WASHINGTON—President Barack Obama today signed into law the Food and Drug Administration Safety and Innovation Act, which supports the U.S. Food and Drug Administration’s drug and device reviews and includes other measures to benefit patients.
"By signing the FDA Safety and Innovation Act, President Obama has ensured that the FDA will have the resources and authority it needs to promote the development of safe, effective and innovative medical products that Americans need," said Allan Coukell, director of medical programs at the Pew Health Group.
"This Administration should recognize the broad, bipartisan support this bill has earned and implement it without delay."
Public health and consumer advocacy groups are attacking Senate legislation designed to tighten oversight of specialized pharmacies such as the one at the center of this past fall’s deadly meningitis outbreak, saying it does not adequately address health risks.
More infoAs 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.
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