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Strategic Objective
Advance the regulatory sciences to enhance food safety, improve medical product development, and support tobacco regulation
Strategic Objective
Overview
Advances and innovations in regulatory science will benefit every American by increasing the accuracy and efficiency of regulatory review, and by reducing adverse drug events, drug development costs, and time to market for new medical technologies. Regulatory science also helps to prevent foodborne illnesses and limit the impact of outbreaks when they do occur. Tobacco regulatory science at HHS seeks to reduce the morbidity and mortality from tobacco use, including by preventing children and youth from ever starting to use tobacco.
Progress Update
Please note that this section summarizes the result of the FY 2014 HHS Strategic Review process, limiting the scope of content to that available prior to spring of 2015. Due to this constraint, the following may not be the most current information available.
Conclusion: Progressing
Analysis: HHS made progress in advancing regulatory science in 2014 across a broad spectrum of food safety, medical product development, tobacco regulation responsibilities. In the area of food safety, HHS established a method development, validation, and implementation program for state laboratories to ensure the highest standards of analytical laboratory practices needed to support outbreak, compliance, and surveillance testing. The Food Safety Challenge was launched in 2014 which was a prize competition to advance breakthrough in foodborne pathogen detection, with the goal of accelerating the detection of Salmonella in fresh produce. HHS created a network of 18 state and federal laboratories equipped with desktop DNA sequencers and expert staff to collect genomic data from foodborne pathogens, greatly enhancing the ability to rapidly and precisely identify patterns and isolate sources of foodborne illness.
The medical product pre-market programs are consistently meeting or exceeding their performance goals for assuring timely access to safe and effective products. More than 30 guidance documents on topics such as Biosimilarity; expedited programs for rare diseases and serious conditions; cellular and gene therapy were published. HHS responded to the Ebola Virus in a variety of ways including rapidly evaluating investigational new drug applications, enabling access to investigational products for Ebola under appropriate regulatory mechanisms, and monitoring for fraudulent products that claim to prevent or treat Ebola.
One focus area for the Tobacco Regulatory Science Program included research on the role and impact of flavors in cigarettes, cigars, e-cigarettes and smokeless tobacco. “Tobacco Use among Middle and High School Students – United States, 2011-2014” was published in Morbidity and Mortality Weekly. The article highlighted the alarming trend of e-cigarette use among high school and middle school students which increased from 4.5 percent in 2013 to 13.4 percent in 2014.
HHS will continue to investigate the impact of e-cigarette use. It is a challenge to provide scientific evidence needed to inform tobacco regulation by conducting research at a pace that can keep up with a rapidly changing tobacco product market. Recruiting and retaining a talented scientific workforce and maintaining and modernizing aging scientific facilities, field laboratories and equipment are essential to supporting such research. The Department will perform manufacturing, production, and supply chain oversight using enhanced hand-held instrumentation, remote sensing, and well as implementation of prevention controls regulation and quality system standards. In addition, collaboration on studies that address e-cigarettes use will include measuring harmful and potentially harmful constituents in e-cigarettes vapor and e-juice; addictive compound in e-cigarette vapor; and biomarkers of these harmful addictive constituents in blood and urine of users. The Department will also explore methods to improve our measures of regulatory science progress and outcomes.
