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New Bill Would Add More Rare Disease Experts and Patients to FDA Drug Review Process
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themighty.comWhat happened: Two women are working to change how the FDA reviews drugs for rare diseases. Lindsey Sutton — a Californian who lives familial chylomicronemia syndrome, or FCS — and Melissa Goetz, whose daughter was diagnosed with FCS, helped write the HEART Act after learning the Food and Drug Administration (FDA) does not require rare disease specialists or patients to sit in or serve on clinical trial committees to develop new treatments. “It began with our frustrations of FCS, but as we were talking with other rare disease groups and sharing our frustrations and concerns with them, we realized that this was not only an FCS-specific issue,” Goetz told CNN. “A lot of other rare disease groups were struggling to get treatments for their
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