A Preferable Path For Thwarting Pharmaceutical Product Hopping

The recently announced White House blueprint to curb the high cost of pharmaceuticals addresses a policy problem that both ranks near the top of consumers’ health care concerns, and is a leading reason why US healthcare spending is the highest among OECD nations. Many critics attribute significant blame to pharmaceutical companies that engage in what is euphemistically called “life cycle management,” in which pharmaceutical firms manipulate U.S. Food and Drug Administration (FDA) processes and patent laws to extend their market exclusivity beyond an appropriate term. The FDA has held hearings seeking to restore generic drug competition, in which Commissioner Scott Gottlieb decried those who are “gaming our system,” and the agency continues to develop action s that combat strategies seeking to deter generic entry.

Read more from Barak RIchman and Arti Rai in on the Health Affairs Blog.