Williams: Taxpayers deserve better than wasteful defense contracts

David Williams

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As taxpayers are painfully aware, government contracts can easily go awry. Federal taxpayers paid Boeing an astounding $3.9 billion to build two Air Force One aircraft; costs have ballooned with taxpayers on the line for ancillary costs. 

Now, the Department of Defense is doubling down on fiscal misfeasance by hiring a discredited company to safety-test drugs that have already been approved by the Food and Drug Administration. Given that the Pentagon can’t stop failing its annual financial audits, these bank-breaking contracts are terrible news for taxpayers. The Pentagon must stop squandering money and give taxpayers a break on opaque contracts.

In August 2023, the Defense Department announced that it had inked a “Cooperative Research and Development Agreement” with a company called Valisure to “generate objective drug quality data through independent sourcing and testing for metrics that are expected to differentiate the quality of available manufacturers of a given list of drugs.” 

Never mind that the FDA monitors drug quality, coordinates recalls, keeps an eye out for contaminated medicines and maintains stringent import controls.

Between taxes and user fees, the agency rakes in about $7 billion yearly to do its job. Given the FDA’s excessive risk aversion and meddling in drug development, the agency could probably take its foot off the gas and do its job on a leaner budget. However, given the agency’s overzealous enforcement, it makes little sense to duplicate already robust FDA efforts. 

It makes even less sense to entrust this effort to Valisure. In December 2022, the FDA sent the company a letter pointing out that its online pharmacy didn’t take the time to investigate suspect or illegitimate products and strayed from FDA reporting requirements. The agency further pointed out that Valisure “failed to establish and document the accuracy, sensitivity, specificity and reproducibility of its test methods.” 

While the company was using FDA testing techniques such as the Gas Chromatography-Mass Spectrometry method and the Liquid Chromatography High Resolution Mass Spectrometry methods to detect product abnormalities, the FDA found that the company was serially misapplying these methods and coming to faulty conclusions. In addition, Valisure failed to “provide sufficient evidence that (testing) equipment was qualified for its intended purpose and could robustly perform the required operations.” 

In science, “trust me bro” is no substitute for rigorous research and documentation. The Taxpayers Protection Alliance Foundation has sent multiple Freedom of Information Act requests to Defense and the FDA to get to the bottom of this botched testing, but it has yet to hear back. 

Yet, Defense insists that taxpayers and consumers trust Valisure to vouch for medications already approved by the FDA. In its press release announcing the contract, the department cites statutory requirements in the National Defense Authorization Act, which instructs the Pentagon to “assess risks to the Department’s pharmaceutical supply chain.” 

However, the Pentagon doesn’t need to reinvent the wheel to deliver on Congress’ mandate. Defense officials could comply with the NDAA language by paying close attention to FDA recalls and the latest agency warning letters sent to suspect suppliers. It could also prioritize drug brands that have ample supply and manufacturing capacity. The department needn’t rely on a contractor with a spotty testing record to double-check a federal agency’s findings. 

If Congress wants to bolster the safety and availability of drugs for consumers, focusing on FDA reform would be a far more promising route than vague NDAA language. As the Taxpayers Protection Alliance notes in a 2023 report on FDA reform, the agency is failing to use all the empirical data (e.g., studies using historical data) to evaluate medications. Lawmakers can push the FDA toward considering all the evidence and creating a more holistic approval process. This is far better than bilking taxpayers for costly and unnecessary contracts.

Editor’s note: David Williams is the president of the Taxpayers Protection Alliance. He wrote this for InsideSources.com. Reader reactions, pro or con, are welcomed at AzOpinions@iniusa.org.