Postscripts Rx
Conversations Beyond the Prescription. Where pharma, HCPs, life science and digital health solutions meets patients—after the script is written. Conversations on digital health, engagement, and real-world impacts that are re-writing the future of patient engagement.
Postscripts Rx
Why Your Medicine May Soon Say "Made in America"
The pharmaceutical landscape is undergoing a seismic shift as the Trump administration drops a bombshell 100% tariff on imported branded and patented drugs, effective October 1st. This game-changing policy mandates that pharmaceutical companies build manufacturing plants on American soil or face potentially devastating market consequences.
We dive deep into the multifaceted implications of this dramatic policy shift that has already prompted nearly $20 billion in promised pharmaceutical manufacturing investments across the United States. The tariff represents a fundamental pivot toward economic nationalism in healthcare, framed around dual imperatives of national security and domestic job creation following the supply chain vulnerabilities exposed during the COVID pandemic.
For pharmaceutical brand marketers, this creates unprecedented communication challenges as companies navigate how to maintain brand value when prices may potentially double overnight. Patient access teams must rapidly scale copay assistance programs and develop new financial navigation resources to prevent affordability barriers. Meanwhile, innovation teams face profound questions about where research and development should physically occur, potentially fragmenting the collaborative global research model that has accelerated breakthrough therapies.
The operational dimensions cannot be understated—building FDA-compliant facilities requires substantial time and expertise, with procurement teams facing the complex task of securing U.S.-based contract manufacturers and redefining supply chains when 79% of active pharmaceutical ingredients are currently imported. This transition creates new cybersecurity concerns as domestic facilities handling sensitive biologic intellectual property become targets for industrial espionage.
Digital patient engagement platforms will become increasingly critical during this transition, offering pharmaceutical companies their most direct pathway to maintaining patient relationships while navigating affordability challenges. The administration has promised expedited regulatory approvals for new manufacturing facilities, potentially creating a new American era of biopharmaceutical independence—if executed thoughtfully and inclusively.
Subscribe to Postscripts for ongoing analysis at the intersection of pharmaceutical policy, technology and patient impact as this watershed moment continues to reshape the healthcare landscape.
PostScripts Rx is not intended to constitute medical advice, nor is it intended to influence prescribing decisions or any other medical or clinical decision-making. All medical and clinical judgment and decision-making, prescribing decisions, and all related considerations remain exclusively the responsibility of providers and patients.
Welcome to Postscripts, where we cover the latest innovations in patient access, support, digital tools, HTT engagement, and pharma marketing that we all hope drive better outcomes for patients. This podcast is for informational purposes only and does not constitute medical advice, nor should it be used to influence any clinical decision making. Patients should always consult their healthcare professionals. Welcome to the podcast. My name is Brian Carr. I'm from the MetaSafe team, although any opinions expressed here are my own and not necessarily those of MetaSafe and its partners. Well, we all woke up this morning to a game-changing tariff hitting the industry as President Donald Trump announced the sweeping policy change, sending ripples across the global pharma industry. Which, if you've been following the podcast, you know we've been following this very, very closely for the past four or five weeks here, that there's now a hundred percent tariff on imported, branded, and patented drugs that goes into effect on Tuesday, October 1, actually Wednesday next week, unless pharmaceutical companies start building plants in the United States to manufacture these products domestically. So we've been talking about this on the podcast, all the almost$20 billion or more in investment that pharma companies have promised over the past two or three weeks in building plants, whether it's Virginia, Texas, California, that they're promising to build by 2030, and how that would probably get them better terms when it came to tariffs coming from medications that are inbound to the U.S., basically getting slapped with the tariff. And it is happening as we speak. So the administration is actually falling through. So it is a turning point, not just in the U.S. with trade policy, but in how the pharma ecosystem is evolving to address these shifting economic pressures, regulatory realities, and cost structures. We're going to explore what this means for pharma brand marketers, innovation teams, patient access and support leaders, procurement, supply chain, IT, security professionals, and then of course the C-suite of pharma and what they're doing about this. So we we're gonna evaluate the ripple effects across the market dynamics, what happens with patient pricing, manufacturing strategy, global partnerships, and those implications for the future state of pharma innovation, clinical trials, for example, in the United States. So first, let's just do a foundational take here on what is the policy and why now. So the proposed tariff, it's part of a broader push toward economic nationalism we're seeing in the U.S. and reshoring in the U.S. of manufacturing capabilities. The argument from policymakers is twofold. One, national security, uh especially with some supply chain challenges that we saw happen through COVID, not only in products and goods, but pharmaceuticals as well, and job creation in the U.S. So, according to the announcement that was on uh CNBC, I'll put all the sourcing in the in the show notes, the drugs made overseas, especially in countries like China or India, pose this dependency risk. And reshoring manufacturing could bring tens of thousands of jobs back to the U.S. facilities, increasing uh workforce competitiveness. Eli