Healthcare Brew covers pharmaceutical developments, health startups, the latest tech, and how it impacts hospitals and providers to keep administrators and providers informed.

Healthcare Brew

Will Peischel

Healthcare Brew delivers the latest news and trends in healthcare.

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A mountain of pharmaceutical pills in front of the US capital building

Could march-in rights drive down drug costs?

The Biden administration’s quest for lower drug costs may lead to a 1980 law.

Could this federal guideline drive down drug costs?

Maia Anderson

Shelves filled with brightly covered products

Nearly a third of independent pharmacies at risk of closure in 2024 

The pharmacies are feeling the strains of a CMS rule that went into effect at the start of the year. 

Shannon Young

A pharmacist measures someone's blood pressure

How the role of pharmacist has changed

Pharmacists take on a lot more clinical responsibility today, like vaccinations and prescribing certain medications. 

Pharma

A cartoon image of Kristina Monllos created by Morning Brew

Kristina Monllos

Seasoned TV watchers are probably accustomed to the ebb and flow of pharmaceutical ads, when depictions of relief are followed by a reminder to talk to a doctor about a particular drug, which then leads into a speedy rundown of the potential side effects of said drug.

Those ads, let alone how pharma companies advertise altogether, could soon be changing. President Donald Trump on Sept. 9 signed a 

 to the Department of Health and Human Services (HHS) and the head of the FDA that would get rid of the 1997 “adequate provision” loophole, which lets prescription drugmakers summarize safety and risk information in TV ads and direct consumers elsewhere to get additional information.

 that it would send thousands of letters to pharma companies warning them to bring their ads into compliance, and sent an estimated 100 cease-and-desist letters to companies it claimed were running “deceptive” TV drug ads. In mid-October, the FDA published 12 more letters to pharma companies targeting other advertising channels, including websites, newsletters, and social media, 

According to the Sept. 9 memorandum, the White House claims it’s aiming “to ensure transparency and accuracy in direct-to-consumer prescription drug advertising,” arguing that drug ads can be misleading and could promote taking medications over lifestyle changes.

Policy changes typically go through a formal rulemaking process, often taking between two and three years to finalize, and the move falls short of a 

 on pharmaceutical advertising that HHS Secretary Robert F. Kennedy Jr. promised during his presidential campaign. But Kennedy’s comments about pharma ads have remained steadfast: In a Sept. 9 release from HHS, he 

 “pharmaceutical ads hooked this country on prescription drugs” and said HHS “will shut down that pipeline of deception and require drug companies to disclose all critical safety facts in their advertising.”

Direct advertising has become a crucial way that pharma brands reach consumers, and experts say drugmakers are watching potential new rules closely, especially as the proposed changes seem poised to make reaching consumers more burdensome.

Pharmaceutical companies spend billions on advertising each year, with one 

 from the Dartmouth Institute for Health Policy and Clinical Practice estimating that spending grew from $2.1 billion in 1997 to $9.6 billion in 2016. In the first three months of 2025 alone, drugmakers spent an estimated $729.4 million on commercials for the top 10 pharma brands, nearly 30% more than they spent a year prior, according to iSpot data reported by Fierce Pharma.

That spending can have real results. The Campaign for Sustainable Rx Pricing, a nonpartisan advocacy group, has claimed that increases in DTC advertising result in increases in both prescription drug spending and product revenue, and drug manufacturers can also write off DTC advertising expenses to reduce tax bills. 

Perhaps unsurprisingly, then, pharma company leaders are unhappy about the proposed changes.

Alex Schriver, SVP of public affairs at PhRMA, the drug industry’s top lobbying group, said in a statement that its members are “committed to responsible advertising” and that removing the adequate provision requirement would “make it harder for patients to access valuable information they need to have meaningful conversations with their doctors.”

Kyle Faget, a healthcare practice group partner at the law firm Foley & Lardner, said closing the loophole could make broadcast pharmaceutical advertising “very expensive and very difficult” because drugmakers would likely have to buy larger and costlier ad spots to fit in the required disclosures.

