AAM Applauds FDA’s Commitment to Expanding Access to Affordable Generic Medicines
WASHINGTON, DC (June 27, 2017) – The Association for Accessible Medicines (AAM) today applauded the Food and Drug Administration’s (FDA) commitment to increasing competition in the market for prescription drugs and facilitating the entry of lower-cost alternatives under its new Drug Competition Action Plan.
The FDA announced today that it will publish a list of off-patent, off-exclusivity branded drugs without approved generics, and implement a new policy to expedite the review of generic drug applications where competition is limited.
“FDA Commissioner Dr. Scott Gottlieb’s swift and decisive action to expand access to safe, effective and affordable generic and biosimilar medicines is of tremendous benefit for our nation’s patients,” said Chester “Chip” Davis, Jr., President and CEO of AAM. “Today’s announcement signals that any serious effort by the Trump Administration and the United States Congress to bring down drug costs for patients must include more affordable generics and biosimilars. AAM looks forward to working with FDA and policymakers on all possible ways to further enhance competition and improve the first cycle approval rate for generic drug applications.”
Media Contact: Justin Bartolomeo, P: 202-400-0480
AAM is driven by the belief that access to safe, quality, effective medicine has a tremendous impact on a person’s life and the world around them. Generic and biosimilar medicines improve people’s lives, improving society and the economy in turn. AAM represents the manufacturers and distributors of finished generic pharmaceuticals and biosimilars, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals are 89 percent of prescriptions dispensed in the U.S. but only 27 percent of total drug spending. Additional information is available at www.accessiblemeds.org.
About the Biosimilars Council
The Biosimilars Council, a division of the Association for Accessible Medicines (AAM), works to ensure a positive environment for patient access to biosimilar medicines. The Biosimilars Council is a leading source for information about the safety and efficacy of more affordable alternatives to costly brand biologic medicines. Areas of focus include public and health expert education, strategic partnerships, government affairs, legal affairs and regulatory policy. More information is available at www.biosimilarscouncil.org.