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The 21st Century Cures Act: A Scientific Revolution

by Jill McDonnell

Political turmoil in contemporary media coverage has overshadowed one of the most impactful bipartisan efforts to expand scientific research. In December 2016, the Obama Administration signed the 21st Century Cures Act into law, allocating $4.6 billion in funding to the National Institutes of Health (NIH). Altogether, the law aims to expand medical research and speed up the development and approval of new drugs and treatments.

Of the total $4.6 billion granted, $1.8 billion supports former Vice President Joe Biden’s Cancer Moonshot initiative to boost cancer research, which he started after his son Beau passed away due to brain cancer in May 2016. An additional $1.6 billion is reserved for the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative, which hopes to map the human brain and seek treatments for neurological disorders, such as Alzheimer’s Disease. The Food and Drug Administration (FDA) will receive $500 million to speed up drug approval, and the remaining $1 billion will go to state grants to fight the opioid epidemic. Furthermore, the Precision Medicine Initiative will receive federal funding to support its innovative endeavors using patients’ genetic and molecular profiles to design customized drugs and therapies tailored to each patient’s individual needs.

On top of these pushes for cutting-edge scientific research, the law has an additional focus on pediatric medicine. Under these new legislative conditions, the NIH must provide workshops with a community of experts to discuss age-related restrictions in clinical trials and publish the number of children in their studies. Based on these cooperative values, a “global pediatric network” is encouraged for researchers all over the world to share information on pediatric diseases.

Likewise, collaboration among researchers from all fields is highly encouraged. For example, all NIH data must now be standardized and uploaded to a clinical trial data bank. This statistical integration will allow scientists to combine their knowledge, and ultimately speed up the discovery of new information. In order to boost this emphasis on information sharing, established privacy laws will be edited to allow researchers less restricted access to patient data.

Furthermore, the law mandates an expansion of role of the FDA by creating a procedure to measure the quality of drug-development processes, examining components, such as ingredients, methods and measurement tools. Also, the FDA now has special permission to speed up a drug’s approval if needed for “serious or rare conditions” and must establish “a program for priority review of breakthrough medical devices.” Along with its revised drug research ambitions, the FDA will set stricter regulations on antibiotic use and create a way to identify the susceptibility of drugs to become antibiotic-resistant. New vaccine reviews must be expedited, and the Centers for Disease Control and Prevention must provide vaccine developers with public health data upon request.

The law also contains the largest mental health reforms since the Affordable Care Act (ACA) was enacted in 2010. The newly-created Assistant Secretary position within the Substance Abuse and Mental Health Services Administration (SAMHSA) will serve to coordinate mental health programs across the United States. Additionally, the Secretary of Health and Human Services (HHS) will provide clearer guidelines on when patient data can be shared among providers and families. Monetary grants aim to relieve the short supply of psychologists and psychiatrists, and early intervention for psychosis with the expansion of outpatient treatment centers will improve care for children and adults with serious mental illnesses. While mental health advocates are very pleased with these provisions, Senator Chris Murphy (D-Conn) says that Medicaid cuts, and especially a repeal of the ACA, would undermine any mental health progress from this law.

Overall, current and future scientists largely benefit from the 21st Century Cures Act. For instance, students studying to become research scientists will now have access to a new loan-repayment program. More federal grants in the form of Capstone Awards can be requested from the NIH for specific research projects, and the NIH is required to reduce the administrative burden on NIH-funded researchers. Lastly, clinical researchers no longer have to obtain informed consent from patients if the testing poses virtually no risk, saving both scientists and patients time and paperwork.

The bill was overwhelmingly supported in both the Senate (94-5) and the House of Representatives (392-26). Those who opposed the bill say it gives far too much power to an already dominant pharmaceutical industry. Many still fear that a less-regulated drug approval process would rake in money for pharmaceutical and medical device companies, while potentially imposing a danger to patients who receive treatments that have not yet been closely inspected. At the same time, many Democrats also contested the deregulation of the FDA, but agreed to vote for the bill if coupled with additional NIH funding.

Still, by opening long-closed doors for research and development, many hail the 21st Century Cures Act as a catalytic game-changer in the field of science. Only time will reveal how the new legislation will unfold under President Donald Trump’s leadership and its positive and negative outcomes on patients, providers and industries, but one thing is for certain: science is undergoing a massive revolution.