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Lawmakers at the helm of the Senate Special Committee on Aging have proposed a sweeping series of changes that could transform the way the government safeguards the quality of essential generic drugs.
Citing a recent ProPublica investigation, the senators said the Food and Drug Administration should alert hospitals and other group purchasers when foreign drugmakers with serious safety and quality failures are given a special pass to send their products to the United States.
Since 2013, ProPublica found, the FDA quietly allowed more than 20 troubled overseas factories, mostly in India, to continue to send certain medications here even after those facilities were banned because of concerns about contamination and other breaches. The agency didn’t actively track whether the imported drugs were harming users and kept the practice largely hidden from the public and Congress.
In a recently released investigative report, the committee chair, Sen. Rick Scott, R-Fla., and ranking member Sen. Kirsten Gillibrand, D-N.Y., criticized the FDA for failing to notify Congress “in any way” about the practice, calling it a “failure on the FDA’s part to protect public health.”
Scott and Gillibrand also called on the FDA to conduct more testing of generic drugs rather than rely on assurances from foreign manufacturers that their medications are safe and effective. India supplies about half of all generic drugs used in the United States, and many of the key ingredients are produced in China, according to the report.
“The United States’ overreliance on foreign-made generic drugs, especially those made in adversarial nations, is a very real threat to all Americans, but especially our aging population,” Scott said.
The report marks a significant expansion of the senators’ bipartisan call to protect the U.S. drug supply.
After a hearing last month, Scott and Gillibrand demanded the FDA provide an immediate accounting of all foreign generic drugmakers allowed to skirt import bans. And last week, they sent a letter to Health and Human Services Secretary Robert F. Kennedy Jr. seeking a briefing about the drug supply chain and the risk of shortages. The letter also cited ProPublica’s reporting about the FDA’s exemptions from import bans, saying they could pose “a threat to drug safety for American consumers.”
The FDA has said that the exemptions were granted to prevent shortages and that manufacturers were required to conduct extra quality testing with third-party oversight to ensure the medications were safe.
HHS, which oversees the FDA, declined to comment about the investigative report or the letter to Kennedy when contacted by ProPublica, saying the agency would respond directly to the senators.
The 34-page report largely focuses on shoring up domestic manufacturing. The senators cited an academic study released this year that found generic drugs made in India were tied to far more hospitalizations, deaths and other adverse events than the equivalent medications manufactured in the United States.
“We let the industry go offshore for cost reasons without adjusting the regulatory infrastructure to be able to handle it appropriately,” said Ohio State University professor John Gray, who co-authored the study. “There’s this race to the bottom … that leads to fragility and shortages and also potential quality issues.”
Notably, the senators suggested the Department of Defense could help launch a “federal buyer’s market” that prioritizes the purchase of drugs from domestic manufacturers. The federal government, with agencies that include the Department of Veterans Affairs, is the largest purchaser of drugs in the United States.
The DOD is currently conducting its own testing of generic drugs widely used by American service members and has already reported finding potency and other quality issues.
“If these recommendations are put into action, then it really resets the table of the health care system in the United States,” said retired Army Col. Vic Suarez, who helped launch the DOD’s testing project. “When you combine all the federal agencies to do this in one aligned acquisitions strategy, it just has a really exponential impact that we’ve never seen before.”
The senators said if domestic manufacturing capacity is ramped up in the coming decade, federal purchasers could be required to buy drugs made in the United States with American-made ingredients.
The report also focused on transparency, saying that manufacturers should disclose on product labels the country where medications and their key ingredients are made.
“In the richest country in the world, our constituents shouldn’t have to worry about the safety and availability of the drugs they need to fight devastating diseases,” Gillibrand said.
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