit from Rytelo … we are way below that number as the starting point.

We have a very good label. We have an even better [National Comprehensive Cancer Network] guideline endorsement. We have the funding, we have the team. We’ve got to get to work, and it has to be in a very concerted way [that’s] account focused.

And even a great drug doesn't sell itself, right?

Yeah. Absolutely. [With] the typical lower-risk MDS patient, 80% of them are treated in the community. So you have a community physician who's treating all kinds of oncological and hematological patients. They're probably more geared to some of the larger tumor types, like breast cancer, for example, or lung cancer.

So [with] the need for education and putting lower-risk MDS front and center [with] Rytelo as an option for those patients, it becomes a very important task that we can help with.

A report from the Make America Healthy Again Commission was postponed in 2025, but nestled within leaked documents is a strategy that reveals more about health leaders’ goals, including potential new oversight of pharma’s direct-to-consumer advertising practices.

DTC advertising has long been a target of HHS Secretary and MAHA monarch Robert F. Kennedy Jr., and Congress has taken some interest in passing a ban on those ads, but real reform has yet to arrive.

Ultimately, health leaders may seek to crack down on DTC ads, particularly on social media where telehealth companies use “deceptive” marketing tactics, according to draft strategy documents published by Politico. The leaked draft strategy contains policy recommendations from a group assembled by President Trump and Kennedy, and its objectives could change before the official version is published. The White House stated it delayed the report’s release to coordinate the schedules of officials involved in creating it, Politico reported.

The administration released its first MAHA report earlier in 2025 that identified several problems in the nation’s food and health system, directing the commission to formulate policy ideas and plans to address those problems. The first report came under fire for factual errors and alleged use of AI.

Based on the draft strategy for the second report, pharma should brace for heightened scrutiny of DTC advertisements.

DTC oversight

In the past, Kennedy has suggested that pharma DTC advertising should be outlawed completely, but the drafted strategy appears to take a softer approach. Rather than seeking an outright ban, the recommendations are significantly less impactful to pharma’s status quo. 

Listed under “policy reforms” within the draft, the focus on DTC advertising states that the FDA, HHS, the Federal Trade Commission and Department of Justice would “increase oversight and enforcement” under current laws for DTC prescription drug advertising violations. Instead of focusing on all media platforms, the agencies will "prioritize the most egregious violations,” such as those by social media influencers and telehealth companies.

While less strict than a ban, the proposal isn’t new, and some lawmakers want the FDA to crack down. 

U.S. Senators Dick Durbin, D-Ill., and Dr. Roger Marshall, R-Kan., introduced the Protecting Patients from Deceptive Drug Ads Online Act last February, that would target social media influencers and telehealth companies by closing what they refer to as legal loopholes for pharma advertising. Oversight of telehealth companies by the FDA has been questioned for several years, according to legal experts at Foley & Lardner. The bill would clarify the FDA’s jurisdiction over telehealth companies that advertise prescription drugs.

The MAHA commission, it would appear, also believes the FDA should be able to regulate these ads. But while the bill would impose civil penalties on telehealth companies or social media influencers who disseminate false or misleading drug information, the draft strategy doesn’t outline specific consequences.

The health agencies might not be able to enact a ban on DTC ads on their own.

“HHS/FDA likely lack statutory authority to prohibit DTC ads, but there are ways that the administration could pursue limiting DTC ads,” said Jennifer Bragg, partner at Latham and Watkins. “One such mechanism would be requiring more robust disclosure of a drug’s side effects by amending FDA’s regulations … to require the ‘true statement of information in brief summary’ to more exhaustively discuss side effects, perhaps for a predetermined period of time in any advertisement or promotional communication.”

A ban isn’t entirely out of the question — it just may come from Congress rather than health agencies. Lawmakers introduced a bill in 2025 that would ban DTC ads called the End Prescription Drug Ads Now Act. The bill was referred to the Senate Health, Education, Labor and Pensions in June before Congress recessed for the summer, and the earliest action wouldn’t come until after the legislature reconvenes in September.

DTC evolution

As the reform discussion heats up and the MAHA Commission finalizes policy plans, drugmakers continue to approach DTC marketing in new ways.

Several companies, including Pfizer, Eli Lilly and Novo Nordisk have launched DTC channels where patients can reach healthcare professionals and receive prescriptions. AstraZeneca also launched its own DTC delivery platform for its self-administered flu vaccine, FluMist. 

The Trump administration has also sought to limit pharma industry middlemen and lower drug prices by asking companies to sell their products directly to Americans at the same price that other nations pay.

If reforms from either the health agencies or Congress come to pass, it’s likely pharma will fight back through legal challenges.

“The avenues to challenge such a reform depend on the precise mechanism implemented,” Bragg said. “Either way, this is a hotbed area for 1st Amendment challenges given the protections afforded to truthful, non-misleading speech, including commercial speech.”