Most TV ads would then likely come from the biggest pharma companies, since they’d likely be the only ones able to afford to advertise, Faget said.

Michael McNamara, managing director at McKinney Health, a full-service ad agency that works for healthcare clients, also expects that pharma advertisers may have to “significantly” change their TV advertising to comply, which could lead to longer ads. If advertisers need to buy 30 more seconds of airtime to spell out more safety and side effect information, “that’s going to cut down on your spend and cut down on your creative opportunity," McNamara said.

If ads for pharmaceutical products have to spend more time reviewing side effects, that could leave less room for brand messages, which could prompt some companies to pull out of TV advertising and redirect spend into other efforts, like doctor promotion or patient advocacy.

“​​We could see companies shifting their budgets more to [healthcare professional] advertising,” Steve Boller, VP and executive director of health for ad agency Dunn&Co, said. “Anybody that advertises to [healthcare professionals] already knows that you have to be credible and factual and specific with those audiences.”

But that form of advertising could also be under the microscope: Some of the cease-and-desist letters indicate a review of “promotional communication” for certain drugs on certain healthcare provider-branded websites.

McNamara predicts that any change to disclosure requirements could prompt a shift to “unbranded advertising,” meaning that instead of advertising a specific drug brand, ads would focus on the condition the drug brand is designed to treat. For example, a pharmaceutical advertiser that would have previously produced ads for a product targeting psoriasis could instead make ads about patients with the condition, focusing on symptoms they may have and suggesting a conversation with a doctor.

“They can do that in 15 seconds or 30 seconds,” McNamara said. “There’s no safety information, no side effects, and they can still initiate a conversation with the doctor. What you have to remember in all these cases: [This is] the goal.”

Of course, without knowing more about the rules or its enforcement mechanisms, the exact effects can be hard to pinpoint. “Like everything else with this administration, you just kind of play it day by day and see where things go,” he said.

When reached for comment, an HHS spokesperson directed us to the White House. White House spokesperson Kush Desai said the Sept. 9 memorandum “instructs HHS to increase oversight of misleading advertisements in accordance with federal law so Americans are better informed about their health decision-making.”

What’s even more unclear is how any rule change could affect telehealth companies like Ro and Hims & Hers, which have used TV advertising to promote compounded GLP-1 products amid a surge of interest and ad spend behind the drugs. Because compounded drugs are not FDA-approved, they are not currently held to the same disclosure standards as approved drugs on the market.

 from Hims & Hers that aired earlier this year was 

 by health experts and lawmakers, who argued the ad was misleading and failed to disclose side effects.

Whether the FDA has authority to regulate telehealth companies’ advertising practices is something that’s been debated for years, according to Faget. “Unless somebody really wants to litigate it in some way, shape, or form, it’s unlikely that you’re going to see that playing out to get a real answer,” she said.

There has been some movement to change that. In February, Senators Dick Durbin, a Democrat from Illinois, and Roger Marshall, a Republican from Kansas, introduced the Protecting Patients from Deceptive Drug Ads Act, which would 

 the FDA to regulate “misleading prescription drug promotions” from telehealth companies and influencers. But so far, no action has been taken on the bill.

While the FDA has said it plans to take “aggressive enforcement” action in the wake of the memorandum, the agency didn’t specify what that may look like and didn’t respond to a request for comment by publication.

In a Sept. 9 press release announcing the policy change, the FDA said it plans to send hundreds of enforcement letters to pharmaceutical companies if necessary, but doesn’t detail any further action. In the meantime, pharma companies and advertisers are in a holding pattern as they await further information.

But pharma companies typically come into compliance quickly when receiving an enforcement letter because they rely on the FDA to approve their products, Faget added.

“There are very few manufacturers out there that want to make an enemy of the FDA,” she said.

A flatscreen TV shows a medical cross on its screen before it flashes to TV static.

