Congressmen Marino and Cicilline Applaud FDA’s Public Meeting on Generic Drug Pricing

Washington, D.C.--Today, the U.S. Food and Drug Administration (FDA) held a public meeting to solicit input in areas where the FDA’s rules are being used in ways that create obstacles and delays.  FDA Commissioner Scott Gottlieb, M.D., has shown a commitment to ensuring that generic manufacturers have access to promote competition.  Commissioner Gottlieb commented last week that the FDA has seen problems with branded pharmaceutical companies using the Risk Evaluation and Mitigation Strategy, or REMS Program, to block generic companies from gaining access to samples, which may delay the entry of safe and effective generic drugs onto the market.

On April 27, 2017, Representatives Tom Marino and David N. Cicilline, Chairman and Ranking Member, respectively, of the House Judiciary Subcommittee on Regulatory Reform, Commercial and Antitrust Law, introduced H.R. 2212, the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act, to address anticompetitive conduct associated with the FDA’s REMS Program.  The CREATES Act would deter pharmaceutical companies from blocking cheaper generic alternatives from the marketplace, a problem identified by Commissioner Gottlieb. 
 
Chairman Marino and Ranking Member Cicilline issued the following statement: 

“The CREATES Act will lead to lower costs for patients by ensuring they have access to generic medicines that have been approved by the FDA while closing regulatory loopholes that are used to keep prices artificially high.  Patient safety will continue to be maintained by ensuring current safeguards.  Our constituents have consistently contacted us to express their concerns with drug pricing and competition.  The CREATES Act is a step in the right direction to ensure there is a greater choice of generics to bring drug costs down.”