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
FDA's Domestic Manufacturing Boost: Reshaping Pharma's Future
A seismic shift is underway in pharmaceutical manufacturing. The FDA's newly unveiled Advanced Manufacturing Technologies Designation Program promises to accelerate reviews for facilities producing drugs and biologics on American soil—potentially slashing approval timelines by up to 40%. With pharmaceutical giants already committing over $20 billion to new domestic production facilities, this represents far more than a regulatory adjustment; it's a fundamental reimagining of what competitive advantage looks like in the industry.
For decades, global outsourcing defined pharmaceutical manufacturing strategy. Cost optimization drove decisions about where and how medications were produced. Then COVID-19 happened. The pandemic brutally exposed vulnerabilities throughout global supply chains—from raw ingredient sourcing in India to manufacturing sites in China—culminating in critical drug shortages that affected countless patients. Remember when some chemotherapy medications had to be rationed in the US? That wake-up call made it clear: a resilient, agile, and secure domestic manufacturing base isn't just nice to have—it's essential.
What's fascinating is how this shift transforms manufacturing from a back-office function into a front-and-center player in patient outcomes. Domestic production doesn't just promise operational margins; it enables consistent drug availability, predictable adherence support, and improved enrollment in patient programs. When paired with digital solutions that can identify moments of patient vulnerability and trigger supportive interventions, this new manufacturing paradigm creates a powerful template for success. For marketers, it's a narrative evolution centered on security and innovation. For the C-suite, it's about building brand resilience with purpose. And for patients, it means greater confidence that their medications will be available when needed. The phrase "Made in the USA" is evolving from a simple trust signal into a strategic competitive edge that could reshape patient care for years to come. Follow us for more insights at the intersection of pharma technology and patient impact as we continue exploring what happens after that first prescription is written.
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, the podcast exploring what happens after that first prescription. We cover the latest innovations in patient access, support, digital tools, HCP engagement, field forces and pharma marketing that we all hope drive better outcomes for patients. This podcast is for informational purposes only and does not constitute any medical advice, nor should it be used for any clinical decision-making. Patients should always consult their healthcare professionals. Welcome to the podcast. My name is Brian Carr from the Medisave team, although any opinions expressed here are exclusively my own and not those of Medisave or its partners. So what we're looking at today is accelerations in US manufacturing by pharma partners. Why this new FDA program for accelerated approvals is really mattering to pharma. You see this every decade or so or a couple of decades. As there's an inflection point, it hits the life sciences industry, one that really recasts long established assumptions around strategy, competition and investment, and the FDA's newly announced program to really streamline US domestic manufacturing construction really represents yet another such moment. As first reported by Fierce Pharma, the FDA's new, newly unveiled pilot aims to accelerate reviews for facilities that are manufacturing drugs and biologics in the United States. This timing couldn't be more critical because, with more than 20 billion already pledged for new domestic US manufacturing facilities by pharma giants, including Eli Lilly, novo Nordisk, pfizer. The government is signaling a reinvigorated commitment to reshoring critical drug production. What does it mean for pharma brand marketers, innovation teams, patient access leaders and digital transformation stakeholders? Well, it really does bring up the fact that you can reframe some of that competitive advantage from cost to control of the pipeline and the supply chain. For the past several decades it's been about cost optimization. Global outsourcing really did define pharma manufacturing strategy, but today that paradigm is in transition. You saw the COVID-19 pandemic really lay bare some of the vulnerabilities in the supply chains, not only in pharma but in other verticals, whether it's the raw ingredients sourcing in India to manufacturing sites in China. What's needed is a real resilient, agile and secure domestic US manufacturing base. It's more than a logistical initiative. It really is becoming a competitive necessity.
Speaker 0:So the FDA is what they call the Advanced Manufacturing Technologies Designation Program. What it aims to do is identify and promote the adoption of innovative manufacturing technologies, shorten the facility review timelines by up to 40%, according to FDA projections. And you may recall they had former leaders in the White House when the administration was talking about tariffs and why don't, isn't there more domestic production? And they were saying well, it takes five to 10 years to stand up a new production facility. That's why you've got FDA and EPA regulations. What was not very well reported when some of the noise around tariffs was happening was among those bullet points was the FDA and the EPA were going to streamline approvals, and that's what we're actually seeing.
Speaker 0:So brands that are going to align with this program will not only expedite time to market but also gain this narrative edge, positioning themselves as security first. Innovation led, made in the USA, for example, that's going to have a lot of credence and currency. As you see, in the coming years this is going to have a ripple effect. This type of innovation, because implications will have cross-functional teams, development will reach beyond facilities, personnel or regulatory affairs. Consider the brand marketers right. The ability to point to US-based FDA-prioritized manufacturing site could reinforce that brand integrity, especially amid patient concerns about drug shortages and recalls which they have seen. We saw that a couple of years ago with some chemotherapy medications that actually had to be rationed a bit in the US because of supply chain challenges elsewhere. Look at procurement and finance teams. What they're going to do is risk mitigation, tax incentives right, which are available for US production facilities and long-term operational savings could now be part of that new value equation Patient access and support teams.
