WASHINGTON--Senator Chuck Grassley, Chairman of the Senate Judiciary Committee, is introducing new legislation to combat rising drug prices for Iowans by deterring brand-name pharmaceutical companies from blocking the entrance of more affordable generic alternatives in the marketplace. Along with Grassley, the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act is being led by Senators Patrick Leahy, Mike Lee, and Amy Klobuchar.
Current law allows for a streamlined approval process whereby generic drug companies can conduct testing of generic versions of a brand-name drug prior to its patent expiration. However, concerns have been raised that some brand-name companies are misusing an FDA program, known as the Risk Evaluation and Mitigation Strategy, to thwart that process by preventing the sale of samples of their product and refusing to allow generic competitors to participate in their Risk Evaluation and Mitigation Strategy protocol. These tactics result in blocking generic drug approval and keeping drug prices high for consumers. The Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act addresses this anticompetitive behavior by giving generic companies an opportunity to obtain relief in a timely fashion rather than through lengthy antitrust litigation.
"The rising cost of prescription drugs is a consistent topic at my Q&A meetings in Iowa. Balancing the cost of developing lifesaving medications with the need to make available affordable prescription drugs to consumers has always been a difficult task,” Grassley said. “Unfortunately, we’re seeing some brand-name drug companies engage in anti-competitive tactics that delay entry of lower cost generic drugs into the market. This bill takes important steps to ensure that our laws are not frustrated and consumers have access to less expensive generic drugs in a timely fashion.”
Grassley is also a co-author of the Preserve Access to Affordable Generics Act which would make sure consumers have access to cost-saving generic drugs by making it illegal for brand-name and generic drug manufacturers to enter into anti-competitive pay-off agreements.
The CREATES Act is supported by consumer groups, generic drug manufacturers, antitrust experts, physicians, pharmacists, hospitals, insurers and other groups that advocate for lower-cost drugs, including: the Generic Pharmaceutical Association, AARP, the National Coalition on Healthcare, Consumers Union, Families USA, the Center on Medicare Advocacy, Public Citizen, the American College of Physicians, the American Hospital Association, the Healthcare Supply Chain Association, the National Association of Chain Drug Stores, the Pharmaceutical Care Management Association, Express Scripts, Blue Cross Blue Shield Association, the Premier Healthcare Alliance, the AFL-CIO, the American Federation of Teachers, the Public Sector Healthcare Roundtable and the UAW Retiree Medical Benefits Trust.
-30-
