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Articles

FDA specifies a patient registry and follow-up studies

A REMS Will Be Part of the Expected Launch of Anti-Epilepsy Drug From Ovation Pharmaceuticals

How recent executive orders—both under the Biden and Trump administrations—have reshaped the drug pricing landscape, and the legal challenges or uncertainties they present for pharmaceutical companies

What life sciences companies should be doing now to proactively prepare for further executive action on drug pricing and market access

The key differences in how executive policies versus legislative actions affect the pharma industry’s pricing and commercialization strategies

The legal and strategic risks executive policy shifts pose to investors and biopharma leaders who may be planning product launches or portfolio expansion over the next few years

Alice Valder Curran outlines the steps manufacturers should take to better prepare for upcoming executive actions on drug pricing and market access.

How Recent Executive Orders Impact the Drug Pricing Landscape

 interview, Claire Riches, vice president of clinical solutions at Citeline, dives into:

Specific inefficiencies in the current drug approval system that are the biggest obstacles to faster approvals

How the FDA can integrate data sources such as real-world data (RWD) to streamline approvals, while maintaining rigorous safety standards

Advancements in data collection and validation that make RWD a viable tool for drug approvals

The role payers and insurers should play in this shift toward a more data-driven, flexible approval framework, and how this could impact patient access to innovative treatments

The likelihood of bipartisan support for reforms that modernize drug approvals with shifting political priorities under HHS Secretary Robert F. Kennedy Jr.

Claire Riches highlights inefficiencies in the current drug approval process, while outlining the role of payers and insurers in shifting toward data-driven approval framework. 

Fast-Tracking the Future

 interview, Renier Brentjens, MD, PhD, deputy director and chair of medicine at the Roswell Park Comprehensive Cancer Center, discusses:

How he has seen the field evolve since its inception, and what excites him most about its future

How the Roswell Park expansion helps improve patient access to CAR T-cell therapy

The key safety concerns associated with CAR T-cell therapy, along with how Roswell Park aims to mitigate potential risks

How Roswell Park is working to make CAR T-cell therapy more widely available

The steps needed to be taken at the regulatory and healthcare policy levels in order to support the broader adoption of CAR T-cell therapy

Renier Brentjens, MD, PhD outlines the evolution of the space, while offering ways to boost patient access to these treatments. 

Embarking on the CAR-T Journey

 interview, Donald Prentiss, founder and CEO of Qualthera, explains:

The role that compounding pharmacies play in the pharmaceutical supply chain

How compounding pharmacies helped bridge the gap for patients in need of their medication (especially during the tirzepatide shortage), while dispelling the notion that commercialized and compounded drugs are competing with one another.

What he believes needs to be done amid the various legal battles pertaining to GLP-1s that are currently taking place

The inspiration behind Qualthera, along with its objectives

Donald Prentiss discusses the value of these pharmacies, especially during shortages.

A Closer Look Into the Role of Compounding Pharmacies 

The history behind the Drug Supply Chain Security Act (DSCSA)

The latest DSCSA exemptions and what that means for trading partners

How this piece of legislation and AI are able to intertwine

Nicholas Saraceno offers an overview of the legislation and how it impacts the pharma supply chain.

Nov. 27 is Here: What Does That Mean for DSCSA?

 interview, Dave DeJean, Systech’s VP of global strategic accounts, dives into:

The valuable lessons he’s learned along the way, given his three and half decades of experience at Systech

An overview of the Drug Supply Chain Security Act (DSCSA), including its three main pillars

How he would interpret this “Stabilization Period” that the FDA provided this past summer, and what he pharma industry do now during this period in order to avoid penalties later

Whether or not he anticipates the FDA implementing any other sort of delays in the near future in order to help remedy these issues/challenges surrounding the enactment of DSCSA

Podcast is available directly on SoundCloud.

Dave DeJean provides his expert insight on lessons he’s learned from his plethora of time in the industry, along with an outlook on where the pharma supply chain stands in adhering to the Drug Supply Chain Security Act (DSCSA). 

