FDA Stakeholder Update - Friday November 9, 2018

Dear Colleague,
 
FDA’s 2018 Strategic Policy Roadmap, identified four priority areas that help further our commitment to advance public health and over the past week, FDA has had some notable news and statements that are important to highlight. The four key priority areas are:

1. Reduce the burden of addiction crises that are threatening American families
2. Leverage innovation and competition to improve health care, broaden access, and advance public health goals
3. Empower consumers to make better and more informed decisions about their diets and health; and expand the opportunities to use nutrition to reduce morbidity and mortality from disease
4. Strengthen FDA’s scientific workforce and its tools for efficient risk management

Priority Area 2: Leverage innovation and competition to improve health care, broaden access, and advance public health goals

• FDA authorizes emergency use of first Ebola fingerstick test with portable reader FDA announced an emergency use authorization (EUA) has been issued for a rapid, single-use test for the detection of Ebola virus (Zaire ebolavirus). This is the second Ebola rapid antigen fingerstick test available under EUA, but the first that uses a portable battery-operated reader, which can help provide clear diagnostic results outside of laboratories and in areas where patients are likely to be treated. Read full announcement posted on November 9, 2018
• Statement from FDA Commissioner Scott Gottlieb, M.D., and Janet Woodcock, M.D., director of the Center for Drug Evaluation and Research, on approval of OTC Primatene Mist to treat mild asthma One of our ongoing priorities is making sure consumers have access to the medicines that help keep them healthy. Part of this access includes the availability of safe and effective nonprescription, over-the-counter (OTC) medications that can help empower consumers to address medical conditions. Read full statement posted on November 8, 2018
• FDA’s MyStudies Application (App) FDA is posting computer code and a technical roadmap that will allow researchers and developers to customize and use the FDA’s newly created MyStudies app. The FDA MyStudies App is designed to facilitate the input of real world data directly by patients which can be linked to electronic health data supporting traditional clinical trials, pragmatic trials, observational studies and registries. Read full post, posted on November 6, 2018

Priority Area 3: Empower consumers to make better and more informed decisions about their diets and health; and expand the opportunities to use nutrition to reduce morbidity and mortality from disease

• Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to strengthen FDA’s expanded access program Since the 1970s, the FDA has helped to facilitate access to promising investigational medical products for patients with serious or immediately life-threatening diseases who are unable to access products through clinical trials. As a cancer survivor, I understand, on a very personal level, that patients who are fighting serious or life-threatening diseases want the flexibility to try new therapeutic approaches, including investigational medical products. Read full statement posted on November 8, 2018
• Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s effort to make more robust use of mandatory recall authority to quickly remove unsafe foods from the market Hazardous foods or potentially contaminated products can expose Americans to foodborne illness that can sometimes be life threatening. Our nation depends on the U.S. Food and Drug Administration to ensure that the foods they buy are safe. Read full statement posted on November 5, 2018
• CDRH Patient Engagement Advisory Committee On November 15, 2018, the Committee will discuss and make recommendations on the topic “Connected and Empowered Patients:  e-Platforms Potentially Expanding the Definition of Scientific Evidence.”  The recommendations will address how FDA can leverage patient-driven platforms, such as social media and registries, to better engage patients and consumers as empowered partners in the work of protecting public health and promoting responsible innovation.  Social media and other web platform enablers are facilitating the growth of virtual patient communities.  Increasingly, patients and health care consumers are using these platforms to share their health experiences and seek information from other patients and consumers, rather than their health care providers alone. Read full Advisory Committee Meeting Announcement

If you have any questions please feel free to contact our office FDAStakeholderEngagementTeam@fda.hhs.gov .