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December 8, 2016

21st Century Cures Act Heads for Obama Signature After Senate Approval

  • The 21st Century Cures Act is heading for signature into law by President Barack Obama, following its passage yesterday by the U.S. Senate in another lopsided bipartisan vote.

    The 94 to 5 Senate vote came a week after 21st Century Cures overwhelmingly passed the U.S. House of Representatives by 392 to 26. Senate passage was all but assured on Monday when the Senate, with Vice President Biden presiding, approved by 85 to 13 a procedural “cloture” vote ending debate on the measure.

    Senators voting against 21st Century Cures yesterday were Mike Lee (R-UT), Jeff Merkley (D-OR), Bernie Sanders (D-VT), Elizabeth Warren (D-MA), and Ron Wyden (D-OR).

    Sanders and Warren had spoken out publicly against the bill, asserting that it overly favored the interests of biopharma giants over patients and should have included provisions to contain rising prescription drug prices.

    Echoing that view was a public advocacy group critical of the pharmaceutical industry, Public Citizen: “It is sorely disappointing that Congress gave Big Pharma and the medical device industry an early Christmas present,” Michael Carome, M.D., director of Public Citizen’s Health Research Group, said in a statement.

    Research advocates and industry groups, however, praised the Senate vote and the prospect of the Cures Act becoming law, saying the measure will help speed up approval of new drugs and maintain U.S. leadership in research, while tackling a host of disease and health priorities ranging from cancer to the opioid epidemic.

    “The bill is a crucial step toward removing barriers to innovation, securing funding for major initiatives like the Cancer Moonshot, and streamlining drug development to ensure more patients benefit more quickly from lifesaving therapies and devices,” Research!America president and CEO Mary Woolley said in a statement.

    While praising most of the amended Cures Act, Research!America took issue with Congress’ paying for the legislation in part by holding off on future increases in the Prevention and Public Health Fund—created through the  Affordable Care Act to fund programs designed to improve health outcomes and enhance healthcare quality—saying the decision “will inevitably impact efforts to address health threats.”

    Sara Radcliffe, President & CEO of the California Life Sciences Association, hailed the legislation as “a landmark, bipartisan package of innovative reforms that will help propel the U.S. life sciences research, investment, and innovation ecosystem, benefiting patients here and around the world for many years to come.”

    21st Century Cures includes $4.8 billion for the NIH toward three Obama administration research efforts: The “Cancer Moonshot” headed by Vice President Joe Biden ($1.8 billion), the BRAIN initiative (Brain Research through Advancing Innovative Neurotechnologies) ($1.6 billion), and the Precision Medicine Initiative ($1.4 billion). Also in the bill is $500 million over 10 years for the FDA, intended to help it fill 600 vacant positions and implement a streamlined review process for combination drug-device products and other rules aimed at accelerating reviews of new drugs.

    Under the Cures Act, FDA would be allowed to support approval of a new indication for a previously approved drug by evaluating “real world” evidence from clinical experience in place of evidence from clinical trials, and to establish a streamlined data review program.

    The bill will also require the FDA to include a statement regarding any patient experience data that was used at the time a drug is approved. Patient experience data is defined as “data collected by any persons (including patients, family members, and caregivers of patients, patient advocacy organizations, disease research foundations, researchers, and drug manufacturers).” The FDA would be required to issue guidance on how patient experience data is to be collected.

    “We are now one step closer to ending cancer as we know it, unlocking cures for diseases like Alzheimer’s, and helping people seeking treatment for opioid addiction finally get the help they need,” President Obama said yesterday in a statement after the Senate vote.

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