This week, the FDA did something rare: it reversed itself, and said it would no longer require further study of a drug for a rare disease. Instead, the FDA said the drug company could go ahead and seek approval of the drug with just the data from previous clinical trials. There have been other instances in recent months of the FDA allowing drugs to move through the approval process more quickly.
Adam Feuerstein (@adamfeuerstein), national biotech columnist for STAT, joins Here & Now‘s Meghna Chakrabarti to look at whether there’s a shift in how drugs are being regulated and approved at the FDA under President Trump and FDA Commissioner Scott Gottlieb.
Copyright 2021 NPR. To see more, visit https://www.npr.org.