Murray Helps Pass FDA Revitalization Bill that Overhauls Drug Safety and Effectiveness

(Washington, D.C.) – Today, U.S. Senator Patty Murray (D-WA) voted to make major improvements to the Food and Drug Administration (FDA) by approving S.1082, the FDA Revitalization Act. The bill takes critical steps to improve FDA drug safety, transparency, pediatric pharmaceuticals, and ensures a timely drug review process. The Senate passed the bill by a vote of 93-1.

“The American public deserves nothing less than the gold standard of care from the FDA,” said Senator Murray. “When a nervous parent or a weary senior visits their corner pharmacy they deserve to know that the products on those shelves have been approved by a thorough and complete process. This legislation delivers greater safety while also providing better access. I believe that it will improve the way we deliver safe, innovative healthcare in America, and it’s my hope that it will also begin to restore confidence in the institutions that safeguard the public’s health.”

Specifically, S1082:

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  Reauthorizes and improves both the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee and Modernization Act (MDUFMA) which are critical in providing a timely drug review process.
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  Strengthens science at the FDA and improves transparency.
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  Improves oversight and information about clinical trials.
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  Creates a new system to actively monitor drugs after they’ve been approved by the FDA.

The legislation seeks to improve post-market safety in light of recent news concerning public exposure to the dangerous side effects of some antidepressants and the arthritis drug Vioxx.

“I was shocked at the recent revelations concerning drugs that posed risks to public safety but remained on the market for far too long,” Murray said “This bill addresses that problem by instituting strong new protections including post-market studies that will be publicly available. I believe that this new transparency and vigorous oversight is the path toward restoring public confidence in the FDA.”

The FDA Revitalization Act also extends and improves several programs that bolster pediatric care. Those programs include:

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  The Best Pharmaceuticals for Children Act which ensures pediatric medicine is a priority and that information on pediatric drugs is readily available.
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  The Pediatric Research Improvement Act which provides needed safety measures through mandatory clinical trials.
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  The Pediatric Medical Devices Safety and Improvement Act which uses incentives and investor outreach to ensure that exciting advances in life saving medical devices are not limited to adults.

“Every year, we see incredible technological breakthroughs in drugs and medical devices. However, sometimes those improvements do not account for the needs of children and the pediatricians who treat them,” said Senator Murray. “This bill uses incentives and regulations to put America’s children first.”

Read Senator Murray’s floor speech on the FDA Revitalization Act.