. He can be reached at nsaraceno@mjhlifesciences.com.

Nicholas Saraceno, Editor

Peer Exchange: Building the Next Generation Supply Chain Talent Pipeline (Episode 9)

 roundtable discussion, Nicholas Saraceno, editor of 

 and the peer exchange’s moderator, introduced a discussion on the pharmaceutical supply chain, highlighting its complexity and importance in delivering medications safely and efficiently from manufacturers to patients. The conversation explored the roles of various stakeholders, the need for supply chain resilience and quality control, and the growing importance of data management in achieving these goals.

The pharmaceutical supply chain is a multi-stage system encompassing: research & development; manufacturing; distribution: pharmacies and healthcare providers; and patients.

This system plays a vital role in supporting both individual and public health. It ensures patient safety by maintaining drug quality, authenticity, and regulatory compliance. Additionally, it supports public health by providing consistent access to essential medications and vaccines. During times of crisis—such as pandemics, natural disasters, or supply disruptions—the supply chain becomes even more critical for delivering life-saving therapies and maintaining stability. Efficient supply chain logistics also contribute to cost control,

helping reduce healthcare spending and improve the affordability of medications.

Ultimately, a resilient, transparent, and well-managed pharmaceutical supply chain is foundational to maintaining global healthcare systems. It ensures that patients receive the medications they need when they need them, and that providers and manufacturers can work collaboratively to meet evolving challenges in healthcare delivery.

The panel consisted of Dave Malenfant, an expert that specializes in optimizing the supply chain through innovative solutions for people, processes, and technology; Opeyemi Odusami, a seasoned professional with over 12+ years of experience and 10+ years at Sanofi; and Bob Celeste, Founder, Center for Supply Chain Studies, and Executive Director, Open Credentialing Initiative (OCI).

Each expert brought distinctive perspectives on the value of the pharmaceutical supply chain, including techniques for resilience.

Malenfant highlighted offers a holistic, circular model defined by seven stages: plan, source, make, deliver, sell, sustain, and return. This perspective emphasizes the importance of viewing the supply chain as an interconnected system, where resiliency depends on maintaining strong links across all stages. Each segment can have its own strategy, but the key is ensuring smooth, uninterrupted flow of both materials and data from end to end. Disruptions—such as current hospital drug shortages—often reflect failures at earlier stages, like sourcing or manufacturing. For instance, many shortages stem from the inability to obtain active pharmaceutical ingredients (APIs), which then ripple down the chain. He encouraged the audience to think of resiliency not just as a concept, but as an ongoing process of identifying weak links and implementing strategies to strengthen them, thereby ensuring the continuity and stability of the entire supply network.

Odusami added that supply chain resiliency involves not only responding to crises but also anticipating and preventing them. In addition to maintaining a synchronized supply chain—from purchasing and manufacturing to logistics and distribution—companies must build adaptability into their systems. This means being prepared for disruptions while also using data and planning to predict future issues. A resilient supply chain ensures continuity in drug delivery to patients, even during crises. Aligning all parts of the supply chain is key to maintaining consistent access to medications and protecting public health in the face of unexpected challenges or shortages.

As for Celeste, he noted that as more regions like the United States and Europe adopt product serialization, data and product misalignment has become a growing challenge in the pharmaceutical supply chain. In the US, such mismatches often result in products being placed in quarantine, with limited time and space to resolve the issue before the product is returned or removed. A key aspect of supply chain resiliency is the ability to efficiently manage these exceptions to avoid disruptions. Since serialization errors can escalate quickly, developing systems to handle data alignment and resolve issues promptly is critical to keeping products moving through the supply chain.

The panel also dove into risk mitigation; the handling of drug shortages, and crisis management; ensuring product quality across global manufacturing sites; dealing with counterfeit products; the Drug Supply Chain Security Act (DSCSA); the importance of a developing a deep talent pipeline; sustainable practices; and much more.

