Nearly 50 health care and consumer groups, including the AHA, voiced their support for the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act as it was reintroduced yesterday in the new Congress. “The CREATES Act will help ensure that brand-name pharmaceutical companies cannot take advantage of regulatory rules to forestall the competition that is essential for access and innovation,” the groups said in a letter to the bill’s sponsors, Sens. Chuck Grassley, R-Iowa, Patrick Leahy, D-Vt., Amy Klobuchar, D-Minn., and Mike Lee, R-Utah. “With its enactment, the CREATES Act will save patients and taxpayers $3.9 billion over 10 years, according to the Congressional Budget Office, by allowing lower-priced generic drugs to enter the market earlier. We also recognize and appreciate the commitment from Health and Human Services Secretary Alex Azar and Food and Drug Administration Commissioner Scott Gottlieb, M.D., on this important issue. Both have elevated awareness of brand manufacturer ‘gaming’ of FDA regulatory rules to deny would-be generic competitors the ability to purchase samples of brand-name drugs necessary to conduct the FDA-required testing and bring more affordable medicines to market.”

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