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Press Release
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."
The Pew Charitable Trusts and the Premier healthcare alliance sent the White House Office of Management and Budget a letter regarding the review of a Food and Drug Administration rule to establish a unique device identifier (UDI) system. Given the importance of this new device identification system to improve patient care and the missed statutory deadline, in this correspondence Josh Rising of Pew and Blair Childs of Premier strongly urged the Director of the Office of Management and Budget (OMB) to promptly complete review of the UDI final rule.
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Nearly a year after the enactment of the Generating Antibiotic Incentives Now Act, the U.S. Food and Drug Administration has released draft guidance for industry on developing antibacterial therapies for patients with unmet medical needs.
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A letter from Josh Rising — director of Pew's Medical Device Initiative — to The White House Office of Management and Budget, requesting a speedy review of regulations to develop a unique device identifier (UDI) system.
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