Topics on this page: Goal 2. Objective C | Table of Related Performance Measures | Analysis of Results | Plans for the Future | Objective Progress Update Summary
Goal 2. Objective C: Advance the regulatory sciences to enhance food safety, improve medical product development, and support tobacco regulation
Regulatory science is the development and use of scientific tools, standards, and approaches necessary for the assessment of products including medical products and foods to determine safety, quality, and performance. Without advances in regulatory science, promising therapies may be discarded during the development process simply for the lack of tools to recognize their potential; moreover, outmoded review methods can delay approval of critical treatments. Advancements in regulatory science will help to prevent foodborne illnesses, and when outbreaks of foodborne illness occur, to identify the source of contamination quickly and to limit the impact of the outbreak. Regulatory science innovations will allow for faster access to new medical technologies that treat serious illnesses and improve quality of life. These advances will benefit every American by increasing the accuracy and efficiency of regulatory review and by reducing adverse health events, drug development costs, and the time-to-market for new medical technologies.
Advancing regulatory science and innovation is an objective shared by a number of agencies within HHS. FDA and NIH are collaborating on an initiative to fast-track medical innovation to the public. Below are several performance measures that are indicative of the types of achievements that HHS and its components expect to achieve related to improving regulatory science and food and medical product safety. The Office of the Secretary led this Objective’s assessment as a part of the Strategic Review.
Objective 2.C Table of Related Performance Measures
The average number of days to serotype priority pathogens in food (Screening Only). (Lead Agency - FDA; Measure ID - 214306)
| FY 2011 | FY 2012 | FY 2013 | FY 2014 | FY 2015 | FY 2016 | |
|---|---|---|---|---|---|---|
| Target | 9.0 working days | 6.0 working days | 5.0 working days | 4.0 working days | 4.0 working days | 3.0 working days |
| Result | 7.0 working days | 6.0 working days | 5.0 working days | 4.0 working days | Dec 31, 2015 | Dec 31, 2016 |
| Status | Target Exceeded | Target Met | Target Met | Target Met | Pending | Pending |
Complete review and action on original New Animal Drug Applications (NADAs) and reactivations of such application received during the fiscal year. (Lead Agency - FDA; Measure ID - 243201)
| FY 2011 | FY 2012 | FY 2013 | FY 2014 | FY 2015 | FY 2016 | |
|---|---|---|---|---|---|---|
| Target | 90% w/in 180 days | 90% w/in 180 days | 90% w/in 180 days | 90% w/in 180 days | 90% w/in 180 days | 90% w/in 180 days |
| Result | 100% w/in 180 days | 100% w/in 180 days | Jan 31, 2015 | Jan 31, 2016 | Jan 31, 2017 | Jan 31, 2018 |
| Status | Target Exceeded | Target Exceeded | In Progress | Pending | Pending | Pending |
Develop biomarkers to assist in characterizing an individual's genetic profile in order to minimize adverse events and maximize therapeutic care. (Lead Agency - FDA; Measure ID - 262401)
| FY 2011 | FY 2012 | FY 2013 | FY 2014 | FY 2015 | FY 2016 | |
|---|---|---|---|---|---|---|
| Target | Identify target genes that can predict potential for obesity and type 2 diabetes to provide individually tailored therapeutic treatment and dietary guidelines for use in improving health | 1) Develop analytical methods to assess drug-induced heart damage 2) Identify target genes for obesity and the consequent development of metabolic syndrome diseases and heart disease | 1) Analyze urine, blood , and tumor tissues samples to identity biomarkers that will facilitate early detection in new cases and in the reemergence of pancreatic cancer. 2) Develop a new targeted therapeutic approach to improve clinical management of breast cancer. | Determine if some drugs cause a higher incidence of liver toxicity in women than men | 1) Complete pilot project that will promote women’s health by facilitating the development of personalized approaches to treat breast cancer 2) Evaluate serum metabolic biomarkers to determine whether they are correlated to acute kidney illness diagnosis and prognosis |
Identify potentially predictable drug/drug receptor combinations that can cause rare and unpredictable side effects |
| Result | Statistical analyses of gene-phenotype interactions and nutrient levels were conducted and target genes identified, further results are pending a final analysis and publication (Target Met) | 1) A model of drug-induced heart damage was developed and is being used to identify new predictive biomarkers of early stages of drug-induced cardiac tissue injury. (Target Met) 2) Research experiments have been completed and preliminary results suggest the involvement of a number of genes involved in lipid metabolism and sugar transporters. (Target Met) |
Published results that found potential for new breast cancer therapy using epigenetic approach (Target Met) | Researchers found that 18 out of 30 previously identified drug transporter genes exhibited sex differences in normal kidney tissue. Ethnicity and age also influenced gene expression levels in normal kidney tissue. | Dec 31, 2016 | Dec 31, 2017 |
| Status | Target Met | Target Met | Target Met | Target Met | Pending | Pending |
Analysis of Results
HHS supports an extensive set of efforts to protect and promote food and medical product safety. FDA Foods Program scientists are evaluating commercially available instrumentation that can be adapted to support the FDA mission to prevent foodborne illnesses. The Center for Food Safety and Applied Nutrition has advanced two of these technology platforms to Field laboratories. The instrumentation is laboratory-based and provides broad-range and strain-specific identification of infectious organisms for multiple applications (clinical and environmental). These detection platforms are enhancing FDA regulatory activities and shortening FDA response time during foodborne outbreaks involving Salmonella. In FY 2014, FDA met the target of reducing the average number of days to serotype priority pathogens in foods to four working days.
