Two prominent U.S. senators are demanding the Food and Drug Administration provide an immediate accounting of the foreign generic drugmakers allowed to skirt bans meant to keep dangerous medication out of the United States.
The top members of the Senate Special Committee on Aging cited a recent ProPublica investigation that exposed how the FDA quietly awarded special passes to troubled manufacturers so they could continue shipping medication to Americans even after the agency barred their factories because of serious quality concerns.
“These exemptions undermine the goals of U.S. policy, threaten the safety of drugs, and place Americans’ health at risk,” the senators wrote in a bipartisan letter to FDA Commissioner Marty Makary.
Committee Chair Rick Scott, R-Fla., and ranking member Kirsten Gillibrand, D-N.Y., described “urgent concerns” about the FDA’s oversight of foreign drugmakers and whether medication coming into the United States was safe.
ProPublica found the agency granted exemptions from import bans to more than 20 foreign factories since 2013, including a Sun Pharma plant in India where quality breaches repeatedly risked the contamination of sterile injectable drugs. All told, 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 FDA said the exemptions were used to prevent shortages of essential medication. The practice, however, was largely kept hidden from doctors, pharmacists, consumers and lawmakers. Despite a 2012 law requiring the FDA to describe all the ways it was dealing with drug shortages, the agency didn’t mention the practice to Congress until 2024 — and even then, only in a single footnote of a 25-page report.
Scott said he fears for patient safety.
“We’ve seen the FDA impose import bans on foreign drug manufacturing facilities for violating basic quality and safety standards, only to later issue exemptions … that allow drugs from those same facilities to still be imported simply because they’re on a shortage list,” he said in a statement to ProPublica. “That means the FDA may be allowing potentially unsafe, low-quality drugs into American homes, and our seniors are especially at risk. That’s unacceptable.”
Sun Pharma has said it maintains “a relentless focus on quality” and is working with the FDA to resolve regulatory issues. The FDA did not immediately respond to a request for comment. The agency previously said that companies receiving exemptions from import bans were required to conduct extra drug quality testing with third-party oversight to “help assure consumer safety.”
Makary is new at the FDA: He took the helm of the agency earlier this year after he was appointed by President Donald Trump and has called for “radical transparency” in agency decision-making.
The letter from Scott and Gillibrand comes on the heels of a Senate hearing on drug safety, where a former FDA inspector who spent years in India and China said he repeatedly found “shortcuts and fraud” at substandard factories and feared bad medicine was being shipped en masse to the United States.
“What we found was terrifying,” said Peter Baker, who reported a series of failures overseas from 2012 to 2018.
Baker said his findings and those of other inspectors were undermined by the exemptions from import bans.
Inspectors over the years have uncovered filthy water, vials of medication that were “blackish” from contamination and raw materials tainted with unknown “extraneous matter” at foreign factories, government records show. Documents on drug quality testing have been destroyed, and in one case, workers poured acid on some that had been stuffed in a trash bag.
ProPublica found the decisions to override those findings and exempt drugs from import bans were made by a small, secretive group of agency insiders who reported to the longtime head of drug safety, Janet Woodcock.
In an interview, Woodcock told ProPublica that the FDA believed the exempted drugs were safe. “We felt we didn’t have to make it a public thing,” she said.
Woodcock retired in 2024 after nearly four decades at the agency.
In their letter to Makary, the senators asked the FDA to explain how it defines a drug shortage and provide market share data for all drugs exempted from import bans since 2020. They also asked for a complete list of those drugs.
The FDA has never released such a list. ProPublica published one in August after a yearlong investigation. Reporters harnessed artificial intelligence and wrote code that used keyword search and pattern matching to pull exempted drug names and manufacturing locations from hundreds of old reports that were put out by the FDA and are no longer on the agency’s website. The reports identified factories barred from shipping drugs to the United States and at times referenced the exemptions with almost no explanation.
ProPublica found the FDA did not regularly test the exempted drugs to ensure they were safe or use its massive repository of drug-related complaints to proactively track whether they were harming unsuspecting patients.
“I am deeply concerned by the FDA’s pattern of allowing foreign generic drugmakers to export drugs to America even when their facilities have been found to fall below our standards,” Gillibrand said. “This is a threat to our seniors and our national security.”
Several House members have also raised concerns.
“The FDA should never have allowed corporations with unsafe foreign factories to import risky drugs or ingredients,” Rep. Chris Deluzio, D-Pa., said in a statement. “We need stronger and better domestic pharmaceutical manufacturing, and we need a government that refuses to roll the dice on our health.”
The senators asked the FDA to provide more information about the exemptions by mid-October. The committee is planning to hold a second hearing.
