HR 1576 — Generic Complex Drugs Safety and Effectiveness for Patients Act of 2015

1 sponsors · 0 co-sponsors · 546 not signed on

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Frequently asked questions

What does HR 1576 do?

Generic Complex Drugs Safety and Effectiveness for Patients Act of 2015 This bill requires the Government Accountability Office (GAO) to study whether generic versions of certain complex drugs or certain biological drugs face significantly different challenges in meeting the approval standards of the Food and Drug Administration (FDA) than generic versions of small-molecule drugs. (Complex drugs and biological drugs can be composed of large molecules that are more difficult to fully characterize than small molecules, so it can be more difficult to demonstrate that generic versions of these drugs are the same as the brand name versions.) If the GAO determines that these generic drugs face significantly different challenges, then the GAO must also determine: (1) the evidence that should be required to demonstrate that one of these generic drugs is sufficiently similar to the brand name drug in safety, composition, and activity; (2) whether the Federal Food, Drug, and Cosmetic Act should be amended to address the approval of these generic drugs; and (3) whether the FDA should develop a policy document on the evidence that is necessary to obtain approval of these generic drugs.

Who sponsors HR 1576?

HR 1576 is sponsored by Michael Burgess (R).

What is the current status of HR 1576?

This bill died with 114th Congress. It reached “In Committee” and never advanced before the session ended, so it can no longer move — a new version would have to be reintroduced in the current session.

Where can I track HR 1576?

Track HR 1576 free on One Click Politics — get push/email alerts when it moves.