The Complexity of Integrating Speed and Safety in Drug Development

Abstract

This publication proposes a comprehensive and collaborative approach to developing and approving medications to better align industry incentives and patient interests. Shorter, smaller trials could allow patients faster access to new therapies that cost less. To achieve this end, some propose that once the absence of major drug risks have been confirmed, the remaining effort to prove efficacy and safety should be moved postmarket. Limitations on the marketing and prescribing of these recently approved drugs would provide time for studies to reveal information about their effectiveness and safety. However, there are legal challenges to doing so due to the explosive growth in direct-to-consumer advertising, most recently addressed in US v. Caronia. A conditional approval system may alleviate some of the market tension between marketing restriction and commercial speech in the US, but may still fail to address the need for companies to receive a reasonable return on investment in light of intensified postmarket surveillance and approval restrictions. Thus, other types of financial incentives for industry such as grants, rewards, prizes, and tax credits could provide the necessary supplemental revenue for research and development. Ultimately, enhanced safety measures can generate the confidence needed to permit earlier drug release and economic incentives can encourage research and development despite less predictable postmarket profits.

Keywords: FDA, Drug Safety, Pharmaceuticals

JEL Classification: K2