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CAPD Statement on New FDA Efforts to Get Lower-cost Drugs to Market Faster


The Coalition for Affordable Prescription Drugs (CAPD), a diverse group of employers, labor unions, pharmacy benefit managers (PBMs), health plans, and state employees and retirees, today issued the following statement in response to two new guidances, issued by the U.S. Food and Drug Administration (FDA):

“Drug companies alone set the price of prescription drugs. To maintain their ability to raise prices whenever they want, drug companies manipulate the patent and regulatory process to keep lower cost competition, often from generic drugs and biosimilars, from coming to market.

“FDA’s actions today signal a willingness to take on one of the most egregious abuses employed by brand name drug companies – gaming the Risk Evaluation and Mitigation Strategies (REMS) program – in order to keep prices up and competition down. One analysis found that REMS abuse costs the health care system $5.4 billion each year.

“Along with the passage of the CREATES Act, we believe this guidance will help to ensure patients are able to access safe, effective alternatives to high-priced brand name drugs.”