Aside from all the bickering we have experienced among all political parties over the years, The 21st Century Cures Act, a bill signed into law on December 13th 2016, is a brilliant piece of nonpartisan legislation that promotes innovation and holds promise for huge advancements in the clinical research space, which will lead to bettering healthcare for millions worldwide. The excitement behind this bill is in large part due to the nearly $4.8 billion designated to the NIH for biomedical research including high-risk research and early phase studies. The bill will also provide an additional $500 million in new funding to the FDA to aid in advancements to regulating the rapidly evolving research industry.
This means more funding and opportunities for researchers, more business for CROs, and more advancements towards bettering the lives of those battling cancer, brain diseases and rare diseases. Portions of the $4.8 billion designated to the NIH will go to Precision Medicine Initiative, BRAIN Initiative, Cancer, and Adult Stem Cells research. The bill also offers an education repayment program for emerging scientists in exchange for research work in emerging fields.
FDA regulations will experience changes as a result of this bill as well. One change can be found in Subtitle A under Title II of the bill, patient-focused drug development. This section amends the Federal Food, Drug, and Cosmetic Act to require the FDA to establish new processes, which allow real world patient data to be considered in the risk-benefit assessment of a new drug. Changes like these will help to advance research on rare diseases that do not have a large pool of study participants to draw from.
To learn more about this bill and how it will create waves among our industry for years to come you can visit the following links: