21st Century Cures Act

The Cures Act that was enacted on 13th Dec. 2016 is meant to expedite the process of medical product development. It is also aimed at making it possible for new innovations in the medical field to reach the intended beneficiaries (the patients) faster. The law derives inspiration from work by FDA to include the views of patients into drug development, biological devices and products in the process of making decisions by the FDA. The ability to modernize clinical trial plans and outcome assessments; which will hasten the review of novel products in the medical field, and creation of medical counter-measures have been made possible by the Cures Act (FDA, 2017). The Act provides new authority that will assist FDA to bolster our recruitment and retention of scientific, professional and technical experts. It also initiates programs for faster development of products.

i. Economics
FDA received a major boost when the Cures Act, in Title III, authorized 500 million dollars to be channeled to its accounts for the funding of specified medical product development and innovation efforts. The National Institute of Health is also permitted by the Act to authorize funding for special cases in which there is a high probability for advancing in medical research, but is also accompanied with high risk (Thompson, 2016). Previously, it took a long process to approve funding for projects with a high risk and high reward chances.

Several other areas where about $6.3 billion is included in the Act, to be spent in the next ten year period, include:
· $1.4 billion will be allocated to the Precision Medicine Initiative. Genetic data from volunteers will be fetched to assist in the development of new medical products and treatments (Thompson, 2016)
· $1.56 billion will be allocated to the brain initiative. The project intends to map the human brain in a better way, so that a more complete understanding of its functions can be realized; thus making it possible to develop fresh treatments for the current brain maladies.
· An amount in excess of one billion will be allocated to deal with drug abuse via prescription. The funding will be extended to states that come up with new education programs for the prevention and treatment of such drug addiction and substance abuse (Thompson, 2016).

ii. Political
There are specific clauses for the creation of fresh employment chances at the United States Department of Health and Human Services, in the 21st Century Cures Act. The job positions are tailored for treatment of substance and drug abuse, mental health and research on substance abuse. The Act encourages investment of $4.8 billion in various research areas via the NIH. Cancer research got a boost in its kitty with $1.8 billion secured by former vice president Joe Biden (Thompson, 2016).
The new legislation was widely seen as a big gain by major pharmaceuticals, especially in the environment of a controversial presidential election period. The apparent important disassociation between efforts of bipartisan legislators to pass the Cures Act and the common effort to revise the Affordable Care Act was raised (Mendoza, 2017).

iii. Legal/ethical
The 21ST Century Cures Act gives FDA the legal authority to hasten the testing and approval process for new drugs, leading to faster use in pharmaceutical markets. It supports a continuous exploration process in the use of real world data. The evidence from the real world medical practice should not necessarily be different or incompatible with randomized clinical trials in the assessment of safety, and drug and device efficacy. A framework for the assessment of the risks and benefits will provide a balanced review of risks and gains, and put into practice an organized and consistent method to discussing regulatory making of decisions, relating to the risks and benefits of drugs, and the communication of the same (Mendoza, 2017). In this instance, “Foundations are also important organizations in terms of intellectual capital. They are extremely thoughtful about the areas that they fund and many times are experts in your topic so consider them partners in achieving your goals … an experienced program officer can help you improve and/or fine tune your approach” (Mason et al., 2016). Thus to achieve the objectives, several sections of Title III require drug development that is focused on patients, new therapy advancements, access to therapies and information by patients, innovations in medical devices, antimicrobial stewardship and innovation, certainty and access to vaccines (Mendoza, 2017).

References

Mason, D. J., Gardener, D. B., Outlaw, F. H., O'Grady, E. T. (2016). Policy & Politics in Nursing and Health Care, 7th Edition. ISBN 978-0-323-24144-1, St. louis, Missouri, Elsevier.

Mendoza, R. L. (2017). The 21st Century Cures Act: pharmacoeconomic boon or bane?.
Journal of Medical Economics, Vol. 20, iss. 4.

THOMPSON, D. (2016). Congress passes 21st Century Cures Act with billions for new research, treatments. CBS News. Retrieved from https://www.cbsnews.com/news/21st-century-cures-act-congress-health-care-passed/ on 19 February 2018

U.S Food & Drug Administration (FDA), (2017). 21st Century Cures Act. Retrieved from https://www.fda.gov/RegulatoryInformation/LawsEnforcedbyFDA/SignificantAmendmentstotheFDCAct/21stCenturyCuresAct/default.htm on 19 February 2018