The 21st Century Cures Act, a product of months of bipartisan negotiations, was signed into law in the final days of 2016. Sponsored by Oregon Representative Suzanne Bonamici, the bill includes $1 billion dedicated to the prevention of opioid abuse and $4.8 billion to fund biomedical research. Part of the bill, called the “Beau Biden Cancer Moonshot,” in honor of Vice President Biden’s late son, dedicates $1.8 billion to cancer research. This formative legislation is divided into three major sections: discovery, development, and delivery.¹
The discovery portion of the bill reauthorizes funding for the National Institute of Health (NIH) and places an emphasis on innovative treatments for pediatric patients with various conditions. In an effort to incentivize young researchers, the government will provide student loan aid for professionals conducting qualified research. Additionally, a public registry for clinical trials will be established to facilitate collaborative work and a non-profit organization, Council for 21st Century Cures, will be created to direct research focused on preventative treatments.⁴
The development section of the act mandates the Food and Drug Administration (FDA) to create an Expanded Access Policy which will serve to allow investigational drugs, or drugs not yet approved, to be available for patients who could benefit from earlier access. Additionally, “breakthrough devices,” drugs that possibly can provide treatment but have no approved alternatives, could be given priority status during the approvals process.⁴ This section carries with it some opponents from the FDA and the science community. The bill creates a faster path for the approval of certain medications, allows antibiotics manufacturers to test in limited populations, and establishes the use of “real world evidence.”¹ The legislation defines real world evidence as “data regarding the usage, or the potential benefits or risks, of a drug derived from sources other than randomized clinical trials.”² Some argue that these aspects cater to the drug lobby and jeopardize the health of patients by cutting corners when it comes to the approvals process. Proponents of the bill cite the new approvals process as being streamlined and the use of real world evidence as an innovative way to gather information.
The primary function of the delivery part of the legislation is to establish nationwide programs to help prevent drug abuse. In order to keep up with the rapid pace of technological advancement, the bill also funds reports on the efficacy of telehealth, the distribution of health services via telecommunication technologies, such as by phone or video conferencing. To promote cost transparency for patients across the country, a public registry for the estimated payment amounts for outpatient procedures will be established.⁴
On December 13th, surrounded by lawmakers from both sides of the aisle, President Barack Obama signed the legislation into law with 12 separate pens to give out as keepsakes.¹ In a highly partisan atmosphere, the 21st Century Cures Act proves that with compromise and time, bipartisan legislation is possible.
References
1. Eilperin Juliet and Johnson Carolyn, “Obama Signs 21st Century Cures Act Tuesday,” The Washington Post, Dec 13 2016, https://www.washingtonpost.com/news/powerpost/wp/2016/12/13/obama-paying-tribute-to-biden-and-bipartisanship-signs-21st-century-cures-act-tuesday/?utm_term=.b252b71a9c8e
2. Hills Bethany and Zegarelli Benjamin, “21st Century Cures Act Requires FDA to Expand Role of Real World Evidence,” Health Law Policy Matters, Dec 19 2016, https://www.healthlawpolicymatters.com/2016/12/19/21st-century-cures-act-requires-fda-to-expand-the-role-of-rwe/
3. Hiltzik Michael, “The 21st Century Cures Act: A Huge Handout to the Drug Industry,” LA Times, Dec 5 2016, http://www.latimes.com/business/hiltzik/la-fi-hiltzik-21st-century-20161205-story.html
4. Revell Eric, “21st Century Cures: Funding Research, Development, and Delivery of New Medical Treatments,” Countable, https://www.countable.us/bills/hr34-114