Lilly this week announced a Texas plant, and alongside that was the potential for 1,500 new jobs in Texas, right? So pharma isn't like textiles or semiconductors, where we saw those supply chain challenges happening during COVID. It's not just about the machines and labor, it is about an ecosystem of science, supply chain precision, clinical partnerships, and data integrations. So, what's the reality behind the good intentions? Well, for brand marketers, what happens, what's gonna happen when the price becomes taboo, right? So for brand marketers, this 100% tariff is gonna force a massive recalibration of positioning, promotion, pricing strategies, right? Attention's gonna shift from scientific innovation and economic justification as U.S. prices for branded imported drugs may double overnight in the absence of domestic manufacturing moves. So we've seen studies where there was one in uh health affairs where 77% of Americans already report that prescription drugs are too expensive. So introducing a tariff-related additional spike is just going to increase public scrutiny and likely draw regulatory attention. So can consider you're a brand marketer, the teams have to prepare to communicate clearly and ethically why branded drugs are costing more without alienating those prescribers or patients. Reframe the brand straight, reframe those brand strategies and stories to include supply chain transparency, domestic commitment to job creation, for example. You're gonna see a lot more of that. Align with the patient support and access teams early to offset affordability concerns, right? So copay cards are gonna become a bigger factor one can imagine, right? If to make sure those prices are staying the same or helping preserve market share, right? So anticipate backlash from payers and advocacy groups and have some of that proactive messaging already ready. This is definitely a moment for brand marketers to lead with values and visibility and not just benefits and efficacy. Innovation teams, the domestic RD, or is it just for manufacturing, right? So the talent policy creates a potential fork in the road. Will companies simply build U.S. space factories or will they move entire RD pipelines stateside? We're already seeing a RD investment in Thousand Oaks, California from one of the major pharma companies, for example, right? So innovation teams are gonna be tasked with determining where in the pipeline localization they'd sense, right? So phase three manufacturing versus early discovery in the phases, right? How IP transfer laws and cost sharing agreements will function in the new regulatory space, that's gonna hit the procurement teams as well. How to qualify for US US-based suppliers so that they're in the good manufacturing compliance projects, right? What about even applying for tax breaks and making sure that the all that is is coming to the fore to help to keep costs in line or increase margin and protect market share? So whether the U.S. has enough scientific and clinical trial infrastructure to support pipeline continuity is going to be an interesting one, although 47% of all clinical trial patients are in the U.S. So you may not see the the the shortages in patients wanting to do clinical trials, but are they going to be happier? And the rollout strategies, right? So if you've got domestic production happening here, you've got clinical trial meds, you want to may want to roll them out in countries where you're already producing the meds. You've already passed all the regulations, for example. So you may see clinical trial, instead of having worldwide launches or you know, regional launches, you may have to readjust where those regional launches are in order, right? So according to a report from Biopharmadive, 60% of new drug trials are conducted outside of the US. Global RD partnerships are driving the pipeline acceleration. So localizing this innovation was requiring not just physical infrastructure, but a mindset shift, right? And a supply chain shift that the raw materials have to be in the US or have to be shipped in the US or produced in the U.S., right? Think about if you're on the patient access and support teams, you know, you get this new era of financial, and I'm going to call it toxicity, right? Perhaps the sharpest pain in this policy would be felt not by companies, but by patients. Drug prices in the U.S., already the highest globally, layering in 100% tariff on branded imports could push certain specialty meds beyond the reach even of the insured patients. So patient access professionals must now architect expanded co-pay assistance pipelines, emergency frameworks for financial navigation and insurance advocacy, longer eligibility periods, perhaps for support programs, integrated digital platforms, you know, like MetaSafe, like we have here, deliver the adherence of information and affordability resources where they matter most at the point of care. So, for example, this the MetaSafe and other platforms, again, they allow for tailored digital journeys, affordability guidance, emotional support resources that patients can actively engage with during therapies, right? As costs are rising, the digital tools are going to be critical, navigating these affordability challenges in real time and creating that one-to-one loyalty and brand with patients, right? Because especially there's other factors at play now for direct-to-consumer advertising, may uh also be restricted. So ads on television and things like that, because they can't have the ISI, the information statements on a full television ad, you may see uh better engagement rates on digital solutions where you end it to click, here's the whole full ISI, things like that. So, you know, procurement and supply chain, consider what's happening there. You're gonna be localizing without breaking the chain. So procurement there, you've got the U.S. policy is gonna set off a high-stakes game of chess, right? Where tariff avoidance requires domestic production, timelines, and resources to stand up GMP certified facilities are not instantaneous. Strategic sourcing will need to adapt on multiple fronts. Key impact areas, securing U.S.