Perhaps one of the most significant pieces of legislation signed by President Obama is the 21st Century Cures Act, a bill enacted a little over a month before his departure from office. In terms of furthering health and wellness, the 21st Century Cures Act makes it easier for the Food and Drug Administration (FDA) to accelerate drug approvals.
The FDA is a longtime advocate of this change, having voiced its support in a statement by Director Janet Woodcock, M.D., in which she says: "FDA welcomes the opportunity to constructively engage and work with Congress and stakeholders in an effort to improve review efficiency and effectiveness while maintaining the high safety and efficacy standards for which FDA approval has become the global 'gold standard."
Specifically, the 21st Century Cures Act allocates $500 million to the FDA to move drugs and devices to patient customers faster. It offers $4.8 billion to the National Institutes of Health (NIH) to initiate and expedite research on the Precision Medicine Initiative and Brain Research through Advancing Innovative Neurotechnologies (BRAIN), a regenerative form of medicine using adult stem cells and cancer research.
While earmarking $1 billion in grants to individual states to improve opioid abuse prevention and treatment, the 21st Century Cures Act also requires the FDA and Centers for Disease Control and Prevention (CDC) to gather, analyze and report data on human resistance to antimicrobial drugs.
That decision, however, creates limited pathways for seriously ill patients to pre-approved antimicrobial drugs. Additional orders include having the Government Accountability Office (GAO) review patient access to health information, such as barriers to access and complications involving healthcare.
According to Hoala Greevy, Founder and CEO of Paubox: "The biggest hurdle for entrepreneurs will be understanding the pace of the healthcare industry. Most entrepreneurs move fast, and it can be frustrating at times to enter a space that takes a while to get going. But there's a lot of opportunity and benefit if you can be patient and take the time to learn how things work."
Entrepreneurs have many chances to meet and join the discussion about what the 21st Century Cures Act means in theory and practice.
Consider the following events:
- Software Design for Medical Devices Europe will meet in Munich, Germany, on February 21-24, 2017. Panels and speakers will work on the Medical Device Single Audit Program, the nature of the Root Cause Analysis and the clarification of new FDA policies and practices.
- Medical Devices 10X Medical Device Conference will meet in San Diego, California, on May 1-3, 2017. Participants will follow an agenda on preparing for an FDA pre-submission and on health economics and revised reimbursement on home-infusion protocols.
- The 3rd Annual ComplianceOnline Medical Device Summit meets in Boston, Massachusetts, on June 8-9, 2017 to focus on sorting out the implications and outcomes of the Cures Act. Among others things, FDA Directors will report and discuss the futures of medical device regulation and risk management.
There is also Atlanta's Global Center for Medical Innovation (GCMI), a not-for-profit consortium of members representing universities, research centers, and practitioners. By reviewing the benefits for entrepreneurs, from increased speed of delivery of products to market to expanded funding for research to enhanced data analytics to better access for patients in need of care, the Act is a catalyst for innovation and commercial success.
This bill is far from flawless, but it is a chance to elevate the importance of personal health and corporate wellness. With a commitment to collaboration, and with a pledge to help those most in need of assistance, the 21st Century Cures Act can inspire a new wave of entrepreneurialism within the healthcare industry.
About the Author
Andre Bourque is a writer and analyst, covering healthcare, technology, business and entrepreneurship, among many other things. Based in Southern California, he is a frequent commentator about economic and social trends.