FDA Stakeholder Update - November 2, 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

1. Reduce the burden of addiction crises that are threatening American families

• Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s continued efforts to address growing epidemic of youth e-cigarette use, including potential new therapies to support cessation Over the past several months, we’ve continued to voice our concerns about the growing epidemic of youth e-cigarette use. Our public statements have expectedly prompted responses from industry and public health stakeholders on ways they and the FDA can further address these concerning trends. Read full statement posted on November 2, 2018
• Statement from FDA Commissioner Scott Gottlieb, M.D., on meetings with industry related to the agency’s ongoing policy commitment to firmly address rising epidemic rates in youth e-cigarette use Last month, Dr. Gottlieb, issued a call to action – to the FDA and to the e-cigarette industry – to stem the alarming increase in youth use of e-cigarettes. For the FDA, that has included an escalating series of steps that utilize the full range of our regulatory authorities, including increased enforcement of age- and identification-verification requirements, as well as re-examining aspects of our comprehensive plan on tobacco and nicotine regulation in order to strengthen our Youth Tobacco Prevention Plan. Read full statement posted on October 31, 2018

2. Leverage innovation and competition to improve health care, broaden access, and advance public health goals

• The Medical Device Ecosystem and Cybersecurity — Building Capabilities and Advancing Contributions by: Suzanne B. Schwartz, M.D., M.B.A,Associate Director for Science and Strategic Partnerships, at the Center for Devices and Radiological Health Ensuring medical devices are safeguarded from cyber intrusions is a shared responsibility across the medical device ecosystem. At the FDA, we deal with cybersecurity in the context of the total product lifecycle of a device. But we also tackle the issue as it evolves in the cyber ecosystem, where devices are part of an interconnected cyber — physical infrastructure among people. Read full FDA Voice posted on November 2, 2018
• FDA authorizes first direct-to-consumer test for detecting genetic variants that may be associated with medication metabolism FDA permitted marketing, with special controls, of the 23andMe Personal Genome Service Pharmacogenetic Reports test as a direct-to-consumer test for providing information about genetic variants that may be associated with a patient’s ability to metabolize some medications to help inform discussions with a health care provider. The FDA is authorizing the test to detect 33 variants for multiple genes. Read full news released on October 31, 2018

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 Jeffrey Shuren, M.D., J.D., Director of the FDA’s Center for Devices and Radiological Health on the National Toxicology Program’s report on radiofrequency energy exposure FDA is charged with ensuring cell phones— and any radiation-emitting electronic product—are safe for the public to use. Our scientific expertise and input, along with other health agencies, are used by the Federal Communications Commission (FCC) to set the standards for exposure limits of radiation from cell phones, called radiofrequency energy. Read full statement posted on November 1, 2018
• FDA Statement from Jeffrey Shuren, M.D., J.D., Director, Center for Devices and Radiological Health and Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research on agency’s warning to consumers about genetic tests that claim to predict patients’ responses to specific medications As a public health agency, one of our key roles is to promote and advance safe and effective medical product innovations. One rapidly advancing, and very promising, area of science and medicine is the field of genetic tests. Read full statement posted on November 1, 2018
• FDA to Hold Four Public Meetings to Discuss Draft Produce Safety Rule Guidance The public meetings will be held in different regions of the country to provide information and facilitate comment so that stakeholders can better evaluate and provide input on the draft Produce Safety Rule guidance. The information presented will focus on the various chapters of the draft guidance: general provisions; personnel qualifications and training; health and hygiene; biological soil amendments of animal origin; domesticated and wild animals; growing, harvesting, packing and holding activities on a farm; equipment, tools, buildings, and sanitation; records; and variances. Stakeholder panels will discuss various issues. There will be opportunities for questions and open public comment. Read full update posted on October 31, 2018
• Statement from FDA Commissioner Scott Gottlieb, M.D., and Deputy Commissioner Anna Abram on the FDA’s new plan to advance plant, animal biotechnology innovation Innovations in plant and animal biotechnology offer tremendous opportunities for advancing public health. Promising new technologies that can edit animal and plant genomes have the potential to improve human and animal health, animal well-being, food productivity and food security. Read full statement posted on October 30, 2018
• October 29, 2018 - Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA’s new consideration of labeling for sesame allergies Food allergies have touched the lives of most of us. Thousands of Americans experience life-threatening, food-related reactions each year, and an estimated 20 people die from them annually. In some cases, such reactions occur despite a careful reading of packaged food labels by conscientious consumers. Read full statement posted on October 29, 2018

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