-based C DMOs, contract development and management manufacturing organizations, prepared to expand capacity, redefining long-term contracts of raw materials and API producers for U.S. delivery and supply chain security, right? Managing parallel operations both domestically and globally during a transition phase, right? Rebuilding redundancy strategies to avoid critical drug shortages. IQVI has reported that over 79% of active pharmaceutical ingredients used in the US are imported, right? So replicating that ecosystem domestically where it's quickly, affordably, and reliably done, it's not just about costs, it's about survivability now. Pharma IT and cybersecurity, consider that. Guarding the critical infrastructure in tandem with domestic plant building becomes imperative to secure them, right? So, you know, manufacturing facilities, especially those managing sensitive biologic IP, right, will become increasingly attracted to cybercriminals, state actors, and industrial espionage. So IT and security leaders are going to really need to elevate their security practices across the plant level, Internet of Thing, and SCADA systems, FDA inspection and validation data pathways, cross-continental RD collaborations via cloud networks, coordination of those third-party logistics and supplier portals, right? Things like that. So according to a 2024 cyber M and MDX and Philips survey, 77% of healthcare organizations have experienced cybersecurity incidents in the last year, and FRAMA is not untouched. Reshoring doesn't just mean local, it all means local responsibility, right? And regulations. So if you're in the C-suite, you know, you've got strategic planning and political volatility, you know, this moment demands bold but balanced thinking. CEOs, CFOs, COOs are simultaneously managing investor expectations, market stability, operational resource allocation between short-term compliance and long-term sustainability, lobbying and policy-making engagement with trade organizations. International relations is also key with global partners who may feel sideswiped now. According to Delite's 2025 Pharma CEO Outlook, over 64% of CEOs say, quote, geopolitical instability, end quote, is now their top operational risk. I figure out from just 22% five years ago. So 22% five years ago, it's gone up threefold almost to 64%. The tariff's not just going to reshape operations, it's going to demand a recalibration of global growth models that have fueled pharma for the past few decades. Is pharma at the risk of a trade war, right? So consider this. Early hints suggest that global markets could retaliate with similar tariffs on U.S.-made diabetes, oncology, and cardiovascular brand leaders. The biopharma world may fracture from a harmonized global marketplace into regional fiefdoms, each with its own price structures, manufacturing hubs, and regulatory constraints. The fragmentation will raise costs, not reduce them, and slow innovation that thrives in the fluid exchange of clinical, scientific, and technological capital. So are tariffs solving for costs or creating new ones? There are opportunities ahead. Look at the silver linings and long-term games. So there, you know, tariff pressure could spark new investment in American biotech clusters, create faster tech translation from bench to bench side, and really encourage companies to embed cost efficiency into every layer of the product lifecycle, not just post-launch support. So these scenarios are possible if the policy is matched with the robust government support for your GMP infrastructure building. So we have seen some of that with the U.S. administration saying any new plants that are being built in the U.S. will almost get to the top of the line when it comes to approvals from the EPA and the FDA. And they've instructed EPA and FDA officials not to be burdensome with their regulations and their approvals and to speed things along. That was actually written into an executive order on paraphrasing. Workforce development partnerships between industry and academia are going to be important. Regulatory flexibility from agencies, like I mentioned, from FDA to speed these approvals is going to be key. And it's already been brought out by the administration that they expect that. You know, because Pharma went to the administration as this was being spoken about months ago and said, we'd love to build new plants, but it takes five to ten years. We all heard this in the U.S. It's going to take five to ten years to build a new plant. Well, the administration heard that and said, no, we'll get you the top list to get those approvals within, you know, 18 months to two years, right, at the most. So when you're looking at, you know, if they're done right, this could catalyze a brand new American era of biopharmaceutical independence, but it's really going to be done smartly, inclusively, and you know, it's really adaption over reaction, right? So this October of one deadline is fast approaching, and 100% tariff declaration may or may not be fully implemented or scaled back due to political or logistical pressures. The intention is clear. The U.S. government wants a farmer to anchor more of its operations domestically. Farmer leaders across marketing, innovation, access, procurement, and security, the clock is ticking, you build new models, test new messaging, and unite stakeholders across internal silos to build solution first responses. Digital tools like MetaSafe and others, which really engage directly with patients around both access and experience, are going to become even more central in the cost and complexity rich environment. Change is inevitable. What matters now is how quickly and collaboratively the industry can adapt. Well, thank you so much for joining us in Postscripts. If you found this conversation valuable, follow or subscribe for more insights at the Intersection of Pharma Technology and Patient Impact. We have other podcasts on the uh new new guidelines for direct-to-consumer advertising that are hitting as well, uh definitely uh, which is in conjunction with this, and the U.S. administration um basically giving um most favored nation status to those companies that are trying to do direct to consumer pricing, i.e., cutting out middlemen and women. And the administration actually called that out in their executive order that if you're doing direct to consumer advertising, maybe it didn't actually say exempt, but it would be looked upon differently by the administration when it comes to tariffs and other uh reviews. So all right. Have a good day, everyone. Thanks so much.
