The Food and Drug Administration (FDA) released a blueprint on October 6, 2010, of a plan to support and improve various aspects of "regulatory sciences" that include areas of interest to nursing education, research, and practice. The American Nurses Association (ANA) points out that regulatory science includes improved patient outcomes, informatics, nanotechnology, stem cell research, tobacco regulation, food safety, and increasing partnerships in academia and research.

Regulatory science, according to the FDA,1 includes developing tools, standards, and mechanisms for assessing safety, efficacy, quality, and performance for FDA-regulated drugs and devices. Innovations in these areas have contributed to significant improvements in pediatric health, protection against both emerging infectious diseases and terrorism, safety of the food supply, increased tobacco regulation, and the use of informatics in healthcare.

Margaret A. Hamburg, the FDA Commissioner, notes that regulatory science is the bridge between advances in science and availability of these advances for patient care. However, some FDA regulations may be more of a roadblock than a bridge. Hamburg indicates that promising therapies may be discarded during development for various reasons including a lack of current evaluation tools available to recognize treatment potentials. Hamburg also comments that outdated and ineffective FDA strategies for reviewing innovations may unnecessarily delay the approval of critical treatment strategies. FDA funding can serve to encourage academia, industry, and government officials and agencies to work together to develop more efficient strategies for regulatory science. In light of the patient safety emphasis of regulatory science, nursing faculty may want to assess the benefit of addressing regulatory science and regulatory strategies as an area for funding, education, and research.

Reference

1. FDA. Advancing regulatory science for public health. A framework for FDA's regulatory science initiative. Available at http://www.fda.gov/ScienceResearch/SpecialTopics/RegulatoryScience/ucm228131.htm. Accessed November 1, 2010. [Context Link]

Source: Carlson EE. FDA Announces regulatory science initiatives linking technology with improvements in public ealth, drugs, and devices. Capitol Update ANA. October 29, 2010:8(8). Available at http://www.capitolupdate.org/index.php/2010/10/fda-announces-regulatory-science-. Accessed October 30, 2010.

Submitted by: Robin E. Pattillo, PhD, RN, CNL, News Editor at [email protected].