FDA Stakeholder Update - October 3, 2019

Dear Colleague, FDA's Stakeholder Engagement Staff works to provide you with up-to-date information to further our commitment to advance public health and well-being.

FDA Announcements FDA and DEA warn website operators illegally selling opioids  The FDA and the U.S. Drug Enforcement Administration have issued joint warning letters to four online networks, operating a total of 10 websites, illegally marketing unapproved and misbranded versions of opioid medicines, including tramadol, that are potentially dangerous. The warning letters issued to each of the networks state that they must immediately stop illegally selling these opioids to American consumers. This joint action demonstrates the federal government’s commitment to enhance interagency coordination to respond to the opioid crisis. [9/30/2019] FDA issues draft guidance on Patient-Focused Drug Development: Methods to Identify What Is Important to Patients; Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders This guidance (Guidance 2) is the second in a series of guidance documents that FDA is developing to describe, in a stepwise manner, how stakeholders (patients, researchers, medical product developers and others) can collect and submit patient experience data and other relevant information from patients and caregivers to be used for medical product development and regulatory decision-making. Guidance 2 describes methods to identify what matters most to patients regarding burden of disease and burden of treatment to guide medical product development, including endpoint development.  [9/30/2019]

FDA In Brief FDA awards grant to the National Association of Boards of Pharmacy (NABP) to establish an information-sharing system and research interstate distribution of compounded drugs The FDA is announcing that it has awarded a cooperative agreement grant to the National Association of Boards of Pharmacy (NABP) to establish an information-sharing system for drug compounding activities that are primarily overseen by states. The roughly three-year pilot project undertaken through this grant will work to improve the information available to state regulators and the FDA about state-licensed entities, primarily pharmacies, that engage in drug compounding and distribute compounded drugs interstate. The overall goal is to help provide more targeted regulation and oversight of compounded drugs, while ultimately reducing risk to patients. [10/02/2019]

FDA Voices The FDA’s Critical Focus on Women’s Health The FDA takes very seriously its long-standing commitment and approach to women’s health. By: Amy Abernethy, M.D., Principal Deputy Commissioner, Kaveeta Vasisht, M.D., Pharm.D., Acting Associate Commissioner for Women’s Health, Office of Women’s Health, and, CAPT Terri L. Cornelison, M.D., Ph.D., Chief Medical Officer and Director, Health of Women Program, Center for Devices and Radiological Health For the past 25 years, the U.S. Food and Drug Administration's Office of Women’s Health has forged a pathway fostering and supporting advancements in the health of women through its work across the agency and with stakeholders. Developments in science have advanced our understanding of the unique role that sex and gender play in health and disease. Sex refers to an individual’s biological characteristics, stemming from chromosomal complement. Alternatively, gender refers to the social construct by which we define ourselves as woman, man or other. [10/03/2019]

Public Meetings and Workshops Science Board to the FDA Meeting Announcement- AdCom Agenda: The Science Board will hear a response from the Center for Biologics Evaluation and Research to the recommendations made by the Science Board’s review of CBER’s research program.  Date: Mon., October 7, 2019: Time: 08:30 AM - 01:30 PM EDT Location: White Oak Campus - The Great Room, Conference Center Vaccines and Related Biological Products AdCom Agenda: The Center for Biologics Evaluation and Research's (CBER) Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet in open session to hear an overview of the research programs in the Laboratory of Hepatitis Viruses (LIR) and the Laboratory of Vector-Borne Viral Diseases (LVVD), Division of Viral Products, Office of Vaccines Research and Review, CBER, FDA.  Date: Wed., October 9, 2019: Time: 08:30 AM - 03:30 PM EDT Location: White Oak Campus - The Great Room, Conference Center