Two influential U.S. senators are pressing the Food and Drug Administration (FDA) for a comprehensive list of foreign generic drug manufacturers that have been allowed to bypass import bans aimed at preventing dangerous medications from entering the United States. This demand comes in light of a recent investigation by ProPublica that revealed how the FDA granted special exemptions to troubled manufacturers, permitting them to send drugs to American consumers despite serious quality control issues at their facilities.
In a bipartisan letter addressed to FDA Commissioner Marty Makary, Senate Special Committee on Aging Chair Rick Scott (R-Fla.) and ranking member Kirsten Gillibrand (D-N.Y.) expressed their grave concerns regarding the FDA’s oversight of foreign drug producers and the potential risks posed to public health by medications entering the country from these factories.
“These exemptions undermine the goals of U.S. policy, threaten the safety of drugs, and place Americans’ health at risk,” the senators wrote, highlighting the urgent need for accountability and transparency within the agency’s drug approval processes.
ProPublica’s investigation detailed how the FDA has granted exemptions from import bans to over 20 foreign factories since 2013, including a notorious Sun Pharma plant in India, which has been repeatedly flagged for compromising the sterility of its injectable drugs. The report found that the FDA allowed more than 150 drugs or their ingredients to be imported from these banned facilities, including essential medications like antibiotics and chemotherapy treatments.
While the FDA claimed that these exemptions were necessary to prevent shortages of critical medications, the practice was largely concealed from healthcare professionals, patients, and lawmakers. Despite a 2012 law mandating the FDA to report its strategies for handling drug shortages, the agency did not disclose its exemption practices to Congress until 2024, and even then, it was buried in a footnote of a lengthy report.
Senator Scott expressed his alarm over the implications 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 stated. “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 responded by asserting its commitment to quality and its cooperation with the FDA to address regulatory concerns. The FDA has maintained that companies receiving exemptions are required to conduct additional quality testing with third-party oversight to ensure consumer safety.
Makary, who assumed leadership of the FDA earlier this year, has advocated for increased transparency in the agency’s decision-making processes amid rising scrutiny. The senators’ letter follows a recent Senate hearing on drug safety, where a former FDA inspector revealed alarming findings of “shortcuts and fraud” at substandard international factories, raising fears about the influx of unsafe medications into the U.S. market.
“What we found was terrifying,” remarked Peter Baker, the former inspector who documented failures at foreign manufacturing plants between 2012 and 2018. Baker emphasized that the FDA’s exemptions from import bans compromised the integrity of the inspection process.
Over the years, inspectors have reported egregious conditions at foreign manufacturing sites, including contaminated water supplies, contaminated vials of medication, and raw materials tainted with unknown substances. Disturbingly, records related to drug quality testing have been destroyed, and in one case, workers disposed of critical documents in a trash bag, dousing them in acid.
ProPublica’s investigation uncovered that the decision-making process for granting exemptions was concentrated within a small, secretive group of FDA officials who reported to Janet Woodcock, the longtime head of drug safety. In an interview, Woodcock defended the agency’s actions, stating that the FDA believed the drugs granted exemptions were safe and did not see the need for public disclosure about the exemptions.
The senators are demanding that the FDA clarify its definition of a drug shortage and provide detailed market share data for all drugs exempted from import bans since 2020. They also requested a complete list of these drugs, a request the FDA has never fulfilled. In contrast, ProPublica published its own list in August, compiled through extensive investigation and the use of artificial intelligence to sift through old FDA reports that had been removed from the agency’s website.
The investigation further found that the FDA did not regularly test the exempted drugs to verify their safety nor did it utilize its extensive repository of drug-related complaints to monitor potential harm to patients.
Senator Gillibrand expressed her deep concern over the FDA’s pattern of allowing foreign generic drugmakers to import drugs despite known safety violations. “This is a threat to our seniors and our national security,” she stated.
Concerns about the FDA’s practices have not only been raised by senators but also by several House members. Representative Chris Deluzio (D-Pa.) criticized the agency for permitting corporations with unsafe foreign factories to import potentially harmful drugs, calling for stronger domestic pharmaceutical manufacturing and a government that prioritizes public health over profit.
The senators have requested that the FDA provide this crucial information regarding exemptions by mid-October and are planning a subsequent hearing to further investigate these alarming practices. As the scrutiny intensifies, the push for transparency and accountability in the FDA’s regulation of foreign drug manufacturers is becoming increasingly urgent.