Complying With the DSCSA

In order to succeed in today’s outcomes-driven healthcare landscape, pharmaceutical companies must move from traditional sales models to strategic, measurable partnerships with integrated delivery networks (IDNs).

Bridging the Gap Between Strategy and Practice in IDN Partnerships

The designation allows pharmacists to substitute it for Humira without prescriber approval (per state law), which expands patient access in the process.

FDA Grants Interchangeability Designation to Hadlima

As this medical approach continues to become more widely adopted, the industry must adapt to help provide precise, compliant, temperature-controlled, delivery of highly individualized treatments.

How the Rise of Personalized Medicine Impacts Life Sciences’ Logistics

In a Q&A with Pharma Commerce, Kurt Lunkwitz, ProRx Pharma’s COO, uncovers the stringent requirements that 503B outsourcing facilities must abide by under the Drug Quality and Security Act, while also shedding light on the FDA’s impact when it comes to improving the safety, quality, and trust in compounded drugs.

An Exploration of Compounding Practices

In an article recently published by The New England Journal of Medicine, FDA higher-ups Vinay Prasad, MD, MPH; and Martin A. Makary, MD, MPH, wrote that any new COVID-19 vaccine must now be evaluated in placebo-controlled studies.

FDA Outlines Updated Requirement for Placebo-Controlled Trials in Vaccine Research

How MFN Executive Order Could Affect International Drug Costs

PC: Although ways to decrease healthcare costs are certainly encouraged by pharma supply chain stakeholders, what potential long-term repercussions (if any) could President Trump's MFN executive order have on the industry?

The executive order mandates that pharmaceutical companies match or beat the lowest price paid by certain countries—such as Canada, Germany, or France—or face regulatory penalties. Tying US drug prices to international benchmarks could trigger large-scale trade disputes.

Here’s what I mean: the countries whose prices would serve as the benchmark might be pressured to raise those prices, which could cause friction with trade partners and potentially violate global treaties. At the same time, reduced profits in the US market could push pharma companies to compensate by raising prices elsewhere.

Countries with universal healthcare systems or limited healthcare budgets—many of which haven't been central to the policy debate—may experience reduced access to essential medicines. Altogether, this could result in the U.S. effectively exporting its high-cost drug model, potentially leading to an unintended global affordability crisis.

Ron Lanton, Partner, Lanton Law, weighs in on the potential international trade, pricing, and access implications of tying US drug costs to those in other developed countries under the Most Favored Nation executive order.

Serialization System SOPs

Two Labs’ senior director of DSCSA/serialization compliance services

 describes how the HDA Distribution Management Conference (DMC) covers a broad spectrum of topics within the pharmaceutical supply chain, with a special focus on current regulatory and operational challenges. One of the major topics at this year’s conference was the Drug Supply Chain Security Act (DSCSA), which prompted several discussions and roundtable sessions.

The DSCSA has significant implications for the pharmaceutical supply chain, especially in terms of enhancing traceability, safety, and efficiency in drug distribution. At the DMC, various presentations and dedicated roundtable sessions were held to address its impact, compliance requirements, and the ongoing industry adaptations necessary to meet its mandates. These discussions provided insight into the challenges and solutions that stakeholders in the pharmaceutical supply chain are encountering as they work to ensure compliance with DSCSA regulations.

Overall, the DMC served as an important platform for exploring the evolving landscape of drug supply chain security, with the DSCSA at the forefront of many conversations. Given its complexity and importance, the conference highlighted the need for continued collaboration and knowledge sharing among industry professionals to navigate the regulatory landscape effectively.

Rowe also comments on where he believes industry stands in terms of DSCSA readiness; some of the supply chain disruptions that stakeholders are reporting; and much more.

What topics are at the top of the agenda for Two Labs?

I think the major dynamic that's going on in the short term is the increased engagement from FDA doing DSCSA inspections, as well as state regulators, and how they're starting to engage in DSCSA, is really giving a lot of clients pause to say, “we set up these DSCSA SOPs a couple of years ago. Have we updated them appropriately? What're the growing trends? Can we actually execute on these SOPs that we built?”

