Pentagon Asks Valisure, Not FDA, to Make Sure Drugs for Servicemembers are Safe

The Defense Department is reportedly seeking Valisure’s help in ensuring generic drugs, often manufactured overseas and away from FDA influence, given to military service members are safe and effective

The U.S. Department of Defense has asked the independent drug testing firm Valisure to help make sure generic medications given to servicemembers are safe, after the on-line pharmacy’s methods have identified a number of contaminants and cancer-causing chemicals in widely used drugs in recent years, before they were detected by federal regulators.

According to a Bloomberg News report published last week, Valisure will create a program to test the quality and safety of drugs commonly distributed to service members throughout the military. Neither the Department of Defense nor Valisure has confirmed the arrangement.

Valisure is based in New Haven, Connecticut, and used to operate an on-line pharmacy along with its independent laboratory, which routinely conducted chemical analysis of drugs and products sold their inventory. The company sold its ValisureRx division in April 2021.

Since 2018, Valisure testing has resulted in massive Zantac recalls, metformin recalls, sunscreen recalls, spray deodorant recalls and dry shampoo recalls, after products were found to contain unsafe levels of carcinogenic chemicals, which were not discovered by the manufacturers or the FDA.

This new report indicates that drug shortages, many of which developed during the COVID-19 pandemic, are mostly caused by quality issues, as well as supply chain problems. Defense officials indicate the problem is serious enough to qualify as a national security threat, according to Bloomberg, leading the Pentagon to engage Valisure for independent testing.

While such a job usually falls to the U.S. Food and Drug Administration (FDA), it is difficult for the agency to monitor the quality of generic drugs, which are often manufactured in India and China, where the FDA has limited regulatory and oversight power.

Last month, Bloomberg reported that the White House assembled a task force to address drug safety and the impacts on the U.S. drug supply at the beginning of the year. The task force was reportedly expected to finalize some proposals to address the issue by early spring, but has missed that deadline.

Valisure’s Testing Routinely Lead to Massive Recalls

Valisure first gained national attention in September 2019, when its finding led to the discovery that all versions of the heartburn drug Zantac contained levels of the cancer-causing chemical N-nitrosodimethylamine (NDMA), at levels that exceeded 26,000 times the amounts allowed by the FDA.

This resulted in Zantac being pulled from the market, and was the catalyst for thousands of Zantac lawsuits being filed by former users diagnosed with bladder cancer, esophageal cancer, liver cancer, pancreatic cancer, stomach cancer and other injuries as the toxic chemicals passed through their bodies.

Independent investigations by Valisure have also resulted in the identification of NDMA in a variety of other generic drugs, often involving the creation of the toxic chemical as a byproduct of changes to the generic drug manufacturing processes, which the FDA failed to discovery.

In May 2021, Valisure issued a press release warning about high levels of benzene in dozens of spray sunscreen sold by several different companies, including Neutrogena, Aveeno, Coppertone, Banana Boat, CVS After-Sun and other sunscreen products. The warning cautioned consumers that exposure to the toxic benzene chemical could increase the risk of several forms of cancer. As a result of the findings several sunscreen cancer lawsuits have been filed in recent months against Johnson & Johnson, Coppertone and other.

In October 2021, Johnson & Johnson and Costco announced they had reached a sunscreen lawsuit settlement agreement to resolve multiple cases, and Johnson & Johnson subsequently agreed to pay a full refund for the price of purchasing the recalled spray sunscreen products to class members, and $1.75 million in vouchers for consumers who purchased benzene-tainted products which were not subjected to the recall.

Another report issued by Valisure surfaced in November 2021, indicating the pharmacy had identified high levels of benzene in numerous brands and batches of body spray and deodorant spray products, including Old Spice, Secret, Suave, Tag and others.

Valisure noted that some inactive ingredients commonly used in body sprays in particular, such as butane, isobutane, propane and alcohol, could be potential sources of benzene contamination. Similar circumstances may have played a role in the level of benzene detected in sunscreen spray-on products.

Following the report, an Old Spice and Secret deodorant recall was issued by Proctor & Gamble, removing the products from the market and stating that benzene was not an intended ingredient of the aerosol deodorant sprays. This resulted in a growing number of deodorant recall lawsuits being filed against Proctor & Gamble.

Valisure Under Fire

The news of a potential deal between the Pentagon and Valisure comes as the FDA has raised warnings about relying too heavily on Valisure’s testing methods. However, these concerns were primarily aimed at Valisure’s pharmacy division, which the company sold off in 2021.

Despite the profound impact Valisure has had in raising red flags about widely used drugs and consumer products, both the FDA and drug manufacturers have tried to push back against the company. The FDA conducted an inspection of the lab, with inspectors reporting violations some say were not things a small lab would need to comply with if it is not making drugs, which Valisure does not.

In addition, manufacturers targeted by Valisure’s testing have floated conspiracy theories, claiming Valisure is secretly working with plaintiffs’ attorneys to fleece the companies by using faulty testing methods. However, plaintiffs’ lawyers have said they do not intend to use Valisure’s test results in trials in many of the cases, and advocates for Valisure credit the testing laboratory with helping save lives by uncovering dangers that the FDA and manufacturers either failed to discover, or failed to disclose.