FDA Stakeholder Update - February 20, 2020

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 Announcement FDA Works to Ensure Smooth Regulatory Transition of Insulin and Other Biological Products Today, the FDA took additional steps to ensure a smooth regulatory transition aimed at increasing patient access to insulin products used daily by millions of Americans to maintain stable blood glucose levels, as well as certain other biological products set to transition regulatory pathways in March. Today’s actions include publishing a final rule and additional resources to provide useful information to stakeholders, including industry, patients and health care providers. On March 23, 2020, an application for a biological product approved under the Federal Food, Drug, and Cosmetic Act (FD&C Act), including applications for insulins and other biological products, will be deemed to be a license for the product under the Public Health Service (PHS) Act. This will, for the first time, enable submission of applications for products that are proposed as biosimilar to, or interchangeable with, the transitioned products. [02/20/2020] FDA Announces Collaborative Review of Scientific Evidence to Support Associations Between Genetic Information and Specific Medications Pharmacogenetic testing is a type of genetic test that in some instances can predict how a person will respond to specific medications. Thus, this type of testing offers promise for informing the selection or dosing of some medications for certain individuals. When there is sufficient scientific evidence demonstrating a relationship between how a person’s genes may impact their metabolism of a drug or how they may respond to the drug, this information can be useful for health care providers. However, for many medications, there is not sufficient scientific evidence to support using pharmacogenetic test results to inform prescribing decisions. These statements are from CDRH's Director, Jeffrey E. Shuren M.D., JD and CDER's Director, Janet Woodcock M.D.  FDA Takes Action with Indian Government to Protect Consumers From Illicit Medical Products  The FDA announced that its first bilateral enforcement operation with the Government of India, stopped approximately 500 shipments of illicit, and potentially dangerous, unapproved prescription drugs and combination medical devices from reaching American consumers over the course of an operation that took place in January. [02/18/2020] FDA’s Actions in Response to 2019 Novel Coronavirus at Home and Abroad - Statement from FDA's Commissioner Stephen M. Hahn, M.D.

The FDA plays an essential role in overseeing our Nation’s medical products as part of our vital mission to protect and promote public health, including during public health emergencies. The FDA is an active partner in the Novel Coronavirus (COVID-19) response, working closely with our government and public health partners across the U.S. Department of Health and Human Services, as well as with our international counterparts. [02/14/2020]

FDA In Brief FDA Reopens Comment Period Related to General Principles for Food Standards of Identity Modernization The FDA is reopening the comment period on a 2005 proposed rule to establish a set of general principles to use when considering whether to establish, revise or eliminate a food standard of identity. While the original proposed rule was jointly published with the U.S. Department of Agriculture (USDA), the FDA is only seeking comments on the agency’s specific aspects of the proposed rule, including 13 general principles for food standards modernization. The FDA and USDA will continue to engage on standard of identity modernization. [02/20/2020] FDA Seeks Input from the Public to Help Prevent Future Lung Injuries Associated with Vaping The FDA opened a docket to obtain data and information related to the use of vaping products that are associated with e-cigarette, or vaping, product use-associated lung injury (EVALI). This request for information responds to direction from Congress to gather information from the public that could help identify and evaluate additional steps the FDA could take to address the recent lung injuries associated with the use of vaping products and to help prevent similar occurrences in the future. [02/14/2020]

Public Meetings and Workshops FDA Rare Disease Day 2020: Supporting the Future of Rare Disease Product Development Date: February 24, 2020 Time: 9:00 AM - 5:00 PM ET Location: FDA White Oak Campus: The Great Room Conference Center, 10903 New Hampshire Ave, Building 31 - Room 1503, Silver Spring, MD 20993 Agenda: This meeting will include perspectives from various stakeholders in rare disease product development. The specific goal of this meeting is to identify challenges and solutions in rare disease product development to optimize rare disease medical product development.  Register: If you wish to attend in-person or via webcast, please register at Eventbrite. Patient-Focused Drug Development (PFDD) for Stimulant Use Disorder Date: March 10, 2020 Time: 12:30 PM - 5:00 PM ET Location: Silver Spring Civic Building, 1 Veterans Plaza, Silver Spring, MD 20910 Agenda: This meeting will provide FDA the opportunity to obtain input from individuals who are struggling or have struggled with the use of cocaine, methamphetamine, crystal meth, or misuse of prescription stimulants such as Adderall or Ritalin. Family members, advocates, caregivers and other stakeholders are encouraged to participate and share their views on the condition. Register: If you wish to attend in-person or via webcast, please register at Eventbrite. Patient-Focused Drug Development (PFDD) for Vitiligo Date: March 30, 2020 Time: 1:00 PM - 5:00 PM ET Location: FDA White Oak Campus: The Great Room Conference Center, 10903 New Hampshire Ave, Building 31, Room 1503, Silver Spring, MD 20993 Agenda: The FDA is interested in hearing patients’ perspectives on the impact of vitiligo on daily life and patient views on treatment approaches. Register: If you wish to attend in-person or via webcast, please register at Eventbrite. For a more comprehensive list of public meetings involving the FDA, please visit here.