The recent Amoxicillin shortage in hospitals demonstrates America’s dangerous dependence on imported pharmaceuticals. In addition to shortages, however, the U.S. is now confronting yet another challenge—medications from unsafe overseas factories. The Food and Drug Administration (FDA) recently allowed a banned factory in India to ship the lung medication Atovaquone to the U.S. It’s part of what has become essentially a pharmaceutical offshoring policy by the FDA. The agency simply ignores the need to boost domestic production and approves foreign manufacturers that repeatedly violate safety regulations.
Atovaquone is a key antibiotic used to treat lung infections. A main supplier of Atovaquone is Glenmark, a pharmaceutical company headquartered in Mumbai, India. Glenmark’s drug manufacturing facility in Baddi, India is currently under a U.S. import ban for failing to meet safe manufacturing standards. Last June, an FDA inspection of Glenmark’s Baddi facility resulted in a warning letter and “Official Action Indicated” after significant violations and objectionable conditions were found.
Now, however, the FDA is allowing Glenmark to export Atovaquone from its Baddi facility despite the ban. In a regulatory filing, Glenmark said the FDA had granted the exception “due to medical necessity and potential drug shortage expectations.”
Glenmark has a worrisome history of safety issues and product recalls. Last November, the company received a warning letter from the FDA for violations at its Goa, India factory related to batch failures, lab controls, and record-keeping. And in 2019, the company recalled shipments of Ranitidine—sold under the brand name Zantac—from two Indian factories due to potentially carcinogenic ingredients.
Glenmark isn’t the only drug maker in India experiencing safety problems. Aurobindo Pharma—America’s largest supplier of generic drugs—has also repeatedly been cited by the Food and Drug Administration (FDA) for unsafe manufacturing practices.
Last year, the FDA issued a warning letter to Aurobindo for “significant deviations” from safe manufacturing practices. And in 2019, federal regulators warned Aurobindo of “repeated failures” to address safety concerns, including “contamination at levels above the acceptable limit” and “inadequate cleaning procedures.”
Pharmaceutical manufacturers in both India and China routinely receive similar warning letters from the FDA for safety violations. These include carcinogenic ingredients in medicines as well as manufacturing processes that can result in “fatal infections in a broad array of patients.” Incredibly, the FDA has not made in-person inspections in many of these facilities in recent years—and has not visited any drug factories in China since 2019.
A major problem is the FDA’s treatment of foreign manufacturers during inspections. The agency simply conducts pre-announced and even virtual inspections of overseas facilities—something that even the FDA considers a problem. In 2021, the FDA admitted: “We recognize that remote interactive evaluations do not replace inspections, and that there are situations where only an inspection is appropriate based on risk and history of compliance with FDA regulations.”
The FDA would never view such virtual inspections as sufficient for domestic U.S. drug factories. And it would never grant them an exception after failing to meet basic safety standards. This double standard is a core part of the FDA’s culpability in offshoring America’s essential medicine production.
Such a huge disparity in oversight gives a tremendous advantage to drug makers in India and China. The FDA’s apparent favoritism to foreign drug manufacturers—regardless of their compliance history—allows them to export drugs to the United States long before America’s domestic pharmaceutical plants can receive similar clearances. As a result, it creates an offshoring incentive for overseas drug makers and cuts market share for U.S. producers.
The United States needs to launch a major effort to rebuild domestic production of essential medicines—particularly when the nation is already experiencing shortages. Instead, the FDA is granting exceptions to foreign factories that violate U.S. safety regulations.
The FDA must conduct thorough, in-person inspections of drug factories in India and China. It also must test the drugs being supplied to U.S. patients—and fully insist on safe manufacturing facilities as a condition for selling in the U.S. market.
Additionally, the FDA must ensure that every U.S. hospital, pharmacy, and doctor notifies patients when Glenmark’s Baddi products are being prescribed. And in the long term, the FDA must change its ways. It’s past time to incentivize domestic production and hold overseas drug makers accountable by banning unsafe imports before another health crisis endangers more American lives.