Videos

In the ninth part of this roundtable discussion, industry experts discuss how the pharma supply chain is evolving into an integrated business planning function, highlighting the need for diverse skill sets, digital dexterity, and AI-enabled capabilities to prepare Gen Z and future leaders for patient-centric problem solving.

Peer Exchange: Building the Next-Generation Supply Chain Talent Pipeline (Episode 9)

Image Credit: Adobe Stock Images/ImagingL.com

Following an eight-day bench trial, a judge has issued a final judgement ruling that pharmacy benefits manager Caremark—a subsidiary of CVS Health—must pay $289.9 million in damages to Sarah Behnke, in a False Claims Act whistleblower case.

In June, the court had originally ruled that the PBM had encouraged insurers—including Behnke’s former employer, Aetna—to submit inflated drug claims to the federal government that dated back to 2010.

Allegations of underpayment to pharmacies

Behnke also had claimed that Caremark was underpaying pharmacies such as Walgreens and Rite Aid for medications. She had originally filed the lawsuit in 2014, several years before CVS Health had even completed its acquisition of Aetna in 2018.

The initial damages during the June ruling had been set at $95 million, but those have since tripled, with the breakdown being:

Fraudulent Medicare claims undermine public trust

In other words, the defendants were liable for false and inflated drug prices that had been reported to the government for prescriptions filled for Medicare Part D beneficiaries, resulting in the federal government overpaying these generics.

According to the court, the $4.8 million represents a per-claim penalty "near the top of the statutory range" of $5,500 to $11,000, given the fact that "Caremark's misconduct was serious." CVS had claimed that Behnke’s allegations were not fully supported, arguing that the original $95 million penalty was sufficient. Despite the argument, Judge Mitchell Goldberg felt that fraudulent Medicare claims were going to undermine public trust in the Centers for Medicare & Medicaid Services (CMS).

"This is a terrific outcome for our client and the US government and taxpayers," said Executive Shareholder David F. Sorensen, who led Berger Montague's trial team, the led law firm representing Behnke.

The court found that the Caremark defendants were liable for false and inflated drug prices that had been reported to the government for prescriptions filled for Medicare Part D beneficiaries at two national chain pharmacies (Walgreens and Rite Aid), causing the federal government to overpay for these generic drugs.

The CVS Caremark whistleblower case dates back to 2014, four years before CVS acquired Aetna.

Damages originally set at $95 million were tripled to nearly

Fraudulent Medicare claims were found to erode public trust in CMS oversight of taxpayer-funded drug benefits.

Broader legal battles in the pharma industry

The latest ruling is among a flurry of legal battles taking place within the pharma industry. Recently, Texas filed a lawsuit

 against Eli Lilly over bribery allegations, claiming that Lilly used various practices to illegally induce medical providers in the state to prescribe Lilly’s products instead of its competitors. The complaint called out two programs that Lilly provided for HCPs: a free nurses program and reimbursement support service.

“Big Pharma compromised medical decision-making by engaging in an illegal kickback scheme,” said Texas State Attorney General Ken Paxton. “Eli Lilly fraudulently sought to maximize profits at taxpayer expense and put corporate greed over people’s health. I will not stand by while corporations unlawfully manipulate our healthcare system to line their own pockets.”

Separately, GSK has reached an mRNA patent settlement

 with BioNTech, CureVac, and Pfizer, ending US litigation over COVID-19 and influenza vaccines. The deal reduces GSK’s future royalty obligations on its mRNA programs and could pave the way for a global resolution following BioNTech’s planned CureVac acquisition. No liability was admitted by any party.

Among the main settlement terms, BioNTech will pay GSK $370 million upfront and 1% royalties on US sales of licensed products from Jan. 1, 2025, along with $130 million and 1% royalties on rest-of-world sales following the closing of the deal.

Meanwhile, CureVac will receive $370 million at closing, along with $50 million from GSK for monetizing a portion of US product royalties due under its existing license agreement.