What new advertising rules may mean for pharma companies 

The Trump administration’s crackdown on direct-to-consumer pharma ads could make TV advertising “very expensive and very difficult,” one expert said.

illustrated headshot of caroline catherman, healthcare brew reporter

Caroline Catherman

Biopharmaceutical company Spruce Biosciences’s stock surged 

That was on Oct. 6. Since then, the late-stage startup has announced $50 million in private financing, with its stock peaking at $240 on Oct. 7.

 found stock prices on average increase 5.8% after breakthrough therapy designations, which speed up the drug development and review process for potentially transformative drugs.

Of course, investors and scientists’ opinions don’t always line up. Take 

, an ultimately failed Alzheimer’s drug that attracted investor attention and millions of funding, catapulting creator Cassava Sciences to a valuation of $5 billion in 2021, even while scientists 

In this case, however, preliminary data has scientists feeling optimistic—with caveats.

The therapy, tralesinidase alfa enzyme replacement therapy (TA-ERT), treats Sanfilippo syndrome type B, a rare fatal disease with no available cure, with doses weekly or biweekly.

This syndrome occurs when babies are born without an enzyme that breaks down a specific sugar, which then accumulates to a toxic level, leading to childhood dementia and death, according to nonprofit the Cure Sanfilippo Foundation.

 published on Spruce Biosciences’s website in August suggest its therapy reduced this sugar to “normal or near-normal” levels over a five-year span in cerebral spinal fluid by artificially replicating that missing enzyme.

Patricia Dickson, professor and chief of the division of genetics and genomic medicine at Washington University School of Medicine in St. Louis, told us these results suggest the drug is working.

“I think this is the best thing that is in the pipeline [for this disease],” Dickson told us. “It’s a very promising therapy.”

The drug also appeared to stop cognitive decline, according to the preliminary results, though patients didn’t seem to progress past the toddler-level cognition they had when they started treatment.

However, Rita Redberg, a cardiologist and professor of medicine at the University of California, San Francisco, who researches drug and medical device regulation, told Healthcare Brew via email she feels this data is “weak and preliminary.”

This data is not from a double-blind randomized controlled trial, she said, which is considered the most rigorous way to determine a cause-and-effect relationship. Instead, Spruce Biosciences’s research compared treated patients to untreated patients whose disease progression was tracked in a 

 has been peer reviewed, the full August data has not, and there isn’t a public timeline for when that might happen yet, Spruce Biosciences President and CFO Samir Gharib told Healthcare Brew via email.

Kim Hemsley, head of the childhood dementia research group at Australia-based Flinders Health and Medical Research Institute at Flinders University, told Healthcare Brew via email that she believes double-blind randomized controlled trials are “unethical” for rapidly progressing childhood dementia-causing disorders. In instances like this, she added, when the disease’s typical progression is well documented and predictable, there’s a very short window to intervene, and children might miss it if they’re part of an untreated control group.

 in journal Frontiers of Neurology notes natural history studies can be used as control cohorts when a placebo-controlled study would be “difficult or unethical.”

Before this upturn, Spruce Biosciences was struggling. After multiple drugs for rare endocrine disorders had failed, the company 

 over half its staff in April—an estimated $1 million expense.

Now, according to an Oct. 6 press release, the company plans to submit a biologics license application—a request to the FDA for permission to start marketing the drug—in Q1 2026.

An Oct. 6 report from investment banking firm Jefferies found about 72% of treatments that have gotten breakthrough therapy designation since 2013 eventually get FDA approval.

“On the basis of the data obtained thus far, I sincerely hope TA-ERT advances under the 

A doctor dispenses a pill from a prescription bottle for a patient, its trajectory forms a price increase graph.

The science behind the therapy that catapulted Spruce Biosciences’s stock 1,400% and counting

Spruce Biosciences saw its stock soar after months of decline, thanks to a new drug for a rare disease.

The science behind the therapy that catapulted a biopharma’s stock 1,400% and counting

Cassie McGrath

It’s no secret US drug prices are much higher than the rest of the world—nearly 2.8x higher for branded and generics in 2022, in fact, the Department of Health and Human Services 

 about the cost of drugs in the US, and health research organization 

 over half of adults in the country are “very worried” or “somewhat worried” about affording their prescription medications.

