How many innovative, potentially lifesaving drugs never make it to the marketplace because of the added costs in time and money imposed by the [Kefauver-Harris] Amendments? No one knows for sure, but the studies that have been done imply that we’ve lost about 80% of the innovations that we would have had in the absence of he Amendments.

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Quote text and notes from Wikiquote: Mary Ruwart (page history), available under CC BY-SA 4.0. Source quality and labels are our own summary of what Wikiquote records.