1. Pharmacy Benefits Manager Caremark Must Pay $290 Million After Trebled Damages and Assessed False Claims Act Penalties. PR Newswire. August 21, 2025. Accessed August 22, 2025. 

https://www.prnewswire.com/news-releases/pharmacy-benefits-manager-caremark-must-pay-290-million-after-trebled-damages-and-assessed-false-claims-act-penalties-302535821.html

2. Pennsylvania judge hits CVS with $289M fine in whistleblower suit. 

. August 21, 2025. Accessed August 22, 2025. 

https://www.fiercehealthcare.com/payers/pennsylvania-judge-hits-cvs-289m-fine-whistleblower-suit

3. Hollan M. Texas Sues Eli Lilly for Allegedly Bribing Providers to Prescribe Drugs. 

. August 13, 2025. Accessed August 22, 2025. 

https://www.pharmexec.com/view/texas-sues-eli-lilly-allegedly-bribing-providers-prescribe-drugs

4. Tracy D. GSK Gains $370 Million Upfront, Reduced Royalties in CureVac mRNA Patent Settlement Agreement with Pfizer, BioNTech. 

. August 8, 2025. Accessed August 22, 2025. 

https://www.pharmexec.com/view/gsk-gains-370-million-upfront-reduced-royalties-curevac-mrna-patent-settlement-agreement-pfizer-biontech

Articles

A federal judge tripled damages against the pharmacy benefits manager after finding it encouraged inflated Medicare drug claims and underpaid pharmacies.

CVS Caremark Ordered to Pay $290 Million in False Claims Act Whistleblower Case

 podcast where we bring you the latest insights shaping patient access, supply chain/logistics, data & tech, and healthcare innovation. I’m your host, and today we’re covering updates on international trade, a US manufacturing investment, and new federal rules shaping electronic health records.

The White House and European Union have agreed on a 

 that includes tariffs on pharmaceuticals and precursors. Per the deal, US imports from the EU will be subject to either the most-favored-nation rate or a 15% duty—whichever is higher. The move is expected to impact generics, APIs, and chemical inputs, with industry leaders warning of potential cost increases that could ripple through global supply chains.

In other news, Johnson & Johnson has announced a 

to expand its pharmaceutical manufacturing campus in North Carolina. The project will add significant capacity for biologics and sterile injectables while creating hundreds of new jobs. J&J says the expansion is part of its long-term strategy to strengthen US-based manufacturing and ensure supply resilience for critical therapies. The investment underscores the growing trend of reshoring pharmaceutical production in response to both policy and supply chain pressures.

Lastly, in health IT, the federal government has issued a 

 requiring electronic prescribing and prior authorization capabilities to be integrated into certified electronic health record systems. The goal is to reduce administrative burdens, improve prescribing accuracy, and streamline prior authorization processes for providers. By embedding these functions directly into EHR platforms, regulators hope to cut down on delays in patient access to medications and reduce friction between payers, prescribers, and pharmacies.

From shifting global trade rules to major domestic investment and regulatory updates in health IT, these stories highlight how policy, infrastructure, and technology continue to reshape the pharmaceutical landscape.

. For more insights on trends transforming pharmaceutical access and care delivery, visit 

Thanks for listening—until next time, stay well and stay informed.

Podcasts

This episode of Pharma Pulse covers the White House–EU agreement on pharmaceutical tariffs, Johnson & Johnson’s $2 billion expansion of its North Carolina manufacturing site, and a new federal rule requiring e-prescribing and prior authorization tools in certified EHR systems.

Pharma Pulse: Pharma Tariffs Take Shape, J&J Invests $2 Billion in US Manufacturing, and New EHR Rule Targets Prior Authorization

Image Credit: Adobe Stock Images/Aquir.com

 the White House and European Union today revealed a framework for a deal centered around “reciprocal, fair, and balanced trade” that is expected to get into effect Sept. 1 of this year. Although the agreement covers all imported goods coming from the EU, pharmaceuticals fall under a distinct set of regulations.