Both public and private solutions have come forward to address these expenses, including the $35 insulin cap established in the Inflation Reduction Act or drug discount companies creating initiatives like 

 and direct-to-consumer (DTC) options like billionaire Mark Cuban’s 

On Sept. 30, the Trump administration announced a new public-private program to lower drug costs. Called TrumpRx, the partnership with pharma giant Pfizer intends to sell drugs directly to patients at prices 40%–85% cheaper than usual and doesn’t go through insurance, according to press releases.

The administration said patients can navigate to TrumpRx.gov starting in 2026 and find price discounts for drugs from Pfizer, including topical ointment Eucrisa, arthritis medication Xeljanz, and migraine treatment Zavzpret.

While the program started with Pfizer—boosting its 

 after the announcement and helping the company potentially 

 for three years—the administration said it plans to expand its partnerships. As of Oct. 10, it has already started that process, announcing a partnership with AstraZeneca that offers discounts ranging from 96% to 654% off the undefined “deal price” of three respiratory drugs. Exact prices are still private, however.

“Anything that makes drugs—particularly new drugs—more accessible to consumers is a positive,” Gary Zammit, president and CEO of contract research organization Clinilabs, told Healthcare Brew. “What is yet to be seen is whether or not other pharmaceutical companies will come on board and to what extent the benefits of TrumpRx will be extended to the general population.”

Programs to lower drug prices are not new. In fact, the Trump administration and Pfizer’s DTC partnership is similar to the Cost Plus Drugs model, where patients purchase medication directly from drugmakers, avoiding pharmacy benefit managers (PBMs) and providing options for people without insurance.

, and these DTC programs like TrumpRx and Cost Plus Drug intentionally avoid the intermediary.

Cost Plus Drugs is mostly for generics, however, whereas the Trump administration is taking a company-by-company approach to expand into branded drug discounts.

Cost Plus didn’t respond to a request for comment, though its founder, Cuban, wrote in 

 the same day as the announcement that the initiative “will be amazing” for Cost Plus’s business since its “overhead and markups are lower than everyone else.”

But Rajiv Leventhal, senior analyst in digital health at research firm eMarketer, told us there isn’t a big difference between TrumpRx and what already exists on the market.

Big pharmaceutical companies already have DTC sites, 

 by Eli Lilly, Pfizer for All, and NovoCare through Novo Nordisk. These sites also offer discounts: For example, customers can get 50% off Lilly’s popular weight loss medication Zepbound through Lilly Direct.

Around the time of the program announcement, more companies (including Amgen and AstraZeneca) launched their own DTC websites to sell medications, potentially opening the door for them to distribute drugs through TrumpRx in the future, Leventhal said.

Still, “there’s really no difference here,” Leventhal said, except TrumpRx is creating one central marketplace to make it easier for patients to find the DTC offerings.

“It’s not going to affect most people, and that’s because the drugs are still going to be very high [in price],” he said, adding that most people get their medications through insurance and typically only pay out of pocket if they have a high deductible or the drug isn’t covered by their plan.

Zavzpret, for example, can cost over $1,000 out of pocket for six doses, according to Leventhal and drug price comparison company SingleCare. Even if the medication is discounted 50%, $500 would still be out of reach for most people, he said.

“There’s probably a small subset of patients that maybe can save some money through these offerings, but I would say it’s a very small subset,” Leventhal said.

What’s TrumpRx, and how does it compare to other DTC options?  

Experts say it’s not so different from existing choices, like drug discount company Cost Plus Drugs.

I like some of Fujifilm’s cameras. But what does it know about pharmaceuticals?

And on Sept. 24, its drug manufacturing arm Fujifilm Biotechnologies made its next big investment: a $3.2 billion facility in Holly Springs, North Carolina, part of the state’s biotech hub—aka the Research Triangle.

Fujifilm Biotechnologies launched as a drug manufacturer in 2011, making a big shift into healthcare as its film business was failing. Over the last almost 15 years, the company has found success in this model, reporting $2.1 billion in revenue for its healthcare segment in Q4 2025.

In 2006, Fujifilm lost a significant portion of its revenue when digital cameras took over and the company could no longer make as much profit from physical film, Lars Petersen, president and CEO of Fujifilm Biotechnologies, told Healthcare Brew.

