Report

Modernizing Drug Discovery, Development & Approval

PhRMA March 31, 2016

Developing an innovative medicine is a lengthy and complex process, taking an average of 10 or more years. The clinical trial component alone takes roughly six to seven years. With just 12 percent of drugs that enter clinical trials resulting in an approved medicine, the average research and development cost for each successful drug is estimated at $2.6 billion (including the cost of failures). Against this backdrop, pro-patient, pro-science, pro-market reforms at the Food and Drug Administration (FDA) would enhance the competitive market for biopharmaceuticals, drive efficiency in drug development and discovery and help hold down costs.

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