As one of President Obama’s final acts in office, on December 13, 2016, he signed into law the 21st Century Cures Act. The Act, which is a wide-reaching piece of legislation, provides $6 billion in funding to “invigorate medical research, promote innovation, and speed the development of new treatments.” There are five areas of health care research affected by the 21st Century Cures Act: the opioid epidemic, mental health, drug innovation, cancer research, and Alzheimer’s research.
In the last fifteen years, more than 500,000 people died from opioid overdoses (including both opioids and heroin). The CDC believes, among other prevention tactics, state strategies for preventing opioid overdose need to be implemented and strengthen. The 21st Century Cures Act does just that. The Act appropriates $1 billion to fight the nation’s growing opioid epidemic. The money will go to “state efforts such as making treatment programs more accessible, training healthcare professional to better care for people dealing with addiction, and conducting research into the most effective approaches to prevent dependency.” The Act will enable greater access to treatment and prevent opioid addictions and overdoses.
The 21st Century Cures Act also aims to boost mental health policies through broad efforts that address suicide prevention and mental illness throughout the nation. Critics argue, however, that the Act provides little aid to individuals actually suffering from mental illness. The Act creates the new positions of Assistant Secretary for Mental Health and Substance Use Chief Medical Office, which are intended to “strengthen mental health leadership.” The Act also creates the Interdepartmental Serious Mental Illness Coordinating Committee to, among other responsibilities, determine what impact federal programs have on the rates of suicide and substance overdoses, as well as the prevalence of mental illness. Further, the Act fixes the so called “Medicaid Same-Day Billing Glitch,” which in essence prevented patients from seeing both a primary care physician and mental health professional on the same day because Medicaid only permitted the billing of one health care provider per day. The Act also improves mental health treatment in a variety of ways: improving mental health parity enforcement; creating early intervention programs; making available assisted outpatient treatment and assertive community treatment as well as creating a suicide prevention technical assistance center.
The Act’s objective was to “inject more flexibility” into the FDA approval process for drugs and medical devises. Developing and introducing a new drug to the market costs an estimated $2.558 billion and takes, on average, twelve to sixteen years. For approval, drug sponsors must submit substantial evidence of the drug’s efficacy, safety, and quality—hence the reason behind all the costly and lengthy clinical trials. The Act, however, provides drug sponsors with increased flexibility.
It does so by allowing drug sponsors to submit “data summaries,” which could include previously submitted data for the same chemical compound, real world evidence, anecdotal evidence, insurance data, observational data, and in-house data, as evidence of efficacy, safety, and quality. In a way it makes sense—why make drug sponsors spend millions of dollars to produce data they already have? Proponents of the Act claim that by decreasing the amount of time and money drug sponsors spend on research and development, more drugs will enter the market. Additionally, at least theoretically, drug developers can lower the price of drugs because they have less money to recoup from the R&D. Whether they actually do so remains to be seen.
There are, however, many critics concerned on whether the use of data summaries undermines the FDA’s authority and will allow unsafe drugs to enter the market. As Jennifer MacCormack points out, “medical devices and pharmaceuticals are still subject to federal oversight.” The Act does not give drug sponsors carte blanche when it comes to drug approvals; drug sponsors will still be required to affirmatively show the efficacy, safety, and quality.
In 2015, Vice-President Joe Biden, whose own son died of brain cancer, spearheaded an initiative called the “Cancer Moonshot.” The initiative provided federal and private funding to accelerate cancer research and hopefully find the cure to cancer. With the transition of President Trump, the future of the initiative was uncertain; however, the 21st Century Cures Act reserves $1.8 billion for the initiative, thus ensuring the Cancer Moonshot sticks around for a little longer.
A decade of research focusing on finding a cure for Alzheimer’s has proven ineffective. We do not have even one treatment. There is an acute need to focus research on developing treatments or cures for Alzheimer’s—especially when you consider that Alzheimer’s could cost the country upwards of $20 trillion as Baby Boomers get older. In order to accelerate treatment discovery, the Act provides $1.6 million in funding to President Obama’s BRAIN research initiative, which tackles Alzheimer’s, dementia, and several other brain diseases. The funding will go “toward research, with the goal of finding effective interventions to treat or prevent Alzheimer’s or related dementias by 2025.”
The 21st Century Cures Act, which passed both houses of Congress with overwhelming support, is tackling some of the nation’s largest health issues and it seems pretty clear that the Act will play an important role in the development of new treatments in the coming years.
Kathryn Brown is a May 2017 J.D. candidate at DePaul University College of Law. Kathryn is the Managing Editor of Lead Articles for DePaul Law Review, a Fellow and Co-Director of Programming for the Jaharis Health Law Institute, and an Editor and Staff Write for the Institute’s online publication, E-Pulse.