Speaker 0:Faster production cycles paid the way for more stable inventory if it's domestically produced in the US enables consistent patient support programs, copay assistance and even formulary planning right. Ultimately, domestic capacity doesn't just promise operational margins, it unlocks institutional resilience. So what's striking here is how manufacturing it's traditionally the back office function right it now can be front and center in discussions about patient outcomes. Rel manufacturing it's not just about units on a shelf and enables consistent drug availability across geographies, predictable adherence, support and dosing regimens, improved enrollment in patient support programs because there's better logistical planning. You know a study by Acuvia found that 45% of drug shortages in 2023, I believe it was were tied to production and raw material issues. So with over half of those shortages in the US impacting chronic medication categories. So with you know, like even Medisafe, with our own Inherence Intelligent, could show a 23% or more average improvement persistence when a digital solution is used during therapy interruption. It's clear that supply integrity is integral to engagement success. So you know what about digital solutions after the script is written in this new manufacturing area? Well, what happened? You can imagine what's going to happen as more therapies are produced domestically.
Speaker 0:Digital tools are uniquely positioned, going to amplify that benefit chain for both patients and manufacturers. For example, you could have some technologies and we have it here at Medisave where you identify moments of patient invulnerability, whether it's supply gaps or dose changes, and that could cue supportive messages or HCP outreach right. If the increase in domestic capacity reduces back orders, improves fulfillment timelines, there can be adaptive messaging sent to patients earlier and often that really tilts engagement towards more confidence rather than the concern that last time I went to the doctor you know there was a shortage and I ended up not getting all the medication I needed right. Think about what happened in clinical trials, where manufacturing delays can still call, can stall enrollment or protocol updates. Tools that can really proactively align those trial timelines with patient engagement strategies can definitely reduce churn risk. So there's a lot going on there for how digital tools can actually support.
Speaker 0:But some of the key things that are going to be coming to the fore, to strategies moving forward for pharma teams and what they all pharma teams might want to do now, start doing now as this pilot moves forward for really streamlining distributions, facilities built by pharma and also R&D facilities. One is map your supply chain strategy. Understand where the key products are manufactured. Determine if domestic production is going to deliver that strategic advantage and how you would message that right. Then also integrate digital messaging. Educate parents on drug availability, delays, locally made units. Line those access teams with production. Build patient support strategies that mirror manufacturing changes. Sample kit logistics right, you have a sample kit. How can you get that more quickly to a patient right after you know, the day after they get diagnosed, in their mail of FedEx coming from Virginia or one of the distribution centers already in their doorstep? That can be an example of really key logistics that are sent and help that onboarding process. Explore the FDA's program framework for how you get to be an accelerated product right, collaborating you guys see procurement teams and IT teams really collaborating with the FDA and their regulatory commercial teams to assess eligibility for why some tracks, plants and production facilities can and should be fast-tracked under this pilot initiative.
Speaker 0:So as the industry really starts refocusing geographically, being strategically aligned digitally and operationally, it's no longer this nice to have, it's going to be essential. Manufacturing will become a differentiator. Traditionally we've seen that phrase here in the US, made in the USA. It's been a consumer trust signal. Right Now, with that FDA backing, it can really become a strategic playbook. You know FDI prioritized and made in the USA medications versus those that may be facing 200% tariffs in a few months if they're coming in from overseas. I mean that type of competitive advantage in the marketplace is going to be substantial.
Speaker 0:And then not only to onboard patients on those beds but the retention of those patients to prevent them from switching. That's where you're going to see greater enhancement spent on patient support teams and engagement. You know the doctor says for the first time the doctor is actually going to see the pricing of medications. While there may be a US domestically produced medication that you know is a certain price and some others may be higher due to tariffs or whatever. But even if it's the same price, if you've got a digital solution program and you, you know the patient knows their support team, especially for a spare, a rare or specialty med. They know Jane or Jim is my contact nurse. I tap and I can call them with any questions I have Just fantastic. I don't want to move off this medication, even if there's one that's less expensive or, you know, in some cases it may be more expensive. Why would I leave Right? So those digital support teams are really going to help where what we would say persistence and compliance, what finance people may call market share, market share preservation, right in their forecastings.
Speaker 0:So, whether it's improving the supply reliability, enriching digital enhancement or really anchoring patient trust, domestic production paired with real-time support tools can create this new template for even more success. Marketing teams, it's a narrative evolution right. Procurement, it's risk control, patient access, it's operational predictability, right For the C-suite, brand resilience, loyalty with purpose. So, as Pharma redefines where the medicines are made, it must also redefine how patients are supported and how we can keep them on path, whether it's digital solutions and others with their support teams. Thank you for joining us on Postscripts. If you found the conversation valuable, follow or subscribe for more insights at the intersection of pharma technology and patient impact. Until next time, keep looking forward. The real work begins after that script is written.
