Drug Quality in the Military Health System: CHSR 2026

George Kwiecinski attended the State of the Science: Health Services Research in the MHS symposium at Uniformed Services University on April 8-9.

This post covers only the Pharmaceutical Quality & Safety in the MHS session block from 14:45 to closing remarks at 16:00 on Day 2. A full video of the session is available upon request.

DoD Pharmaceutical Supply Chain Research: Status Update

textProf. Tracey Koehlmoos opened the pharmaceutical session with an overview of the CHSR pharmaceutical portfolio and the PhaSQ Lines of Effort (LOEs).

Slide of each LOE.

The status of each LOE as of April 9:

LOE 1 (formerly LOEs 1, 2, and 3) -- COMPLETE -- Strengthening the DoD pharmaceutical supply chain. Published in A Synthesis of Recommendations to Strengthen the Department of Defense Pharmaceutical Supply Chain, Military Medicine, 2026; 191(3–4):e578–e585. A second paper on the economic and public health burden of low-quality generic drugs is in preparation for submission.

LOE 4 -- ONGOING -- Acceptability study of the Red-Yellow-Green quality scoring tool, currently in thematic analysis.

LOE 5 -- COMPLETE -- Comparison of essential medicines lists. Published in A Comparison of the Essential Medicines Lists of the U.S. Department of Health and Human Services, the U.S. Department of Defense, the U.S. Food and Drug Administration, and the World Health Organization, Journal of the American Pharmacists Association, 2025; 65(5):102427.

LOE 6 -- ONGOING -- Independent testing by Valisure. 13 of 42 essential drug products have completed final scoring as of the conference.

Assessing the Acceptability of a Proposed Pharmaceutical Quality Scoring Tool

Ms. Miranda Janvrin, MPH

This talk took an interesting approach. Rather than presenting a finished framework, Miranda ran key informant interviews with 27 stakeholders across academia, government, and industry between October 2025 and February 2026 to test whether a new quality scoring tool was acceptable and how different groups would actually use it. Government respondents included participants from the FDA, Department of War, and VA. Interviews ran 13 to 49 minutes and were analyzed using NVivo 15.

The current quality bar for government drug purchasing is:

• FDA approved
• Manufactured at a cGMP-compliant facility
• TAA compliant (Trade Agreement Act of 1979)

The proposed framework adds a Likert-based scoring layer on top. Lower score equals higher priority. Four criteria were ranked: Product Quality, Resilience Quality, Regulatory Quality, and Location Quality.

Results: Criteria for Procurement by Position Type. Product Quality ranked first across all groups (overall 1.1). Resilience Quality second (1.5). Regulatory Quality third overall (2.0), with a notable spread: industry respondents scored it 1.4 versus government at 2.3. Location Quality ranked last (2.6), with academia as an outlier at 3.6.

Product Quality was the top priority for every single group surveyed (lowest scores mean the most important). Government was the most sensitive and cared the most about location quality, and was in the middle for regualtory and resilience.

While these are preliminary findings and additional respondents will help add clarity, a few themes emerged. Respondents across groups recognized that quality is an important procurement metric beyond price alone. Many indicated a willingness to pay more or to recommend that their institutions pay more for higher-quality products. There was also a view that adding an independent quality metric could incentivize manufacturers to compete on quality rather than just cost. The market-pressure dynamic already exists in theory among the people doing the buying. It just hasn't been formalized into procurement criteria.

Overall, this talk laid out a useful paradigm: what it would take to move drug quality from a background assumption of FDA approval into an active procurement signal, and what the people closest to that decision actually think about it.

Independent Testing and Valisure's Work

Mr. David Light, BS, Valisure

90% of the drugs Americans take are generics. That's the baseline for everything that follows.

David covered what Valisure has found in testing essential medicines under LOE-6. He opened with a recap of the first phase: 21 drugs tested, new analytical tests, individual drug highlights, and a location-based commentary on where manufacturing is concentrated.

The dissolution test problem. Each manufacturer can set their own USP monograph for dissolution testing. (1) That means Advil and Motrin can have different GMP standards for the same active ingredient, with no common benchmark to compare across them. (2) The discussion covered USP and ISO/IEC 17025:2017 accreditation, the core idea being that independent testing operates outside the standard the manufacturer used to design the test in the first place. (3)

Red doesn't mean illegal. The Red-Yellow-Green scoring framework gets misread. A red score doesn't mean a drug is violating an FDA mandate. It means independent testing flagged something worth paying attention to. Talc in medications is a good example: a potential carcinogen, analogous to nitrosamines, and a clear red under independent testing. Making it illegal overnight would create immediate shortages. A great example David used is with seat belts: while they eventually became mandated, it was market pressure and consumer choice that drove the industry to include them first. Same dynamic here.

Duloxetine showed broad issues. So broad that relative scoring doesn't work well for it. When most products in a category have a problem, relative scores flatten the signal. The absolute system shows it clearly.

No correlation between quality and price. Across the first 21 drugs tested, there is no consistent relationship between what you pay and what you get. There is some correlation with carcinogens. (4) The practical takeaway: buy the most green product at the best price. You can't do that with FDA approval status alone.

David Light presenting the GKS KeyPedia Drug Quality Intelligence Module at the CHSR 2026 State of the Science Symposium, April 9, 2026.

Citations

1. FDA Guidance: Dissolution Testing and Acceptance Criteria for Immediate-Release Solid Oral Dosage Form Drug Products

2. USP Supporting Information for Dissolution/Drug Release/Disintegration Tests (PDF)

3. Valisure: About, ISO/IEC 17025:2017 accreditation

4. Valisure FDA Citizen Petitions, ranitidine and metformin NDMA findings

Improving Resiliency in the U.S. Pharmaceutical Supply Chain

Prof. Jeromie Ballreich, Johns Hopkins

Prof. Ballreich presented remotely on make-buy-invest strategic actions for pharmaceutical supply chain resiliency. His team at JHU maintains a supply chain dashboard that maps drug sourcing by manufacturer, a useful reference for anyone working through domestic production policy questions.

Closing Thoughts

This session was uniquely important for GKS to attend. What's being built across these lines of effort is a real narrowing of the gap between what we know about drug quality and what actually informs procurement decisions. The tools are getting sharper: supply chain mapping, independent chemistry testing, scoring frameworks validated against the people who would actually use them.

Why does it matter? Because as of today, the system governing drug safety, quality, and choice is primarily price-driven. Competition is a good thing. But quality needs its own signal in that competition, and right now it largely doesn't have one. The work presented at CHSR is about closing that gap by introducing quantifiable, independently verifiable quality metrics into a procurement process that has historically operated on a binary: legal or not.

For GKS, the overlap is direct. Platforms like KeyPedia exist to bridge these data sources, independent testing results, regulatory intelligence, inspection records, and surface them in a way that teams can actually use. That's the same problem this session was working on.

If you're in pharma quality, supply chain, or regulatory, reach out or see what we're building at GKS.