The CREATES Act combats anticompetitive practices used by some brand-name pharmaceutical and biologic companies to delay the approval of lower-cost generic drugs
WASHINGTON- U.S. Senator Amy Klobuchar (D-MN), Ranking Member of the Senate Judiciary Subcommittee on Antitrust, Competition Policy and Consumer Rights, announced today that bipartisan legislation she cosponsored to address the rising costs of prescription drugs has passed the Senate Judiciary Committee. The Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act would combat anticompetitive practices used by some brand-name pharmaceutical and biologic companies to delay the approval of lower-cost generic drugs. The CREATES Act was originally introduced by Klobuchar and Senators Patrick Leahy (D-VT), Chuck Grassley (R-IA), and Mike Lee (R-UT) in June of 2016.
“The rising cost of prescription drugs in our country is an urgent problem,” Klobuchar said. “Competition, not anti-consumer actions from pharmaceutical companies, should determine prescription drug costs. With the passage of the bipartisan CREATES Act out of the Senate Judiciary Committee, we are one step closer to ending the unfair practices that drive up prescription drug costs and helping Americans access the affordable prescription drugs they need.”
The CREATES Act address two types of delaying tactics: (1) when brand-name drug companies prevent potential generic competitors from obtaining samples of a product and (2) when brand-name drug companies block their generic competitors from participating in shared safety programs to ensure drugs are used safely. Both of these tactics prevent generic companies from performing the necessary testing and distribution necessary for U.S. Food and Drug Administration (FDA) approval. By combatting these anticompetitive barriers, the CREATES Act would help consumers get access to lower cost generic drugs more quickly. The Congressional Budget Office (CBO) estimates that the bill would result in almost $4 billion in savings.
Klobuchar has championed efforts to protect consumers and lower prescription drug costs by promoting competition in the healthcare system, authoring multiple pieces of bipartisan legislation that would address the high cost of prescription drugs. Klobuchar introduced legislation—that has 34 cosponsors—to lift the ban on Medicare negotiating for the best possible price of prescription drugs for nearly 41 million seniors enrolled in Medicare Part D. Last year, Klobuchar and Senator John McCain (R-AZ) introduced the Safe and Affordable Drugs from Canada Act, bipartisan legislation that would allow individuals to safely import prescription drugs from Canada. Klobuchar has also introduced the bipartisan Preserve Access to Affordable Generics Act with Senator Chuck Grassley (R-IA) to limit “pay for delay” deals—the practice of brand-name drug companies using anti-competitive pay-off agreements to keep more affordable generic equivalents off the market. Klobuchar’s Short on Competition Act, introduced with Senator Mike Lee (R-UT), would allow temporary importation of drugs that have been approved in another country with similar safety requirements and face little or no competition in the U.S.
Video of Klobuchar speaking is available for download here: KLOBUCHAR_JUDIC_061418.mp4