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."
- Date added:
- Jun 26, 2012
As multidrug-resistant infections have grown more prevalent, few new antibiotics are reaching the market. This is attributed, in part, to the economic and regulatory challenges associated with their development. Recently, stakeholders have endorsed a novel regulatory pathway to approve these lifesaving drugs for use in limited patient populations — namely those at highest risk and with few or no other options.More info
''A subsidiary of India's largest pharmaceutical company has agreed to pay a record $500 million in fines and penalties for selling adulterated drugs and lying to federal regulators in a case that is part of an ongoing crackdown on the quality of generic drugs flowing into the U.S."More info