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Two prominent US senators are asking the Food and Drug Administration to provide immediate accounting for foreign generic drug manufacturers who are permitted to ban skirts aimed at keeping dangerous drugs out of the United States.
Top members of the Senate Special Committee cited a recent Propublica survey that exposed the way the FDA quietly awarded special passes to troubled manufacturers.
“These exemptions undermine U.S. policy goals, threaten drug safety and put American health at risk,” the senator wrote in a bipartisan letter to FDA Commissioner Marty McCurry.
Committee Chairman Rick Scott, R-Fla. and ranking member Kirsten Gillibrand (DN.Y.) discussed “urgent concerns” about the FDA’s surveillance of foreign pharmaceutical manufacturers and whether drugs coming into the US are safe.
Propublica has found that since 2013, it has been exempt from import bans to more than 20 foreign factories. This includes the Indian Solar Pharma Factory where quality violations have repeatedly put sterile injectable contamination. Propublica has discovered everything the FDA has discovered. It has allowed the United States to have more than 150 drugs or ingredients from prohibited factories, including antibiotics, antiseizure drugs, and chemotherapy treatments.
The FDA said the exemption was used to prevent a shortage of essential drugs. However, this practice was hidden primarily from doctors, pharmacists, consumers and lawmakers. Despite a 2012 law requiring the FDA to explain all the ways in which it was dealing with drug shortages, the agency did not mention practices to Congress until 2024.
Scott said he was afraid of patient safety.
“We have seen the FDA impose import bans on foreign drug manufacturing facilities in order to violate basic quality and safety standards, but they only issue exemptions later, allowing drugs from these facilities to be imported simply because they are on the shortage list,” he said in a statement to Propublica. “That means the FDA may be allowing American homes with potentially safe and low quality drugs, and our seniors are especially at risk. That’s not acceptable.”
Sun Pharma says it maintains a “relentless focus on quality” and is working with the FDA to resolve regulatory issues. The FDA did not immediately respond to requests for comment. The agency previously said companies that have been exempt from the import ban should conduct additional drug quality tests with third-party surveillance to “help to ensure consumer safety.”
McCurry is new by the FDA. He was appointed by President Donald Trump and then he took the helm of the agency earlier this year, sought “radical transparency” in agency decision-making.
Letters from Scott and Gillibrand come shortly after the Senate hearing on drug safety. There, a former FDA inspector who spent many years in India and China repeatedly discovered “shortcuts and fraud” in substandard factories, repeatedly discovering that bad medicines may be gathering in the US.
“What we found was horrifying,” said Peter Baker, who reported a series of missteps overseas from 2012 to 2018.
Baker said his findings and the discoveries of other inspectors were undermined by the exemption from the import ban.
Government records show that over the years, vials of “blackish” drugs have been discovered from dirty water, contamination. Documents regarding drug quality testing have been destroyed, and in some cases workers poured acid into what was packed into garbage bags.
Propublica found that the decision to override these findings and exempt drugs from import bans was made by a small, secret agent group that reported to Janet Woodcock, a longtime drug safety officer.
In an interview, Woodcock told Propublica that the FDA believes exempt drugs are safe. “We didn’t feel like we needed to make it public,” she said.
Woodcock retired in 2024 after nearly 40 years at the agency.
In a letter to McCurry, the senator asked the FDA to explain how it defines drug shortages and to provide market share data for all drugs exempted from import bans since 2020.
The FDA has never released such a list. Propublica announced one in August after a year of research. Using artificial intelligence, reporters used keyword search and pattern matching to write code that pulls out drug names and manufacturing locations published by the FDA and exempts them from hundreds of old reports that are not on the agency’s website. The report identified factories that were prohibited from transporting drugs to the United States, and sometimes referenced exemptions without explanation.
Propublica found that the FDA either regularly tests exempt drugs to ensure they are safe, or actively tracks whether they are hurting unsuspecting patients by using a large reservoir of drug-related complaints.
“I am deeply concerned about the FDA’s pattern of allowing foreign generic drug manufacturers to export drugs to the US, even if they find out their facilities are below our standards,” says Gillibrand. “This is a threat to our seniors and national security.”
FDA ships substandard factories to the US
Several House members have also raised concerns.
“The FDA would never have allowed companies with unsafe foreign factories to import dangerous medicines and ingredients,” D-Pa. Rep. Chris Delugio said in a statement. “We need stronger, better domestic drug manufacturing and a government that refuses to roll our health dice.”
The senator asked the FDA to provide further information on the exemption by mid-October. The committee plans to hold a second hearing.
