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From Health Law Daily, December 8, 2016

21st Century Cures Act headed for President’s desk

By Bryant Storm, J.D.

The Senate passed the 21st Century Cures Act with a 94 to 5 vote, continuing the trend of bipartisan support which brought the bill through the House on a 392 to 26 vote. President Obama—whose signature will write H.R. 34 into law—praised the bipartisan lawmaking, saying "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." He noted, "I look forward to signing it as soon as it reaches my desk."

General provisions. The Cures Act intends to make good on the promise of its name through FDA reforms, new administrative positions related to mental health and substance abuse, and state funding to combat opioid addiction (see 21st Century Cures Act clears House, now set for Senate vote, December 1, 2016).

FDA. The legislation will expedite FDA approval of new drugs through the infusion of $500 million in funds to hire more FDA staff to review drug applications. The FDA reform will include: expedited review for breakthrough devices, increased patient involvement in the drug approval process, a streamlined review process for combination products that are both a drug and device, and freedom from red tape for software (see Faster, please: expedited drug approval pathways increasingly popular, July 2, 2015).

Other provisions. The Cures Act provides additional investments regarding substance abuse and innovation: $1 billion towards the opioid crisis; $1.8 billion in new resources to accelerate discoveries in cancer research; and $3 billion to build upon the BRAIN and Precision Medicine initiatives which are focused on diseases like Alzheimer’s. The Cures Act also includes the development of the Mental Health and Substance Use Disorder Parity Task Force.

Opposition. Although the bill passed the House and Senate with bipartisan support, some senators opposed the health care package. Sens. Elizabeth Warren (D-Mass) and Bernie Sanders (I-Vt), who were among the five senators who voted "Nay," expressed opposition the Cures Act on the grounds that it includes too many concessions to the pharmaceutical industry and does not guarantee enough in the way of substance abuse and medical research funding.

Support. Senate Health Committee Chairman Lamar Alexander (R-Tenn) called H.R. 34 "the most important bill of the year." President Obama noted, "like all good legislation, [the bill] reflects compromise" and expressed his support for the bill, saying, "we should seize every chance we have to find cures as soon as possible."

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