The FDA’s Lax Generic Drug Rules Can Put Patients’ Lives at Risk

Wrapped in a flashy fur coat she’d found at a thrift store for the occasion, Hannah Goetz blew out the candles on her favorite red velvet cheesecake. It was her 21st birthday. The celebration with her family that evening in February 2023 was a milestone not just for her age, but because she was alive.

Three and a half years before, her lungs had collapsed from cystic fibrosis. She was saved by a double-lung transplant that had been allowing her to breathe deeply. Hannah had slowly worked her way back to stable health, overcoming infections and, every day, taking a crucial medication to protect her donated lungs from rejection. Her doctors were optimistic.

Hannah had been feeling well enough to sing karaoke, work as a nanny while taking college classes and begin her first adult relationship, with a Navy sailor. Her 21st birthday gift from her mom was a trip to Nashville, Tennessee, where the two of them and their friends could explore the city’s music scene and cavort in its bars.