“The people who oversee the pills are failing and the people who are making the pills are failing. How did it get so bad?”

— Joe DeMayo, whose donated kidney began failing in 2023, much earlier than expected. 

DeMayo took a drug called tacrolimus that was manufactured in a problem-ridden factory in India, which the Food and Drug Administration banned from exporting to the United States. But under a long-standing practice uncovered by ProPublica, the agency excluded certain medications from the factory-wide ban, including tacrolimus, allowing the drugs to continue flowing to the U.S., citing shortages. 

The FDA said drugmakers that receive a pass from import bans are required to conduct additional safety and quality testing and hire third-party experts to assess the results before shipping medication to the United States. The company that makes tacrolimus said that the drug is safe and effective and that the company immediately responded to the FDA’s inspection findings in the Indian factory. 

DeMayo said he’ll never know whether the medication contributed to the loss of his donated kidney, but he had a second transplant surgery in 2024. He’s now recovered.