Statement by Michael A. Carrier to House Judiciary Committee on 'Antitrust Concerns and the FDA Approval Process'

Abstract

U.S. consumers pay billions of dollars extra each year because brands engage in anticompetitive conduct to delay generic entry. Congress can take four actions to remedy this.

First, it could pass the CREATES Act, which provides a regulatory fix for REMS abuses.

Second, Congress could make clear that REMS patents cannot be used to block generic competition.

Third, the legislature could open the 180-day bottleneck forming the basis for pay-for-delay settlements to include categories other than first-filing generics.

Fourth, Congress could take several actions to increase the transparency of citizen petitions.

Keywords: antitrust, patent, drugs, pharmaceuticals, REMS, CREATES Act, settlements, citizen petitions

JEL Classification: I18, K21, L40, L41, L43, L65, O34, O38