I think the biggest thing that we heard at the conference, and is resonating with a lot of our clients—as well as prospective clients—is we kind of did almost a copy-paste. Not that we have done copy-paste projects with our clients, but rather, we've had clients where we've inherited SOPs that have been kind of a copy-paste job, where it just outlines what the law is, but it doesn't really share in detail how you actually document your process, how you prove to a regulator that you're following it.

I think there're a lot of folks taking a pause and saying, “okay, we feel like we've got all the data infrastructure in place, how do we actually document what we're doing?” I think right now, the hot topic in the industry is SOPs, because as state regulators engage, as FDA engages, they're asking and they're saying, “prove to me that you can do a verification within one day. How many verifications have you been doing? Can you share a documentation with me? Is your serialization system validated?”

When you do a verification, you're using your serialization database. How do you know that that's an accurate database? I think a lot of companies are going to be going back and say, “alright, we've been in a rush-build mode. How do we maintain this?”


In the final part of his Pharma Commerce video interview, Michael Rowe, Two Labs’ senior director of DSCSA/serialization compliance services, discusses the obstacles in documenting and proving DSCSA compliance.

Is the Industry Ready for the DSCSA?

Rowe also comments on where he believes the industry stands in terms of DSCSA readiness; some of the supply chain disruptions that stakeholders are reporting; and much more.

Where do you believe the industry stands in terms of DSCSA readiness?

The mood and sentiment from the conference this year was a little bit different in that most were saying that they were exchanging data at a much higher rate. Most of the distributors and manufacturers were saying, “we're fully connected with most, if not all, of our customers, and that data is actually moving,” so the pipes have been made. Data is moving through the pipes. Generally, the sense is that—again, not a formal survey—the success rate seems to be around 90% to 95%, so it's not only that data is moving, but it's moving at a much higher quality than what we saw this time last year.

The amount of improvement has been tremendous. I think the conference was less of an implicit plea to regulators, we need more time. We're going to be pitching for this delay. I think the sentiment was, we've got the delays that we needed. We have this phased exemption period moving throughout 2025, it's how do we now deal with the upcoming deadline. A 90% to 95% success rate is good on paper. When I was in school, that would have gotten you an A or an A-minus. That sounds pretty good.

When you put that in terms of the volumes in which we're dealing with in the US pharmaceutical supply chain, on a daily basis, that could mean 10s of 1000s of product potentially getting quarantined, and so there is still concern around the speed in which exceptions can get handled and fixed. That was a big part of the conversation at the conference as well, exception handling. It has been for years. I think it will continue to be the “hot topic” in our industry. I think there's acknowledgement that we're never going to get to 100%, but when an issue comes up, how do we quickly resolve it?


In the second part of his Pharma Commerce video interview, Michael Rowe, Two Labs’ senior director of DSCSA/serialization compliance services, comments on stakeholders’ overall preparedness for complying with the latest enforcement deadlines.

Key Takeaways From the 2025 HDA Distribution Management Conference

What were your overall thoughts on this year’s HDA Distribution Management Conference?

The HDA Distribution Management Conference, or the DMC—as it's commonly referred to—is a pretty wide-ranging conference in that it covers a lot of topics in the pharmaceutical supply chain. In particular, I'll probably talk and comment more around the different conversations and roundtables that were happening around the DSCSA, or the Drug Supply Chain Security Act.

There was a whole series of presentations, and like I said, roundtables, where it was focused just on the DSCSA, given its prominence and its impact on the pharmaceutical supply chain.

Overall, the conference went well. Definitely new things that were being discussed, but also some familiar topics that we've talked a lot about in years past, so happy to dive into some of the details. I think the biggest highlight for me was more regulatory engagement from both the FDA and the state regulator side.


In the first part of his Pharma Commerce video interview, Michael Rowe, Two Labs’ senior director of DSCSA/serialization compliance services, shares his overall thoughts on this year’s DMC.

