201612.20
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Many Have High Hopes for the 21st Century Cures Act

US CapitolOn December 8, Congress sent the 21st Century Cures Act to President Obama’s desk. The Act aims to fund and vastly expand medical research as well as expedite the approval of new medications and medical devices by the Food and Drug Administration. This bill enjoyed broad bipartisan support and passed the U.S. House of Representatives on an overwhelmingly favorable vote of 329-26. In the U.S. Senate, 94 senators voted for the bill. Beyond Capitol Hill, the legislation garnered support from patients, health advocacy organizations, doctors and the pharmaceutical industry.

The 21st Century Cures Act will provide $4.8 billion over 10 years to the National Institutes of Health. The highest portion, $1.8 billion, will be earmarked for cancer research. The BRAIN Initiative will receive $1.56 billion to create new technologies that will allow for comprehensive mapping of the human brain. The Precision Medicine Initiative will be granted $1.4 billion to collect genetic data from 1 million American volunteers which will be used to help develop new treatments. The remaining $1 billion with be distributed in grants among the states to address the prescription medication abuse crisis. The Act also authorizes NIH to finance high-risk, high-reward research using special procedures rather than having to navigate typical government contracts.

The FDA will have a more streamlined path to results and treatment. The Act modifies the approval pathway for antibiotics for patients facing severe and untreatable infections and will be allowed to rely on data summaries and real-world evidence when deciding if an already approved drug can be used for other purposes. FDA programs will be expanded for expedited approval of breakthrough medical technologies for patients with life-threatening diseases who have very few treatment options. Finally, the Act will help FDA hire, train and retain experienced scientists and other critical staff members.

For patients, the 21st Century Cures Act increases privacy protection for genetic research participants, improves the usability of EHRs and provides increased funding for mental health.

A wide variety of medical associations, industry lobbyists and advocacy groups have praised the action by Congress. Among these are the American Society for Clinical Oncology, the American Society of Human Genetics, the Coalition to Stop Opioid Overdose, the American Psychological Association, the American Psychiatric Association and the American Heart Association.

Physician Elaine Schattner writes in Forbes that she agrees with oncologists who feel we are at a “pivotal moment in cancer research, ready to turn in-hand progress in science and information technology into survival and quality-of-life advantages.” While some have raised concerns about changes to the FDA’s current drug approval process, others note that allowing the FDA to consider nontraditional study designs, adaptive trials, and Bayesian methods will allow the FDA to better evaluate drugs and treatments in today’s rapidly evolving world of medical research.

President Obama applauded the legislation’s final passage. “‎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. He further stated, “The bipartisan passage of the 21st Century Cures Act is an example of the progress we can make when people from both parties work together to improve the health of our families, friends and neighbors. This bill will make a big difference, and I look forward to signing it as soon as it reaches my desk.”