The Animal Drug User Fee Act (ADUFA) helps FDA ensure that new animal drug products are safe and effective for animals as well as for the public with respect to animals intended for food consumption. FDA pursues a comprehensive set of review performance goals and commitments that seek to improve the timeliness and predictability of the review of new animal drug applications (NADAs). In FY 2012 FDA exceeded its ADUFA performance goal for the tenth year in a row, completing review and action on 100 percent of original NADAs.
The National Center for Toxicological Research’s goal is to define the correlations between an individual’s nutrition, genetic profile, health, and susceptibility to chronic disease in support of personalized nutrition and health. This research will provide baseline data that supports the FDA goal of providing consumers clear and timely information to help promote personalized nutrition and health. Identifying biomarkers of health, susceptibility to chronic disease, and gene-micronutrient interactions is essential to gaining a more complete scientific understanding of health. NCTR is implementing a novel research program for personalized nutrition and health that relies on the “challenge homeostasis” concept for identifying markers of health and susceptibility. Since 2008, FDA/NCTR and USDA/ARS have had an ongoing partnership with a community development center in the Mississippi Delta region of Arkansas to conduct community-based participatory research (CBPR) that studies the effects of dietary intake and its influence on the development of obesity-associated diseases. This ongoing collaboration analyzes dietary intake patterns, micronutrient levels in the blood samples of children and adults, and calories expended. In FY 2014, the FDA met its goal as its researchers found that 18 out of 30 previously identified drug transporter genes exhibited sex differences in normal kidney tissue.
Plans for the Future
The FDA plans to continue to coordinate testing and refinement of the technology to reduce the average number of days to identify pathogens in food. This technology has already reduced the time to conduct these analyses from 14 days to less than a week, with future targets indicating even less time. The FDA intends to maintain its goal of review and action on 90 percent of original New Animal Drug Applications within 180 days. In addition, the FDA plans to study if some drugs cause a higher incidence of liver toxicity in women than men. HHS will explore the possibility of adding additional performance measures to this Objective with the goal of capturing a broader representation of the Department’s activities.
Objective Progress Update Summary
HHS demonstrated progress toward this objective as shown by the representative performance measures described in the HHS Annual Performance Plan and Report. Further evidence of progress is described below.
- In 2013, the CDC's Outbreak Response and Prevention Branch monitored approximately 35 potential food poisoning or related clusters each week, and investigated more than 220 multistate clusters of illness. These investigations led to the identification of 50 confirmed or suspected vehicles of transmission, and with the support of the FDA, led to the recalls of a variety of foods including frozen pizza snacks, salads, chicken, ground beef, and tahini sesame paste.
- As part of an on-going interagency partnership, the NIH and the FDA have created 14 new Tobacco Centers of Regulatory Science (TCORS) designed to generate research to inform the regulation of tobacco products to protect public health. Taken together, the TCORS sites will increase knowledge across the full spectrum of basic and applied research on tobacco and addiction. The program also provides young investigators with training opportunities to ensure the development of the next generation of tobacco regulatory scientists.
