S. 2683: AMERICAN DRUGS Act

This bill generally limits coverage of generic drugs under federal health care programs to those that are manufactured domestically.

Specifically, the bill prohibits coverage of generic drugs that are manufactured in foreign countries under Medicare, Medicaid, the Children's Health Insurance Program (CHIP), TRICARE, and benefits provided by the Veterans' Administration. Coverage is permitted for foreign-made generic drugs if there are fewer than two other generic versions that are manufactured domestically or if the generic versions that are manufactured domestically are in shortage or soon to be discontinued. The Food and Drug Administration (FDA) must notify appropriate agencies about brand-name drugs that have at least two generic versions that are manufactured domestically and those that do not.

The bill also allows the FDA to expedite the development and review of applications for generic versions of brand-name drugs that do not have at least two generic versions that are manufactured domestically.

Written by the Congressional Research Service, Library of Congress.