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LCA Backs Effort to Create "Breakthrough Therapy" Accelerated Development Program

LCA joined 44 organizations in a letter to Senate Health, Education, Labor & Pension Leadership advocating the establishment of a “Breakthrough Therapy” designation for new drugs that show a high magnitude of clinical activity early in their development.  The intent is encourage use of strategies to expedite getting new, more targeted drugs to patients who desperately need them, as well as avoid giving large numbers of patients potentially harmful or ineffective clinical trial designs, or specific strategies for accumulating further evidence on the breakthrough drug after it is approved.   This designation is being sought within the upcoming reauthorization of the Prescription Drug User Fee Act (PDUFA).

Click here to see the letter.