You’ve probably heard about the 21st Century Cures Act, which was signed into law by President Obama Dec. 13. But, do you know what it’s all about?
The $6.3 billion law will allocate funding for research into diseases by the National Institutes of Health (NIH), and will work to increase access to mental health treatment, combat prescription drug addictions and speed up the U.S. Food and Drug Administration (FDA) approval process.
Here’s a breakdown of what the money will be used for, and how the law will affect the health care industry today—including your independent community pharmacy.
What the NIH will do
The NIH will use the majority of the money, $4.8 billion, to conduct high-risk, high-reward research using special procedures. Specifically, the organization will focus on three signature Obama administration research programs.
1. Accelerate cancer research
The Cancer Moonshot®, spearheaded by Vice President Joe Biden, is an initiative to accelerate cancer research. It aims to make more therapies available for more patients while improving the ability to prevent cancer and detect it at an early stage.
2. Increase understanding of the human brain
The Brain Research through Advancing Innovative Neurotechnologies® Initiative (BRAIN) aims to revolutionize understanding of the human brain. By filling in gaps in current knowledge about how the brain works, it will provide opportunities to discover new ways to treat, cure and prevent brain disorders.
3. Extend precision medicine
The Precision Medicine Initiative® (PMI) is an effort led by the NIH to build a national, large-scale research enterprise with one million volunteers to extend precision medicine to all diseases. Precision medicine helps treat diseases by taking into account individual variability in environment, lifestyle and genes.
Additionally, the NIH will establish the Ensuring Useful Research Expenditures is Key for Alzheimer’s (EUREKA) prize competition for advances in biomedical science and improved outcomes in treatments for serious illnesses, such as Alzheimer’s.
The takeaway: Advocates for the increase in funding noted that serious diseases, such as cancer and Alzheimer’s, take a devastating toll on patients, their families and the economy. The money will accelerate the development of new treatments, which could greatly affect the role pharmacists’ play in the lives of patients with these illnesses in the years to come.
Addressing the opioid epidemic
As the U.S. opioid epidemic continues, pharmacists are beginning to play a larger role. For example, increasing national concern has led to an upsurge in state regulations authorizing pharmacists to prescribe naloxone, an opioid overdose reversal drug.
In an effort to combat the opioid crisis, the 21st Century Cures Act is providing $1 billion to be distributed across the 50 states over the next two years for prevention and treatment programs.
The money will help the states fund medication-assisted treatment therapies to assist in curbing urges and expanding treatment options.
The takeaway: The 21st Century Cures Act will allow pharmacists to further assist patients suffering from opioid drug addictions using the new prevention and treatment program options that become available.
Combatting mental health issues
The Centers for Disease Control and Prevention (CDC) report that approximately 25 percent of all U.S. adults have a mental illness, and nearly 50 percent of U.S. adults will develop at least one mental illness during their lifetime.
Here’s how the 21st Century Cures Act will address mental health:
- Require the President to appoint a new assistant secretary for mental health and substance use to address the nation’s mental health problems
- Direct federal agencies to step up law enforcement of equal insurance for mental illness, which was recently found to be lacking despite mental health parity laws
- Authorize new treatment and prevention programs, although it won’t provide states with new resources to fund these programs
The takeaway: These new mental health initiatives should come as a relief to pharmacists, as they’re increasingly trying to find new ways to help their patients struggling with mental illness.
Speeding up the FDA approval process
The 21st Century Cures Act will allocate $500 million to the FDA over the next 10 years in an effort to speed up the approval process for drugs and medical devices.
One of the main objectives of the FDA is to pay more attention to patient experience data and real world evidence to determine patients’ preferences and the effect of diseases and treatments on their lives.
Additionally, the 21st Century Cures Act establishes new programs including the Limited Population pathway, a program to help streamline certain drug development programs intended for a limited population of patients suffering from life-threatening infections, and a program for the development of regenerative medicine products.
The FDA also plans to use the money to hire and retain scientific experts, as well as continue to improve efficiency in clinical trial design by utilizing new approaches.
The takeaway: This will allow the FDA to ensure patients get access to treatments faster, while still maintaining safety and effectiveness. Speeding up the approval process can help patients access medications they need and independent pharmacies can continue to provide the best possible care for their patients.
The 21st Century Cures Act isn’t the only legislation working to combat opioid abuse. Learn about the Comprehensive Addiction and Recovery Act (CARA).
