FDA Stakeholder Update - January 23, 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 expands youth e-cigarette prevention campaign to include stories from teenagers addicted to nicotine

“The troubling epidemic of youth vaping threatens to erase years of progress in combatting tobacco use among youth. We are working tirelessly to tackle this concerning trend, including through our recently released compliance policy focusing on, among other priorities, unauthorized flavored cartridge-based e-cigarettes most popular with youth. We also know it is imperative to continue to educate our nation’s youth about the dangers of these products, so they can make the smart, well-informed choice to not use these products. “The new videos that launch this week as part of our youth e-cigarette prevention campaign feature real stories from teens who have become addicted to e-cigarettes. These powerful narratives from youth show their peers the disastrous impact of e-cigarette addiction, like the teens who developed severe anxiety and depression after using e-cigarettes or the high school athlete who could no longer compete."  The quote is attributed to FDA Commissioner Stephen M. Hahn, M.D. [01/21/2020]

FDA announces results from sunscreen absorption study

“Given the recognized public health benefits of sunscreen use, the FDA urges Americans to use sunscreens in conjunction with other sun protective measures (such as protective clothing). To support sunscreen safety, the FDA tested whether various sunscreen ingredients can be absorbed through the skin into the body.” “Results from our study show there is evidence that some sunscreen active ingredients may be absorbed. However, the fact that an ingredient is absorbed through the skin and into the body does not mean that the ingredient is unsafe, nor does the FDA seeking further information indicate such. Rather, this finding calls for further industry testing to determine the safety and effect of systemic exposure of sunscreen ingredients, especially with chronic use.”  The quote is attributed to Janet Woodcock, M.D., Director of the FDA’s Center for Drug Evaluation and Research. [01/21/2020]

Request for Comment

Submission of Plans for Cigarette Packages and Cigarette Advertisements - By January 29, 2020 This guidance, when finalized, would assist those required to submit cigarette plans for cigarette packages and cigarette advertisements by providing recommendations related to those submissions, including information on what should be in a cigarette plan, who should submit a cigarette plan, and when to submit a cigarette plan. Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act - By February 21, 2020 This guidance describes recommended procedures to obtain an additional National Drug Code (NDC) for an FDA-approved prescription drug that is imported into the United States in compliance with section 801 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 106 U.S.C. 381). This guidance specifically addresses the importation of FDA-approved drugs that were also authorized for sale in a foreign country in which the drugs were originally intended to be marketed (hereinafter “multi-market approved product” or “MMA product)." Pediatric Study Plans for Oncology Drugs: Transitional Information Until Full Implementation of FDARA Section 504 Questions and Answers - By March 16, 2020 The purpose of this guidance is to provide information to sponsors regarding the submission of an initial pediatric study plan (iPSP), as required by section 505B(e) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), for oncology drugs only.

FDA Voices

FDA Harnesses Technology and Collaboration to Support Rare Disease Product Development Announcing an Orphan Drug Technology Modernization effort and the 2020 FDA Rare Disease Day meeting

By: Amy Abernethy, M.D., Ph.D., Principal Deputy Commissioner and Acting Chief Information Officer and Janet Maynard, M.D., M.H.S., Director, Office of Orphan Products Development

Patients and their families are the focus of our work at the FDA. We ensure that treatments for diseases are safe and effective. Patients and their families are experts in their diseases and help inform many aspects of medical product development. This is especially notable in rare diseases, where product development can be challenging given the small number of patients affected with a given disease and the potential for limited understanding of the pathophysiology of some rare diseases. [1/17/2020]

Shedding More Light on Sunscreen Absorption

By: Theresa M. Michele, M.D., Director, Office of Nonprescription Drugs, Office of New Drugs, Center for Drug Evaluation and Research, and David Strauss, M.D., Ph.D., Director, Division of Applied Regulatory Science, Office of Translational Sciences, Center for Drug Evaluation and Research Even on cold, cloudy winter days, sunscreen safety remains a top priority at the FDA, as well it should since sunscreens are recommended for year-round use. The FDA’s newly-published research in the Journal of the American Medical Association (JAMA) External Link Disclaimer provides much-needed additional information about the absorption of the active ingredients in sunscreens into the body’s bloodstream after they are applied to the skin. [01/21/2020]

Public Meetings and Workshops Understanding How the Public Perceives and Values Pharmaceutical Quality MEETING INFORMATION: This meeting will provide an opportunity to explore and better understand how stakeholders perceive and value the quality of pharmaceutical products. Key FDA leadership and staff will provide comments on the Agency’s current thinking and there will be opportunities for attendees to ask questions and engage with panelists. DATE: February 3, 2020 TIME: 9:30 AM - 11:30 AM ET  LOCATION: National Press Club - 529 14th St NW, Washington, DC 20045 REGISTER: In person attendance is limited, please register at your earliest convenience. Testing Methods for Asbestos in Talc and Cosmetic Products Containing Talc MEETING INFORMATION: The purpose of the meeting is to discuss and obtain scientific data and information on topics related to testing methodologies, terminology, and criteria that can be applied to characterize and measure asbestos and other potentially harmful elongate mineral particles (EMPs) that may be present as contaminants in talc and consumer products, including cosmetics, containing talc as an ingredient. DATE: February 4, 2020 TIME: 8:30 AM - 5:00 PM ET  LOCATION: FDA White Oak Campus - 10903 New Hampshire Avenue, Bldg. 31, (The Great Room) Silver Spring, MD, 20993

Recall and Safety Information

Surgical Gowns and Packs by Cardinal Health: Potential Quality Issues Affecting Some of its Level 3 Surgical Gowns and Accompanying PreSource Procedural Packs

The medical device manufacturer Cardinal Health alerted its customers to potential quality issues affecting some of its Level 3 surgical gowns and accompanying PreSource procedural packs. FDA also understands this issue may already be impacting patient care at health care facilities, such as the cancellation of non-elective surgeries. There are very real consequences that medical device supply chain disruptions can have on patients, and FDA is committed to taking what steps we can to mitigate any adverse patient impact. [01/16/2020]