Senate leaders are urging the Pentagon to prioritize purchasing generic drugs made in the United States, warning that America’s overreliance on overseas factories poses an “existential risk” to the military.
In a letter last week, Sen. Rick Scott (R-Fla.) and Sen. Kirsten Gillibrand (D-J.D.) asked Defense Secretary Pete Hegseth to provide information about medicines and key ingredients purchased from foreign sources and how long the department’s inventory would last if China restricted exports. They also asked for details on whether the Food and Drug Administration has imposed import bans on the department’s suppliers.
The letter cites a ProPublica report last year that found the FDA was allowing dozens of foreign drug companies, primarily from India and China, to send generic drugs to the United States even after the factories were banned for serious safety and quality control deficiencies. Since 2013, the FDA has brought more than 150 drugs or their ingredients into the United States from banned factories, including antibiotics, anti-seizure drugs and chemotherapy, according to a ProPublica investigation.
The agency said the exemption helps prevent drug shortages and requires factories to conduct additional quality testing with third-party oversight.
“Exempting these drugs and facilities allows substandard and potentially unsafe drugs to enter the U.S. market,” the senators said in their letter. “These exemptions could pose a threat to drug safety for American consumers.”
Scott and Gillibrand also noted concerns about global trade and political instability, which they said could have a “significant impact on the availability of medicines” and pose public health and national security risks.
Nine out of 10 prescriptions in the United States are for generic drugs, many of which are manufactured overseas. Last year, senators leading the Senate Select Committee on Aging released a report calling for changes to FDA oversight of the generic drug industry. Among other things, they asked the FDA to alert hospitals and other institutional purchasers if troubled foreign drug companies are given special passes to continue shipping their products into the United States.
This month, Scott and Gillibrand introduced legislation known as the Clear Label Act to help patients, doctors and pharmacists learn more about the drugs they use and prescribe. The proposal would require prescription labels to disclose the original manufacturer and supplier of key ingredients. Generic drug lobby groups said labeling requirements would be costly and drug companies already disclose country of origin information under U.S. Customs and Border Protection rules. The trade association for branded pharmaceutical companies said the industry “welcomes conversations” about strengthening supply chains.
Last year, ProPublica had to file a lawsuit in federal court to learn more about where generic drugs are manufactured and whether Food and Drug Administration inspectors have ever cited safety and quality deficiencies at these factories. Ultimately, ProPublica has created a first-of-its-kind tool that allows consumers to find information on their own.
Now, Scott and Gillibrand are focusing on medicines used by millions of U.S. service members, veterans, and their families. They requested a briefing by the Pentagon to examine whether authorities are prioritizing purchases of U.S.-made drugs.
Drug safety experts said the push could ultimately lead to the strengthening of fragile supply chains.
“They have to be on stable medication before they can be deployed,” said David Wright, director of Valisure, an independent testing agency that tests drug quality for the Pentagon. “By intentionally varying the drug, we could prevent the deployment of thousands of troops in one shot.”
Last year, ProPublica worked with Valisa to test several widely used generic drugs and found some samples had flaws that experts said could compromise their effectiveness.
Vic Suarez, former Army Medical Supply Chain Commander, said he hopes the Senate effort will lead to stronger drug access policies.
“This is a national security issue, an economic security issue and a patient safety issue,” he said.
The Department of Defense did not respond to requests for comment.