The United States will be applying the higher of either the most-favored nation (MFN) tariff rate or a duty of 15%, so basically, tariffs will not be higher than the aforementioned 15%. This includes generic pharmaceuticals, their ingredients, and chemical precursors, stemming from President Trump previous July announcement from President Trump reaching a formal trade agreement with the EU in which a maximum 15% levy would be imposed on “most” EU exports, including autos and their parts; semiconductors; and pharmaceuticals.

 The EU will also be investing $600 billion in the US and purchasing $750 billion worth of US energy exports through the year 2028.

Shifting tariff proposals earlier this year

The development comes amid the multitude of changes that have transpired over the course of six months beginning in early February, when President Trump announced that the US planned to approve a tariff of 25% or higher on pharmaceuticals.

 That number then skyrocketed to as high as 250%—a new high—which Trump had revealed in an interview with CNBC’s “Squawk Box.”

The new US-EU trade deal caps pharmaceutical tariffs at 15%, despite earlier proposals as high as 250%.

The agreement includes a commitment from the EU to invest $600 billion in the U.S. and purchase $750 billion in US energy exports through 2028.

Experts note that tariffs on APIs would have minimal impact, but tariffs on finished drugs or key components like glass and bottle plugs could significantly raise costs.

Potential impact on the pharma supply chain

, Dave Malenfant, a healthcare supply chain expert, discusses the potential impact of a proposed 250% tariff on pharmaceutical imports, emphasizing that the effect depends heavily on where in the supply chain the tariff is applied. If imposed on active pharmaceutical ingredients (APIs), the impact would be minimal, as APIs contribute relatively little to the total cost of a finished drug and adjustments could be made through negotiation.

However, if applied to finished pharmaceuticals or key components—such as bottle plugs, closures, molded parts, and glass—the cost implications could be significant, since these materials represent a substantial portion of overall manufacturing costs.

“It depends where the tariff is applied. If you're talking about the active pharmaceutical ingredients, they'll have very minimal impact, as you get into the royalties and all that,” he explained. “When you look at the cost of a pharmaceutical product, a lot of the cost is not in the active ingredient, as much as the components to package it in the processing. If we are buying a finished pharmaceutical and it's got a 250% tariff on it, and the proposed regulation says that there will not be a duty drawback, because right now, on a lot of pharmaceuticals, you have duty drawback, which means you pay duty upfront, and then you can go and apply to the government and draw back.

"What that does is it will have a direct impact throughout the entire supply chain, but at the same time, it's telling the US, why aren't we making these pharmaceuticals in the United States? Most of the research and development has been done in the United States, but then we export it out to cheaper countries to make the product, and they import it back in, such as Singapore—I’m not going to talk about India, because India is a unique situation—or other countries, and then we import it back in trying to distribute it within the United States. … I think if we're going to sell in United States, I firmly believe that we should make it in United States.

1. Hollan M. White House and European Union Announce Long-Awaited Details on Pharma Tariffs. 

. August 21, 2025. Accessed August 21, 2025. 

https://www.pharmexec.com/view/white-house-european-union-details-pharma-tariffs

2. Saraceno N. As Trump Pharma Tariff Deadline Looms, Here's How the Sector Got Here. 

. July 31, 2025. Accessed August 21, 2025. 

https://www.pharmaceuticalcommerce.com/view/trump-pharma-tariff-deadline-looms-how-sector-got-here

3. Saraceno N. Trump: Tariffs Could Potentially Hit 250%. 

. August 7, 2025. Accessed August 21, 2025. 

https://www.pharmaceuticalcommerce.com/view/trump-tariffs-could-potentially-hit-250

The new framework, set to take effect September 1, limits tariffs on pharmaceutical imports to 15% but follows months of shifting proposals, including threats of tariffs as high as 250%.