When David Mitchell learned he had an incurable blood cancer seven years ago, the out-of-pocket cost for a month’s supply for one of his medicines was $42. By 2016, it had jumped to $250.
A lower-cost generic wasn’t an option because Celgene (CELG), the drug’s manufacturer, refused to provide samples to generics makers for the product testing they need to do to win marketing approval. Why? The company cited constraints imposed by a regulatory program meant to ensure drug safety.