So the company began to pivot toward healthcare and launched a research lab in Japan in 2006. Then, five years later, Fujifilm had an opportunity to buy two manufacturing facilities reportedly worth 

 from drug company Merck: one in Morrisville, part of the Research Triangle Park, and one in Billingham, England. It also marked Merck’s transition out of the biologics business, 

That marked the official launch of Fujifilm Biotechnologies.

The company now has 10 manufacturing sites across the US, the UK, Japan, and Denmark, including the new site in Holly Springs (its second in the Research Triangle Region).

While it may seem weird for a camera company to manufacture medications, “it’s not strange at all,” Pankit Bhalodia, partner at consultancy West Monroe, told us.

Camera companies like Fujifilm are already good at engineering, he continued, meaning they are well positioned to make other complex products—like medications.

Kodak, for example, took a similar path and entered into pharmaceutical ingredient production in 2020, 

 As a contract development and manufacturing organization (CDMO), Fujifilm Biotechnologies doesn’t work in drug development but instead has contracts with drug companies to make their medications. Those include a $3 billion contract with biotech Regeneron signed in April and a $2 billion deal with Johnson & Johnson in August.

The CDMO industry is currently valued at $139.3 billion, according to 

, and is expected to grow to $273.9 billion by 2034.

“We are actually proud of calling ourselves a pure CDMO,” Petersen said. “We are not competing with our customers [which are biotech companies].”

The camera maker has also had previous partnerships with Eli Lilly as well as Japanese drugmaker Takeda Pharmaceutical Company.

A lot of pharmaceutical companies are announcing 

 in the face of the Trump administration’s tariffs. But this new Fujifilm facility was planned back in 2021, Petersen said, “far before anybody thought about tariffs.”

The building is instead part of the company’s business model, dubbed kojoX, which establishes the concept of facilities designed as replicas of its other buildings around the world, so they can therefore make the same products using the same tactics.

Having an international footprint is also a benefit to biotech companies looking for drug manufacturers, Bhalodia said, as it helps diversification and avoids “geopolitical risk” so companies can make strategic decisions about where in the world would be best to make their product. 

“It gives them the flexibility to leverage, whether it’s the Europe-, Asia-, or US-based facility,” he said. “It’s probably a larger strategic play to become a more global CDMO.”

Cambridge, USA - 26 July 2024. A colorful facade wraps around FUJIFILM Diosynth Biotechnologies, blending science and design in a playful, modern exterior and street reflections.

Fujifilm Biotechnologies builds new manufacturing facility in North Carolina’s Research Triangle 

From cameras to drug manufacturing, Fujifilm is staking its claim in the pharmaceutical industry. 

Although the psychedelic medicine industry faced a significant setback in late 2024 when the FDA 

 a front-running MDMA-based treatment, healthcare 

In fact, AbbVie, one of the largest pharmaceutical companies in the US, 

 in August plans to drop more than $1 billion to acquire a psychedelic drug in development from Gilgamesh Pharmaceuticals.

With states continuing to introduce and pass legislation to 

 psychedelics, Healthcare Brew asked leaders from across the industry their thoughts on psychedelic medicines, how they’re being integrated into the healthcare system, and what work still needs to be done.

Rachel Yehuda, endowed professor of psychiatry and neuroscience of trauma at Mount Sinai in New York, told us the healthcare industry is “in a transitional moment with psychedelic medicine.”

“We’re seeing growing interest from traditional institutions, including academic medical centers, government agencies like the Department of Veterans Affairs and National Institutes of Health, and pharma,” Yehuda said.

However, it’s still early days, as it’s hard to conduct clinical trials for psychedelic medicines and there are still “too few,” she added.

Mount Sinai in 2021 opened a psychedelic research center, renamed the Parsons Research Center for Psychedelic Healing in 2024, because the hospital believes it’s “essential to bring scientific rigor, clinical safety, and ethical clarity to this emerging field,” Yehuda said.

