When Joe DeMayo received a kidney from his wife at age 33, it was a life-changing gift. He knew the kidney wouldn’t last forever, but he hoped for many healthy years, especially with a toddler at home. What he didn’t expect was that the very medication meant to protect his transplant might contribute to its failure. A ProPublica investigation reveals serious concerns about the oversight of generic drugs and the decisions made by the FDA, one of the most powerful drug regulators in the world.*

A Second Chance Endangered

DeMayo moved from Philadelphia to northern California after his transplant, looking forward to a fresh start and time with his young family. For nearly a decade, things went well. But in early 2023, his donated kidney began to fail, far sooner than expected. He was taking his medications carefully, including tacrolimus, a drug that suppresses the immune system to prevent organ rejection.

What DeMayo didn’t know was that his tacrolimus came from a factory in India that had been flagged by the FDA multiple times since 2015. Inspectors had found problems ranging from data manipulation to contamination risks. Still, the factory, owned by Intas Pharmaceuticals, was allowed to continue shipping drugs to the U.S. without warning patients.

Loopholes, Exemptions, and a Lack of Transparency

When the FDA finally barred the Intas plant from exporting to the U.S. in late 2023, it didn’t issue a full stop. Instead, it exempted certain drugs from the ban; tacrolimus was one of them. This move, part of a long-standing policy intended to prevent drug shortages, meant that even after serious quality issues were found, some medications continued reaching American patients.

The catch? These exemptions weren’t well-publicized. Doctors and patients were left in the dark. Although companies receiving exemptions are supposed to conduct extra safety checks, former FDA officials and outside experts say those requirements are often ineffective and rarely enforced in any meaningful way.

Lab Results Raise Red Flags

To better understand what might have gone wrong, DeMayo gave two bottles of his tacrolimus to ProPublica, which had them tested by an independent lab called Valisure. The results were eye-opening: some pills didn’t have enough of the active ingredient, while others dissolved much faster than they should. That kind of inconsistency can be dangerous, potentially triggering side effects or leading to organ rejection.

The FDA’s own research found similar issues. Still, just weeks after publishing those findings, the agency allowed the drug to remain exempt from the Intas ban. DeMayo, who had a second transplant in early 2024, can’t say for sure whether the medication was to blame for his failing kidney. But the questions linger — and they’re not his alone.

“This isn’t just about me,” he said. “There are so many people depending on these drugs. How did it get this bad?”

A Call to Action

Joe DeMayo’s story should be a wake-up call—not just for regulators, but for everyone involved in patient care.

If you’re a transplant recipient, caregiver, or healthcare provider, don’t assume all medications are equal. Ask questions. Know where your medications come from. Report unusual side effects or treatment failures. Pharmacists, physicians, and hospital systems should demand transparency from manufacturers and insist on rigorous quality checks, especially for life-sustaining drugs.

As for advocates and policy leaders, push for reform. Exemptions from import bans should never be hidden from the public, and drug quality should never be sacrificed in the name of convenience. Patients’ lives depend on it.

*Cenziper, D. and Rose, M. (2025, June 23). His Kidney Failed. He’ll Never Know if a Transplant Drug From a Banned Factory Was to Blame. Pro Publica. https://www.propublica.org/article/fda-tacrolimus-kidney-transplant-patient 

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