In a health policy landscape fraught with partisan rancor, congressional members from both sides of the aisle came together to pass the 21st Century Cures Act. Championed over the past three years by bill sponsor and House Energy and Commerce Committee Chairman Fred Upton (R-MI), the Cures Act primarily overhauls the FDA’s drug and device approval process. Secondarily, the new law provides much needed-funding to combat the opioid drug crisis, support individuals with mental illness, and advance biomedical research.
FDA Approval Process
The Cures Act is viewed as an effort to modernize the FDA’s approach to drug and device approval and emphasizes a patient-centered outlook. The legislation creates an accelerated approval pathway for drugs and devices considered to be breakthrough medical technologies in the hopes of providing life-saving treatments to those patients who currently have few options. To reduce approval time, the FDA is now authorized to use biomarkers and similar drug development tools to shorten drug development time.
The Cures Act also instructs the FDA when evaluating clinical trials to focus more on real-world evidence and “patient experience data” that provides information about the disease or treatment’s effect on patients’ lives.
On the device side, the Cures Act expands the humanitarian exemption of devices treating diseases and conditions affecting fewer than 4,000 patients to those affecting up to 8,000 patients. The FDA is also required to review and update its Class I and Class II device lists and will now need to consider only the “least burdensome” means of medical device safety prior to approval.
For combination products, the Cures Act improves the process for product approval by requiring the FDA to meet with the product sponsor during early development. Specifically, this meeting will facilitate an understanding between the sponsor and the FDA about what standard the agency will use for approval and how the sponsor should best study the product.
Finally, in an effort to increase patient autonomy, the Cures Act requires pharmaceutical companies to make their compassionate use policies publicly available, potentially increasing access to not-yet-approved drugs that have the potential to treat serious or life-threatening diseases.
The legislation also provides $500 million in additional funding to support the new goals and programs at the FDA.
Opioid Drug Crisis
The Cures Act provides $1 billion in grant money to support states trying to stem the opioid abuse epidemic. This grant money will target prescription drug monitoring programs and prevention activities, and expand access to addiction treatment.
Mental Health Funding
Considered the biggest advancement in support for mental health since the Mental Health Parity Act in 2008, the Cures Act strengthens the rules in the 2008 law, provides grant funding for psychologists and psychiatrists in an effort to increase access to mental health practitioners, and requires states to use 10 percent of their mental health block grant on early intervention.
The legislation authorizes an “assertive community treatment” grant program, which is widely considered to be one of the best courses of treatment for individuals with schizophrenia and other serious mental illnesses. It also provides funding for assisted outpatient treatment programs to support those in court-ordered care. Both programs are authorized in the Cures Act but require future congresses to appropriate the funding.
The Cures Act allows the National Institutes of Health (NIH) to finance high-risk, high-reward research projects through the creation of a special procurement process, outside the traditional NIH grants program. The legislation requires the director of the NIH to create a “EUREKA prize” competition as a way to improve biomedical research and advance treatments. Additionally, the Cures Act creates programs – including the “Next Generation of Researchers Initiative” which will improve opportunities for younger researchers – to support aspiring biomedical researchers. It also expands the scope and amount of the NIH Loan Repayment Program which reduces the student loan burden, allowing medical researchers to more easily enter public service.
The legislation authorizes $4.8 billion over 10 years to the NIH, including $1.5 billion for the Precision Medicine Initiative, $1.6 billion for brain disease research and $1.8 billion for the Cancer Moonshot Initiative that President Barack Obama announced during his last State of the Union address, which has thus far been spearheaded by Vice President Joe Biden.