In order to safely integrate psychedelics into healthcare, key priorities should be making sure clinicians are trained properly, ensuring historically underserved communities 

 to the treatments, and conducting ongoing research, she added.

Jerry Rosenbaum, psychiatrist-in-chief emeritus as well as founder and director of Mass General Brigham’s Center for the Neuroscience of Psychedelics in Boston, told Healthcare Brew that while there’s uncertainty around the logistics of how psychedelic medicines may be delivered and reimbursed, he thinks it’s very likely several will eventually work their way through FDA approval.

That’s because some research suggests psychedelics are effective in treating or reversing many psychiatric conditions without the need for daily medication and are also often effective for patients who haven’t responded to existing treatments, according to Rosenbaum.

Psychedelics are most poised to treat psychiatric conditions such as treatment-resistant depression, generalized anxiety disorder, PTSD, obsessive-compulsive disorder, and substance use disorders, he said.

 on MDMA as a treatment for PTSD, for example, found 71% of 104 patients no longer had symptoms meeting PTSD criteria after treatment. And a 

 from psychedelic medicine company Usona Institute found psilocybin treatment was associated with a “significant sustained reduction” in depression symptoms.

Mass General Brigham founded the Center for the Neuroscience of Psychedelics in 2021 to “understand how psychedelic molecules act to change the brain in hopes of deepening our understanding of psychiatric conditions and to facilitate the discovery of novel therapies,” Rosenbaum added.

Andrew Whitman, a clinical pharmacist in hematology and oncology at UVA Health in Charlottesville, Virginia, told Healthcare Brew psychedelics have the potential to be particularly impactful for cancer patients.

“A lot of patients are dealing with the distress from cancer diagnosis and existing depression [or] anxiety. There’s a trauma response associated with the cancer diagnosis,” he said.

In his experience, providers in the oncology space are generally open to exploring psychedelic medicines since they work with such a vulnerable patient population, Whitman said.

 from Johns Hopkins found psilocybin therapy helped combat depression and end-of-life anxiety in cancer patients.

A potential benefit psychedelics could have is to allow providers to deprescribe other medications and be more minimalistic when it comes to prescribing, Whitman said. That way, patients don’t have to take medication every day.

“You’re really putting the work into working through the underlying cause…so it shifts that focus from daily use to a more holistic approach to making sure patients are being taken care of,” Whitman said.

However, psychedelics don’t work for everybody. There’s concern for people with conditions such as bipolar disorder or schizophrenia because psychedelics may potentially exacerbate their condition, Whitman added.

Leonardo Vando, medical director for Mindbloom, a telehealth company that provides ketamine therapy, told Healthcare Brew that while stigma around psychedelics still exists, he’s starting to see the healthcare system embrace the treatments.

“Academic medical centers are leading clinical trials, and health systems are increasingly exploring what it could look like to integrate psychedelic care responsibly. Even insurers are 

 closer attention,” he said. “We’re still in the early stages, but momentum is building.”

The three areas of focus to bring psychedelics more into the mainstream are research, access, and education, Vando said.

The industry needs to continue conducting rigorous research on psychedelics, as well as make sure the medicines are “affordable, scalable, and available to people from all walks of life, not just those with privilege or proximity to major research institutions,” he said.

And education is needed to combat misconceptions that psychedelic medicines are experimental or risky, Vando added.

“If we can deliver these treatments with compassion, structure, and integrity, they won’t just join the mainstream; they’ll help reshape it,” he said.

Healthcare execs on the state of psychedelic medicine 

While there’s still a long way to go, the industry is starting to embrace psychedelics. 

Whether you’re a doctor checking on the devices you use, a manufacturer learning from others’ mistakes, or you just like drama, you need to know about recent FDA medical device recalls.

Every year, the FDA gets 2+ million reports of deaths, injuries, and malfunctions suspected of being linked to medical devices. The agency then issues recalls with corrections ranging from making tweaks to pulling a device off the market.

Healthcare Brew provides a monthly summary of some recent Class I recalls, the most dangerous kind.

Without further ado, here is September’s Recall Roundup!