Latest Conference Coverage

Why Distractions Are Detrimental to Business

 CEO of Theratechnologies, explains how Theratechnologies' operations have been impacted by recent US tariffs on Canadian goods, especially concerning the manufacturing and supply chain for its HIV therapy, EGRIFTA SV. The active ingredients used in EGRIFTA SV come from the US, travel to Canada for additional processing, and then return to the US for final assembly. As a result, the company faces tariffs on both the raw materials and parts of the manufacturing process that cross the US-Canada border. While the tariffs will increase costs, the company benefits slightly since the tariffs are applied to raw materials and intermediate steps, rather than the fully finished product, which would have resulted in a higher cost increase.

Theratechnologies is currently assessing the full impact of these tariffs on its supply chain, including effects on insurers, governments, and patients. Despite these challenges, the company remains committed to ensuring timely delivery of its therapies to patients, managing the increased costs as best as possible.

Levesgque also comments on the forecasted obstacles regarding the availability of specialty medicines for US patients; making the decision to reshore manufacturing processes; and much more.

Note: The FDA approved the company’s supplemental Biologics License Application (sBLA) for the F8 formulation of tesamorelin for injection on March 25. The new formulation will be commercialized under the tradename EGRIFTA WR and is expected to EGRIFTA SV.

Why are distractions detrimental to business?

This creates distraction. Distraction is never good in business, especially if you drive innovation and you're focusing on bringing solutions to patients. I think the situation is uneasy, because, first of all, we're not totally sure that we have the facts to actually juggle with this issue the best possible way and find a solution.

My last thought is, there's always a payer for medicine. Sometimes it's the patient, sometimes it's the government. If governments are basically taxing medicines, that means that governments that are reimbursing medicines will pay a higher price. That is bound to be an issue. The US government has an Inflation Reduction Act in place so that we cannot increase the prices of medicines for the medicines they are imbursed. They want to control cost.

Well, governments in Canada and elsewhere have the same type of approach, so that is really opening up a potential can of worms that could create a lot of grief. How it will settle, I don't know, but I think that the people that are putting in place these changes now have not assessed that properly, and it will have repercussions. As I said before, I think the pharma industry will be nimble again, will stay focused, and will try to identify solutions. There are potential solutions, but as I said, most of them cannot be implemented on a dime. It's a significant disruption in the way we operate, especially for two countries that are so intertwined in all they do, as Canada and the US are.

In the final part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Paul Levesque, CEO of Theratechnologies, describes the uneasiness behind regulatory complications. 

Analyzing Tariffs’ Effect on the Biopharmaceutical Supply Chain

How have the recent US tariffs on Canadian goods impacted Theratechnologies' operations, particularly in terms of cost and supply chain management for your HIV therapies in the US market?

We will be affected by that, because the different ingredients that actually get into the making of EGRIFTA SV comes from the US, and comes to Canada for additional progress in the manufacturing. Then, it crosses the border again back to the US. Any company is going to have to do a very tight assessment of supply chain—which we have done—and currently, the active ingredient comes from the US, crosses the border in Canada, and will be taxed on the value of that active ingredient.

Then, there's part of the manufacturing process that is being done in Canada. When it will cross the border to the US, it will be taxed again on the value of that part of the manufacturing process, and the final assembly is done in the US.

In our case, there will be tariffs affecting the cost of manufacturing. Fortunately, it will be done on the value of what's crossing the border. Since this is raw material the first time and only another step in the production the second time, the value is not as high as the finished product, because if the finished product is $100 and you have tariffs of 25%, that tells you how much of an increase it will be.

In our case, there will be an increase. We'll try to manage that the best possible way. We're not done with assessing the impact of that for insurers, for governments, and for patients, but we are committed to making sure that our drugs will get to patients on time, every time, as they should.

In the first part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Paul Levesque, CEO of Theratechnologies, outlines how US tariffs on Canadian goods have impacted the company’s operations, particularly in terms of cost and supply chain management in the US market.

