Source: This report is based on the investigative article “His Kidney Failed. He’ll Never Know if a Transplant Drug From a Banned Factory Was to Blame” by Debbie Cenziper and Megan Rose, originally published by ProPublica on June 23, 2025.
For a transplant recipient, a life-saving organ is a precious gift with a finite lifespan. For Joe DeMayo, a father who received a kidney from his wife, every day of health was a blessing. He took his medication faithfully, trusting the system designed to protect him. But when his transplanted kidney began to fail far sooner than expected, a disturbing question emerged: could the very drug meant to save him have contributed to its demise?
A groundbreaking investigation by ProPublica has uncovered a story that strikes at the heart of patient trust and regulatory oversight. It raises critical questions about the safety of generic drugs entering the U.S. market and the secret compromises made by the Food and Drug Administration (FDA).
A Patient’s Trust and a Factory’s Failures
Joe DeMayo’s story begins with hope. After his first transplant, he moved to California, started a family, and lived a full life. His shield against organ rejection was tacrolimus, a powerful immunosuppressant he took twice a day, every day.
Unbeknownst to him, the tacrolimus he relied on was manufactured by Intas Pharmaceuticals at a factory in India with a long history of compliance issues. The ProPublica report highlights that since 2015, the FDA had repeatedly found problems at this facility. In the spring of 2023, as DeMayo’s health was declining, FDA investigators discovered the factory was manipulating drug-testing records, including hiding the presence of contaminants in its products.
In November 2023, the FDA took action, barring the Intas factory from exporting drugs to the United States. However, in a move that is both shocking and largely hidden from the public, the agency made a critical exception.
The FDA’s Secret Gamble: Banned but Exempted
ProPublica’s investigation revealed that the FDA has a long-standing practice of exempting certain “medically necessary” drugs from factory-wide import bans, ostensibly to prevent shortages. Over the last dozen years, more than 150 drugs or their ingredients from banned factories have been allowed into the country under this exemption.
DeMayo’s tacrolimus was one of them.
This raises an immediate and alarming question: If a factory’s quality control is so poor that it warrants a ban, how can any of its products be considered safe? The FDA’s stance is that these exempted drugs undergo extra testing. Yet, many of these same companies have already been cited for fraudulent or ineffective testing protocols.
The Science Reveals a Disturbing Picture
DeMayo provided his unused Intas tacrolimus capsules to ProPublica, which had them independently tested by Valisure, an accredited lab. The results were concerning:
- Underdosing: Some pills contained less of the active ingredient than the minimum level set by U.S. regulations. For a transplant patient, underdosing can leave them critically vulnerable to organ rejection.
- Rapid Dissolution: The capsules dissolved up to three times faster than the brand-name version. Experts warn this can flood the body with too much of the drug at once, potentially causing toxic side effects—including the very kidney damage the drug is supposed to prevent.
Disturbingly, the FDA’s own studies had previously shown similar results, noting the Intas generic could create toxins and might not provide the same therapeutic effect as the brand-name drug. The agency published these findings in September 2023—just weeks before it exempted the drug from the import ban.
A Call for Accountability and a Conversation We Must Have
Joe DeMayo has since received a second kidney transplant. While he will never know for certain if the Intas-made tacrolimus caused his first transplanted kidney to fail, his story is a powerful warning for millions of Americans who rely on generic medications.
It forces us to confront difficult truths about the global pharmaceutical supply chain and the regulators we entrust with our health. As patients, we have a right to know if the medicine in our cabinet comes from a facility with a documented history of hiding contaminants and failing quality checks. For more information on kidney health, you can visit the National Kidney Foundation.
This isn’t just one patient’s story; it’s a systemic issue that demands transparency and accountability. (Read more about our health policy analysis at ICAEPA [here – internal link placeholder]).
We want to hear from you. This is a space for discussion.
- What does this story say about the trust we place in our medications and the FDA?
- Should the FDA be forced to publicly disclose which drugs are granted exemptions from import bans?
- Have you or a loved one ever had an experience that made you question the quality of a generic drug?
Share your thoughts, reactions, and experiences in the comments below. Let’s start a conversation.