FDA Stakeholder Update - January 16, 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 Statement on quality issues with certain Cardinal Health surgical gowns and packs Statement from Jeffrey Shuren, M.D., J.D., Director of the FDA’s Center for Devices and Radiological Health On Jan. 11 and again on Jan. 15, 2020, medical device manufacturer Cardinal Health alerted its customers to potential quality issues affecting some of its Level 3 surgical gowns and PreSource procedural packs that contain these gowns. Cardinal Health recommends, and the FDA agrees, that customers should immediately discontinue use of all affected surgical gowns and PreSource procedural packs that include these surgical gowns because the manufacturer cannot provide assurance the products are sterile. The FDA is working to assess the cause and full impact of these concerns. [01/16/2020] Statement on the Salinas-linked romaine lettuce E. coli O157:H7 outbreak and status update on investigation The FDA, along with the U.S. Centers for Disease Control and Prevention and state and local partners, previously reported on Dec. 12 that public health experts were tracking three separate outbreaks linked to romaine lettuce caused by three different strains of E. coli O157:H7. We also reported that, through the FDA’s traceback investigation, we were able to identify a common grower between each of these outbreaks in Salinas, California based on available supply chain information. [01/15/2020] FDA Fact Sheet on Right to Try The Right to Try Act, or the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act, was signed into law May 30, 2018. This law is another way for patients who have been diagnosed with life-threatening diseases or conditions who have tried all approved treatment options and who are unable to participate in a clinical trial to access certain unapproved treatments. Clinical trials provide information about whether a product is safe to use and can effectively treat or prevent a disease. People may have many reasons for participating in clinical trials. In addition to contributing to medical knowledge, some people participate in clinical trials because there is no treatment for their disease, treatments they tried have not worked, or they are not able to tolerate the current treatments. [01/14/2020] Michigan-based food manufacturer agrees to stop production after repeated food safety violations U.S. District Judge Sean F. Cox entered a consent decree of permanent injunction between the U.S. and Home Style Foods, Inc., and the company’s owner, Michael J. Kowalski, and quality manager, Juan Valesquez. Home Style Foods, Inc., a Michigan-based food manufacturer, has agreed to discontinue selling food products until the company complies with federal regulations and other requirements. This action follows several inspections conducted by the FDA, which found Listeria monocytogenes (L. mono) in the company’s food preparation area and violations of seafood safety regulations associated with the processing of fish and fishery products. [01/13/2020] FDA, USDA and EPA announce joint platform to streamline information about agricultural biotechnology products In recognition of January 2020 as National Biotechnology Month, the FDA, the Department of Agriculture and the Environmental Protection Agency launched a Unified Website for Biotechnology Regulation. The website streamlines information about the three regulatory agencies charged with overseeing agriculture biotechnology products and is part of President Donald J. Trump’s Executive Order on Modernizing the Regulatory Framework for Agricultural Biotechnology Products. [01/09/2020]

FDA in Brief FDA provides updates on discontinuation of Essure and ongoing postmarket activities “While Essure devices have not been sold in the U.S. for more than a year, the FDA engaged directly with Bayer to help to ensure that previously sold but unused devices were returned to the company by the close of 2019. Efforts included Bayer proactively reaching out to health care professionals and facilities to return unused Essure devices so that they would no longer be available for implantation. “Bayer’s efforts to reach customers went through the end of 2019 and have been largely successful in retrieving the vast majority of unused Essure devices such that they are no longer available for implantation in the U.S. As of today, Bayer has reported to the agency that over 99% of unused devices have been returned. Bayer is aware of 10 unused devices that they are actively seeking to retrieve. They continue to process the returns and update the FDA on their efforts to obtain the remaining unused Essure devices." The quote is attributed to Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health [01/10/2020]

Public Meetings and Workshops PUBLIC MEETING - Testing Methods for Asbestos in Talc and Cosmetic Products Containing Talc 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 PUBLIC WORKSHOP- Facilitating End-to-End Development of Individualized Therapeutics DATE: March 3, 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 PUBLIC WORKSHOP- Medical Extended Reality: Toward Best Evaluation Practices for Virtual and Augmented Reality in Medicine. DATE: March 5, 2020 TIME: 8:30 AM - 5:00 PM ET LOCATION: FDA White Oak Campus - 10903 New Hampshire Avenue, Bldg. 31, Room 1503 (the Great Room) Silver Spring, MD, 20993

Request for Comment Submission of Plans for Cigarette Packages and Cigarette Advertisements - SUBMIT BY JANUARY 29, 2020 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 - SUBMIT BY FEBRUARY 21, 2020 Pediatric Study Plans for Oncology Drugs: Transitional Information Until Full Implementation of FDARA Section 504 Questions and Answers - SUBMIT BY MARCH 16, 2020