Lower Drug Costs through Competition Act

As part of the Food and Drug Administration’s mission to protect the public health, the Food and Drug Administration approves generic drugs that help establish competitive markets for treatments that improve the lives of millions of patients in the United States.

Rising health care costs, including prescription drug costs, continue to be a major concern for patients in the United States.

Eighty-eight percent of prescription drugs dispensed in the United States, or nearly 9 out of every 10 prescriptions dispensed, are generic drugs.

Studies suggest that generic drugs account for only 28 percent of total prescription drug spending and were responsible for $1,680,000,000,000 in estimated savings over the period of 2005 to 2014.

Increasing generic competition can be an effective way to help keep prescription drug costs low for patients, the health care system, and Federal and State government.

While the Food and Drug Administration has made progress toward a more consistent timeline for generic drug approvals since the enactment of the Generic Drug User Fee Amendments of 2012 (21 U.S.C. 379j–41 et seq.), a significant backlog of abbreviated new drug applications for generic drugs remains.

The sudden, aggressive price hikes for a variety of recently acquired off-patent drugs that have been used widely for decades, for which there is no generic drug competitor, also affects access to affordable prescriptions for patients and the overall cost of health care in the United States.

Improving the review of abbreviated new drug applications and the approval of generic drugs would help to improve competition and lower prices for patients.

Establishing a clear timeframe for the Food and Drug Administration to expedite the review of certain applications for generic drugs would also help keep drug prices down and improve timely access for patients.