Short Wave The Accelerated Approvals Process: Are Drugmakers Fulfilling Their Promises?
Jul 22, 2022
Sydney Lupkin, NPR's pharmaceuticals correspondent, dives into the world of accelerated drug approvals and the promises drugmakers must keep. She discusses the urgent history behind this FDA process, particularly during the AIDS crisis. Lupkin reveals concerning stories, including tragic outcomes linked to insufficiently validated drugs. The conversation sheds light on the challenges of ensuring ongoing accountability and the dire need for thorough follow-up studies to protect patient safety and trust in the pharmaceutical system.
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Michael's Battle with Leukemia
- Michael Alciaga, a 16-year-old, battled acute lymphoblastic leukemia and underwent various treatments, including an experimental drug.
- Despite initial optimism, the treatments failed, and he tragically passed away.
Clofarabine's Accelerated Approval
- The FDA granted accelerated approval to Clofarabine, the chemo Michael received, in 2004.
- However, for 18 years, the required confirmatory trial remained incomplete, raising concerns about its efficacy.
Origins of Accelerated Approvals
- Accelerated approvals originated during the AIDS crisis due to the urgent need for new treatments.
- The FDA's approval of DDI in 1991, based on its effect on white blood cells, marked the first unofficial accelerated approval.