Senate Passes FDA Safety and Innovation Act

June 27, 2012

On June 26, 2012, the Senate passed the Food and Drug Administration (FDA) Safety and Innovation Act (S.3187) by a vote of 92 to 4. The bill revises and extends the user-fee programs for prescription drugs and medical devices, and establishes user-fee programs for generic drugs and biosimilars. Furthermore, the legislation aims to modernize FDA authority and improve patient safety. The bill includes a requirement that commercial drug importers register with the Department of Health and Human Services. Commercial drug importers may also be required to submit additional compliance information. The industry user fees included in the bill are expected to fund a part of the FDA’s review of drugs and medical devices.

The FDA Safety and Innovation Act will now be sent to the President, as the House already passed the bill on June 20, 2012.

For further information, please continue to visit www.barnesrichardson.com or contact a Barnes/Richardson attorney.