Pew Commends Congress for Passing FDA User Fee Legislation

WASHINGTON—The U.S. Senate today joined the House in passing Food and Drug Administration Safety and Innovation Act (S. 3187), a bill to support the U.S. Food and Drug Administration's drug and device reviews.

"We commend the Senate for passing the bipartisan FDA Safety and Innovation Act, and the Health, Education, Labor and Pensions Committee for its leadership throughout this process,” said Allan Coukell, director of medical programs at the Pew Health Group.

"This legislation will, for the first time, enable the FDA to:

• Regularly inspect foreign drug manufacturing facilities, which supply 80 percent of the ingredients in our medications
• Spur the development of new antibiotics specifically to treat serious and life-threatening infections; and
• Actively monitor the safety of high-risk medical devices already on the market and promote innovation by streamlining the review process for new low- and medium-risk devices.

"We applaud Republicans and Democrats in both chambers of Congress for collaborating with each other and with businesses, consumer and patient advocates, and the medical community to develop and pass this bill. We now urge President Obama to sign and implement this legislation as swiftly as possible."