Preparing for DSCSA Deadlines 

, Jody Hatcher, CEO of Morris & Dickson and chair of HDA’s board of directors

 outlines his vision for the future of the organization and the key priorities he hopes to drive during his tenure. He expresses a strong sense of privilege and responsibility in succeeding Kirk Kaminsky and looks forward to collaborating closely with Debbie Weitzman of Cardinal Health to strengthen connections across the pharmaceutical supply chain.

Hatcher emphasizes the often-overlooked value that distributors bring to the healthcare ecosystem. Representing more than 1,200 manufacturers and serving around 330,000 pharmacies and care providers, he describes distributors as being part of an "irreplaceable network" that plays a vital, behind-the-scenes role in ensuring the availability of medications and healthcare products across the country.

He outlines three main priorities for his leadership. First, he aims to enhance engagement within the distribution community—bringing together pharmacies, manufacturers, and distributors around their shared mission. Second, he highlights the critical importance of implementing the Drug Supply Chain Security Act (DSCSA) across the supply chain. With an extension recently granted, Hatcher underscores the need to meet the updated deadlines to maintain the reliability and integrity of the distribution network.

Lastly, he stresses the importance of storytelling—articulating the value and sophistication of the distribution sector to external audiences. He notes that while distributors are often discussed in various contexts, it's essential to clearly communicate their indispensable role in maintaining a secure and efficient healthcare supply chain.

Overall, Hatcher's vision centers on strengthening collaboration, ensuring compliance, and raising awareness of the distribution sector’s critical contributions.

Hatcher also comments on his day-to-day workflow at Morris & Dickson, including how it supports the efficiency and reliability of the company’s operations; steps that should be taken to ensure DSCSA compliance; types of implications that the potential 25% tariffs on pharmaceuticals can cause; and much more.

With the DSCSA implementation deadlines for pharma supply chain stakeholders fast approaching, what steps should be taken to ensure compliance? Are there any technological or operational adjustments that can help?

DSCSA is a mission-critical priority for every member of HDA. We've had work groups that have had daily and weekly meetings around the HDA table, and HDA has been working deliberately with the FDA on the traceability issues for probably two decades.

At the end of the day, DSCSA fundamentally means that we want to ensure the safe and effective implementation for our customers and for the products that they buy from us. Obviously, the most critical deadline is May 27, when pharmaceutical manufacturers and the repackagers need to meet the criteria in terms of the data at the package level, or have their waivers or exemptions in place, so it's important. It's an important indicator of readiness, not only for the manufacturers, but also for distributors and dispensers, and then for the distributors, for all of us, by Aug. 27, 2025, we've got to be able to receive and trace product from the manufacturers and provide data to our dispensers. We've got to receive and provide EPCIS data at the product unit level. This requires review of processes, such as the practices for returns—which is complicated—product quarantines, testing, and communication.

At the end of the day, I think the message here for all constituents is this has to be a priority, and it involves the technology you've deployed, it involves your systems. I think for all of us, it's really just a shift in the way we work. Our intent, our aim here at Morrison & Dixon, and I think with the rest of HDA, is to make sure that DSCSA is fully integrated into what we do. It's just not optional. And again, I'd like to hope that everybody involved with implementation feels the exact same way.

In the third part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Jody Hatcher, CEO of Morris & Dickson and chair of HDA’s board of directors, comments on the steps needed to achieve Drug Supply Chain Security Act compliance.

The Complexity of Healthcare Price Transparency

Turquoise Health’s SVP of market solutions

 describes how the recent executive order on healthcare price transparency aims to make pricing in the healthcare industry more accessible and understandable for patients. This initiative is a continuation of efforts by both the Trump and Biden administrations, with the goal of improving transparency around hospital and payer reimbursement rates. The central idea is to require all hospitals and insurance companies to publicly disclose their contractual reimbursement rates, meaning patients will have clearer insights into what insurers pay hospitals for services.

Historically, these prices were not transparent, making it difficult for patients to understand the actual costs of healthcare. While earlier laws introduced in 2019 improved pricing transparency, there have been enforcement challenges. The new executive order seeks to address these issues by ensuring hospitals and payers comply with transparency requirements. A key update in the order is the inclusion of prescription drug prices, which had previously been excluded from transparency rules.

