FDA's drugs center wants to revisit a proposal once entertained by PhRMA to allow the agency access to all data from failed drug development programs to research whether different approaches could have saved the products.
The idea was explored before, but an agreement was never reached. CDER deputy director for clinical science Bob Temple is pitching it again based on statements that the industry is more willing to share internal data.
Phase 3 failures continue at an alarming rate, Temple acknowledged during a joint FDA/Drug Information Association workshop on drug development in Bethesda, MD. These “destroy optimism,” he said, adding that at least 10 years ago there were discussions with PhRMA “about a completely open review of drugs that failed in Phase 3.”
Temple's pitch followed his presentation on how better dose-response data could have saved products removed from the market after approval. For example, Lotronex, for IBS associated with diarrhea, was pulled because of severe side effects at its original dose, but is back on the market at a reduced dose.