posted by AHIP
on June 13, 2018
AHIP has addressed a letter to leaders of the Senate Judiciary Committee, expressing our strong support for S. 974, the “Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act.”
This bill offers common-sense reforms that would discourage brand-name drug manufacturers from blocking the availability of generic drugs by abusing Risk Evaluation and Mitigation Strategies (REMS) that are otherwise required by the Food and Drug Administration (FDA) to promote patient safety. If CREATES is enacted, branded manufacturers will no longer be able to hide behind REMS and limited distribution arrangements to restrict access to adequate samples of reference drugs in order to impede the development of lower-cost generic competitors.
By reducing barriers to the entry of lower-cost generic drugs into the marketplace, this legislation takes an important step toward providing the American people relief from out-of-control drug prices.