The broader impact of this order is to make healthcare pricing as transparent and predictable as other consumer services, like booking a flight or a haircut. Although the system is not fully realized yet, this executive order lays the foundation for a future where patients can easily access upfront pricing before seeking healthcare services. This transparency is expected to simplify the decision-making process for patients, ultimately fostering a more informed and competitive healthcare environment.

O’Dell also comments on the biggest challenges healthcare organizations currently face in terms of price transparency; where the healthcare industry currently stand in terms of compliance with price transparency regulations; specific strategies Turquoise Health provides in order to help healthcare providers navigate and meet the new price transparency requirements; and much more.

What are the biggest challenges healthcare organizations currently face in terms of price transparency?

The biggest challenges I think healthcare organizations and payers face is just that the data that's required to be published is absolutely massive. The company I work for, Turquoise Health, is a price transparency company. We ingest a petabyte of data every single month, which is a massive amount of data to bring in. That means we're going out to 11,000 different sources and grabbing it from all the payers and all the hospitals, and trying to bring all that data in and standardize it. I think just the size is a very difficult part.

Perhaps even more important than that is the word that I just said, which is “standards.” In order for it to be useful, everyone's got to do it in the exact same way. It's kind of like, everyone's got to drive on the same railroad track size if you want the trains to be able to integrate and go across state lines. Same is true for these data flows. We're getting there, but we're not quite there yet, meaning that hospitals’ contracts are highly variable, so the way one hospital might contract for a service is very different, compared how the next one does. When they publish the data, now you have to find a way to make it apples to apples so that a consumer can compare. That is the absolute hardest part of price transparency—they can show you the price, but you as a consumer might not know what to make of that unless someone standardizes it.

In the second part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Chris O’Dell, Turquoise Health’s SVP of market solutions, discusses the biggest challenges healthcare organizations currently face in terms of price transparency.

Breaking Down the New Executive Order on Healthcare Price Transparency

Can you explain the key provisions of the recently released executive order on healthcare price transparency and how it will impact the healthcare industry?

These executive orders are about price transparency, and this is not a new concept for the Trump administration or for the Biden administration for that matter. This happens to be one of the few bipartisan things perhaps that's out there. In essence, what they want to do is make all hospitals and all payers make all of their contractual reimbursement rates public. Those are complicated terms if you're not in the industry, but it basically just means, what is your insurer, as a patient, pay to the hospital for the service that you received? As wild as this sounds, until these price transparency laws were out, none of that ever existed.

That was all a guessing game, and no one had any visibility into it. Over the course of the last four years, since the first version of these laws came out in 2019, we've seen a lot better prices, and we've seen a lot better data on these—what does the payer pay to the hospital?

Why are we talking today? Why does this new executive order even need to happen? It's because first they feel that the laws have not been enforced enough. They're saying, these are good laws, but we need to really make sure that hospitals and payers are doing this, and we're going to enforce it if they're not doing it. The second thing that comes through is drug prices. Hospitals and insurance companies had to make all their rates available, but somehow, the pharmacy benefit drugs, or prescription drugs—as they reference in this executive order—squeaked away and didn't have to comply with the regulations.

They're coming back and saying, we're going to enforce and we're going to make sure that drug prices are visible. What does this mean for the whole healthcare industry? I actually agree with what I think the government believes here, which is that it makes it easier for a patient to understand what they're going to pay for healthcare services before they go in. They use this term of “guaranteed upfront prices,” and that's their government speak for saying it's as easy to go get healthcare services and know what you're going to pay as it is to book a flight or go get a haircut or whatever example you want to use—that's what they're going for. We are not there yet, but these are the building blocks and foundation that they're using to get there.

In the first part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Chris O’Dell, Turquoise Health’s SVP of market solutions, outlines the key provisions of the recently released executive order on healthcare price transparency.

Pharma’s Response to the Biosecure Act

In the final part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Brad Stewart, BDO’s national life sciences co-leader, details the Biosecure Act, including the ways pharma companies are preparing for it, especially from a compliance standpoint.

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