Pentagon Taps Independent Lab, Not FDA, to Test Safety of Generic Drugs for Service Members

The Pentagon in Washington on Jan. 26, 2020. Pablo Martinez Monsivais/ AP Photo

The U.S. Department of Defense is contracting with independent drug testing firm Valisure to help ensure the safety of generic medications given to service members and veterans.

The small Connecticut lab has repeatedly detected harmful substances in widely used drugs in recent years.

In an announcement on Tuesday, Valisure said it had signed a contract with the Pentagon to create a program to test the quality and safety of generic drugs distributed throughout the U.S. military. The contract stems from a mandate in this fiscal year’s military budget bill to assess risks to the Pentagon’s pharmaceutical supply chain.

“By creating much-needed transparency in drug quality, this program will enable conscientious manufacturers to be able to better compete and allow major purchasers of drugs like the DoD and Department of Veterans Affairs to reward good manufacturers and exclude substandard medicines from being consumed,” the company said.

While a task like this is usually given to the U.S. Food and Drug Administration (FDA), it’s becoming increasingly difficult for the agency to monitor the quality of generic drugs, since the production and ingredients needed to make them have been mostly moved to India and China, where the FDA has limited regulatory and oversight power.

Independent Analysis and Transparency

In 2020, when FDA inspections of foreign plants were frozen with COVID-19 restrictions, Valisure chief executive David Light testified before the Senate Finance Committee, suggesting independent laboratory testing as a prerequisite for all foreign-manufactured drugs to be sold in the United States.

“Independent, proactive chemical analysis of medications that is made transparent to all in the health care ecosystem is critical, and not just for generic manufacturers in a handful of overseas countries, but as an overall industry standard,” Mr. Light said.

Based in New Haven, Connecticut, Valisure routinely conducted chemical analysis of drugs and products sold at an online pharmacy it used to operate. The company sold its online pharmacy business, called ValisureRX, in 2021, to concentrate only on quality and safety testing.

Over the past few years, Valisure drew much attention by testing common consumer products and medications and uncovering safety problems that federal regulators and manufacturers had overlooked.

Their testing has led to several high-profile recalls. In 2019, Valisure detected high levels of a cancer-causing carcinogen in the heartburn and acid reflux drug ranitidine and its brand name version, Zantac, causing the FDA to recall all over-the-counter ranitidine drugs from the market.

Another massive recall came last year, when Valisure found benzene, also carcinogenic, in hand sanitizers and spray sunscreens, as well as some of the top-selling dry shampoo products.

Valisure Investigated

Last year also saw the company itself having become the subject of a now-resolved investigation by the FDA. According to Consumer Reports, shortly after Valisure published the hand sanitizer testing results, the FDA spent several weeks inspecting the lab’s facilities before accusing it of operating without proper regulatory approvals.

In December 2022, the FDA sent a letter to Valisure, saying that the company failed to meet drug supply chain security requirements while it still owned ValisureRX. FDA officials also said they found instances where the pharmacy department failed to investigate suspect products, failed to identify illegitimate products, and failed to notify the FDA it received an illegitimate product in a timely manner.

The letter (pdf) acknowledges Valisure doesn’t run a pharmacy division anymore and had already stopped selling drugs at the time of the inspection. The FDA nonetheless warned Valisure it must get familiar with aspects of federal regulation for drug sellers if it ever goes back into the pharmacy business.

Among Valisure’s advocates is Rep. Rosa DeLauro (D-Conn.), who argued that the FDA should focus the safety of drug and health care products instead of going after the private testing company.

“Valisure’s work has raised the alarm on both the quality and safety of drugs and personal care products for millions of consumers and their families. Instead of this ongoing hostility, FDA should embrace their efforts in the pursuit of safeguarding the public’s health.” Ms. DeLauro told Consumer Reports.