Senate leaders are urging the Department of Defense to prioritize the purchase of generic drugs manufactured in the United States, warning that the country’s overreliance on foreign factories poses an “existential risk” to the military.
In a letter last week, Sens. Rick Scott, R-Fla., and Kirsten Gillibrand, D-N.Y., asked Defense Department Secretary Pete Hegseth to provide information about drugs or key ingredients purchased from foreign sources and how long the department’s inventory would last if China restricted exports. They also sought details about whether the Food and Drug Administration had imposed any import bans on the department’s suppliers.
The letter cited ProPublica reporting last year that found the FDA allowed dozens of foreign drugmakers, mostly in India and China, to continue sending generic medication to the U.S. even after the factories were banned because of serious safety and quality-control failures. Since 2013, ProPublica found, the FDA allowed more than 150 drugs or their ingredients into the United States from banned factories, including antibiotics, anti-seizure drugs and chemotherapy treatments.
The agency has said that the exemptions helped prevent drug shortages and that factories were required to conduct extra quality testing with third-party oversight.
“Exempting these drugs or facilities allows for substandard and potentially unsafe drugs to enter the U.S. market,” the senators wrote in their letter. “These exemptions can pose a threat to drug safety for American consumers.”
Scott and Gillibrand also noted they are worried about instability in global trade and politics, which they said can create “profound ramifications for the availability of medications” and pose public health and national security risks.
Nine in 10 prescriptions in the United States are for generics, many of them made overseas. Last year, the senators, who lead the Senate Special Committee on Aging, released an investigative report demanding changes in the FDA’s oversight of the generic drug industry. Among other things, they asked the FDA to alert hospitals and other group purchasers when troubled foreign drugmakers are given a special pass to continue sending their products to the United States.
This month, Scott and Gillibrand introduced legislation known as the Clear Labels Act to help patients, doctors and pharmacists know more about the drugs they use and prescribe. The proposal calls for prescription labels to disclose the original manufacturer as well as the suppliers of key ingredients. The generic drug lobbying group has said that the labeling requirements would be costly and that drug manufacturers already disclose country of origin information under U.S. Customs and Border Protection rules. The trade group for brand-name drugmakers said the industry would “welcome conversations” about strengthening the supply chain.
ProPublica had to sue the FDA in federal court last year to learn more about where generic drugs were made and whether the agency’s inspectors had ever flagged those factories for safety and quality lapses. ProPublica ultimately created a first-of-its-kind tool that empowers consumers to find the information themselves.
Now, Scott and Gillibrand are turning their attention to the medications used by millions of U.S. servicemembers, veterans and their families. They requested a briefing by the Pentagon to explore whether officials are prioritizing the purchase of American-made drugs.
Drug safety experts said the push could ultimately help shore up a vulnerable supply chain.
“Before you can be deployed, you have to be stable on your medications,” said David Light, president of the independent testing lab Valisure, which is conducting drug-quality testing for the Defense Department. “If you purposely add more variability to your drugs, you could prevent the deployment of thousands of troops without a single shot.”
Last year, ProPublica engaged Valisure to test several widely used generic drugs and found several samples had irregularities that experts say could compromise their effectiveness.
Vic Suarez, a retired Army medical supply-chain commander, said he hopes the effort in the Senate will lead to stronger drug acquisition policies.
“This is a national security issue. It is an economic security issue. And it is a patient safety issue,” he said.
The Department of Defense did not respond to a request for comment.
