Bill Includes Several Bennet-Backed Priorities to Reform and Modernize FDA
Washington, D.C. - The U.S. Senate today passed the 21st Century Cures Act, which includes several measures written by Colorado U.S. Senator Michael Bennet, a member of the Senate's health and education committee. The bill received bipartisan support from 94 senators.
The bill, now on its way to the President's desk to become law, is a step forward in advancing medical research and innovating drug approval so that patients have access to life-saving treatments. Bennet worked with several of his Republican colleagues on the committee to draft a number of provisions that would build on his past work to reform and modernize the Food and Drug Administration (FDA). They include strengthening research at the National Institutes of Health (NIH) and addressing the mental health crisis.
The bill includes more than $4.8 billion for the NIH and $500 million for the FDA. Bennet fought to ensure that the final bill included the funding necessary to implement key provisions. It also included $1 billion for states to combat the opioid abuse epidemic through prevention and treatment efforts.
"Researchers and life science companies in Colorado and around the country are developing new cures and treatments that can save and lengthen lives." Bennet said. "The 21st Century Cures Act, developed by both the House and the Senate, will support the research that makes those breakthroughs possible and help us save even more lives."
The 21st Century Cures Act includes the following Bennet provisions:
- The Promise for Antibiotics and Therapeutics for Health (PATH) Act, introduced with Senator Orrin Hatch (R-UT), would permit the Food and Drug Administration (FDA) to approve an antibacterial drug for a limited patient population upon determining that the drug treats a serious or life-threatening condition and addresses an unmet need. In addition, the bill includes several provisions to guide appropriate use of antibiotics approved under this pathway, such as labeling and promotional material requirements. "Superbugs"-or bacteria that are substantially resistant or unresponsive to existing and available antibiotics-are an increasingly urgent public health threat, both at home and abroad. While antibiotic-resistant bacteria kills thousands of Americans each year, less than ten new antibiotics have made it to market since 2000. Antibiotic-resistant bacteria are also a significant concern to our troops, affecting more than a third of returning Iraq and Afghanistan veterans, according to the Department of Defense.
- The Medical Electronic Data Technology Enhancement for Consumers' Health (MEDTECH) Act, introduced with Senator Hatch, takes a risk-based approach and builds upon a Food and Drug Administration Safety Innovation Act Workgroup report released earlier this year. The report was commissioned by Bennet and Hatch through an amendment to the 2012 FDA reform law. Specifically, it would clarify the FDA's role regarding regulation of administrative and financial software, wellness and lifestyle products, certain aspects of electronic health records, and software that aids health care providers in developing treatment recommendations for their patients. As the rate of innovation rapidly increases in the medical technology industry, this bill provides greater clarity to ensure that businesses understand the rules of the road so that safe and effective products reach consumers as soon as possible.
- The Advancing Breakthrough Devices for Patients Act builds on the successful "Breakthrough Therapies" pathway the Senate passed in 2012 from Senators Bennet, Hatch, and Burr. Both the 2012 legislation and the newly introduced bill share similar principles, such as an "all hands-on-deck" approach to devices targeted at serious or life-threatening conditions. It also complements and enhances the existing tools, such as priority review, currently in place for devices, with the goal of expediting the development and review of breakthrough products.
- The Mental Health on Campus Improvement Act, championed by Senator Bennet, reauthorizes a grant program for campuses and allows funding to be used for outreach and treatment of students with mental health needs. It also directs the Substance Abuse and Mental Health Services Administration (SAMHSA) and the Centers for Disease Control and Prevention (CDC) to create a public health awareness campaign around mental health and to reduce the stigma associated with mental illness for students. It would also establish an interagency working group on college mental health to discuss mental and behavioral health concerns and promote federal agency collaboration, which would support innovations in mental health services for students on college and university campuses.
- The Mental Health First Aid Act was led by Senator Bennet and Senators Kelly Ayotte (R-NH) and Richard Blumenthal (D-CT). This provision would require the Substance Abuse and Mental Health Services Administration (SAMHSA) to award grants to initiate and sustain mental health first aid training programs. These programs provide training on assisting individuals in mental health crisis to connect with appropriate behavioral health services and resources. Those who can be trained under the program include first responders, law enforcement personnel, teachers, school administrators, human resources professionals, nurses and other primary care personnel, students enrolled in school, parents of students, and veterans and veteran stakeholders.