Several components of Medtronic Cardiac Surgery’s DLP left heart ventricle catheter have been recalled because the catheters “may not retain their shape.” Medtronic told users to quarantine affected lots.

Some lots of 3M Company’s Ranger blood- and fluid-warming high-flow sets are labeled as being able to warm blood and plasma at high flow rates, when in fact the system can only keep blood and plasma appropriately warm at lower flow rates. The company has communicated the device’s actual abilities to customers and said they should follow those guidelines.

Abiomed has told users to “quarantine and cease use” of certain brands and product codes of automated Impella controllers because they could lead to decreased performance or even stop the Impella heart pump. This issue has been associated with at least one death, according to an August FDA early alert.

Medline’s medical device reprocessing program, Medline ReNewal, has added to 

 recall of certain St. Jude Medical’s Response and Supreme electrophysiology catheters. Several more Medline ReNewal’s reprocessed electrophysiology and ultrasound catheters may contain “small residual particulates” that could infect patients or cause other issues.

Dexcom has told users to update software on their continuous glucose monitor G7 and One+ iOS, watchOS, and Android apps to the latest version. Past software versions didn’t always alert users when the sensor failed.

 Olympus has told users not to use and to return affected units of its ViziShot 2FLEX (19G) endoscopic single-use aspiration needle because tips could be deformed in an undetected way. There have been 40 reported injuries and a death related to this issue as of Sept. 30, according to the FDA.

A few of Medline’s “sterile” convenience kits were never actually sterilized, and customers were told to return impacted products.

Permobil is warning users and distributors to “immediately” discontinue the use of the Max Mobility/Permobil SmartDrive MX2+ wheelchair speed control dial. There’s a risk of faulty electrical connection between the controller and the wheelchair’s motor, potentially causing the device to lose control

Mashup of hospital symbol, stethoscope, IV bag, oxygen tank, and other medical devices on orange background

Recall Roundup: September 2025

One of this month’s recalls gives new meaning to being “cold-blooded.”

 that it had opened two new national security investigations, also known as Section 232 investigations, into personal protective equipment (PPE) and medical items as well as robotics and industrial machinery imports.

These investigations are a signal of possible tariffs on these products, as they ask companies to report how devices and their parts can, among other things, “meet domestic demand.” The probe began on Sept. 2 but wasn’t reported publicly until last week.

 in a Truth Social post 100% tariffs would be coming for certain imported drugs unless parent companies have started building a facility on US soil by Oct. 1. That’s 

 around whether pharmaceutical tariffs were coming and what they would look like. (In August, President Donald Trump 

As of publication, there are no specific tariffs on medtech or pharmaceuticals, though there 

 on goods from China and 20.8% for the rest of the world. Professional supply chain organization the Association for Health Care Resource and Materials Management reported these tariffs could increase hospital expenses “by at least 15%.”

“At the end of the day, tariffs are essentially a tax on fragility. Without smart exemptions and faster investment in domestic capacity, we risk raising today’s prices without actually protecting tomorrow’s supply,” Pankit Bhalodia, partner at consultancy West Monroe, told us in an emailed statement.

Mergers and acquisitions (M&A) in the medtech industry have been down so far this year, 

, which found there were 104 transactions in Q2 2025, compared to 128 in Q2 the year prior.

Managing director at PMCF Bryan Hughes told Healthcare Brew this can be connected to tariff-related market “uncertainty.”

“The tariffs have obviously been all over the place, and what we’ve seen is it’s really paused a lot of discussions around potential M&A activity, as well as other investments,” he said.

While Hughes said he’s watching to see how the Section 232 affects the market, he thinks activity will still remain slow amid the uncertainty. Otherwise, he’s keeping an eye on products like gloves, masks, and gauze, which are 

“I don’t think anyone knows what’s going to happen with tariffs,” he said, but there’s “much less room to absorb some of that cost pressure” from PPE used every day compared to medical devices.

These incoming pharmaceutical tariffs could impact $229 billion in drug imports to the US, the 

Big biotech companies like Johnson & Johnson, Eli Lilly, and GSK are dealing with tariffs by announcing new investments in US manufacturing facilities. Pfizer also 