Bill Aims to Prevent Brand Drug Firms Blocking Generic Entrants

Senator Patrick Leahy (D-VT) has introduced legislation to combat anticompetitive practices used by some brand-name pharmaceutical and biologic companies to block lower-cost generic drugs from entering the market. The Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act aims to put an end to brand-name drug companies preventing potential generic competitors from obtaining samples of the branded product for testing. It would also prevent brand-name manufacturers whose products require a distribution safety protocol (Risk Evaluation Mitigation Strategy with Elements to Assure Safe Use) from refusing to allow generic competitors to participate in that safety protocol. Leahy says the Congressional Budget Office has estimated that the bill would result in a $3.3 billion net decrease in the federal deficit. An outline of the CREATES Act can be found here, and text of the legislation can be found here.