FDA Worries CREATES Could Lead To Further Gaming, FTC Disagrees

FDA has told sponsors of a closely watched Risk Evaluation and Mitigation Strategies reform bill that while it supports the goal of the legislation, it worries that it could actually allow further gaming intended to delay generic competition. However, the Federal Trade Commission, which also weighed in on the bill, argued that those concerns are likely overblown. The Senate Judiciary Committee on June 7 began the process of marking up the Creating and Restoring Equal Access to Equivalent Samples (CREATES)...