Shared Value for Patients and Pharmaceutical Companies

Abstract

The U.S. drugs-to-patients system fails to achieve its overall system goal of better drugs, sooner, at lower cost. The key constraint that impedes achieving this goal is the FDA's enormously expensive and time consuming clinical testing process. Fixing this constraint should be a strategic objective of the pharmaceutical industry. This objective is achievable with the Free To Choose Medicine plan, which would empower patients, advised by their doctors, to make informed decisions about whether to use approved drugs or new drugs in late stage clinical testing. Free To Choose Medicine would, in general, greatly increase the pace and effectiveness of pharmaceutical industry innovations, and in particular, shift resources to the most skilled firms in developing breakthrough medicines. Free To Choose Medicine legislation would implement a dynamic, self-adjusting system focused on benefiting patients through fast-paced learning in ways that the FDA's randomized control trials cannot accomodate. The result would be substantial shared value for patients and pharmaceutical companies.

Keywords: Free To Choose Medicine, Dual Tracking, FDA Reform, Shared Value

JEL Classification: A13, E61, H11, I11, I18, L51