FDA Stakeholder Update - October 17, 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 Statement on continued progress enhancing patient access to high-quality, low-cost generic drugs From Norman E. "Ned" Sharpless MD, FDA Acting Commissioner  Affordable access to medicines is a public health concern and more generic drug competition can help reduce prices, improve access and benefit the public health. Safe, effective and high-quality generic drugs play a vital role in our health care system. Generic drugs account for about 90% of all prescription drug purchases in the U.S. In 2018, competition from generic drugs saved the health care system about $293 billion. Thanks to the FDA’s ongoing efforts under the Drug Competition Action Plan and the Generic Drug User Fee Amendments, the FDA has built a thriving generic drug program that continues to impress me. I am pleased to report that our generic drug program is having another strong year.

Updates Related to Vaping Products FDA’s Forensic Chemistry Center Playing Critical Role in Vaping Illness Investigation FDA’s Forensic Chemistry Center serves as the agency’s premier national forensic laboratory for research and analyses related to criminal and regulatory investigations involving FDA-regulated products. Based in Cincinnati, Ohio, the Forensic Chemistry Center is one of thirteen laboratories in FDA’s Office of Regulatory Affairs and is leading FDA’s efforts in the investigation of nationwide vaping illnesses, working closely with the U.S. Centers for Disease Control and Prevention (CDC) and federal and state partners to try to identify the products or substances that may be causing the illnesses and deaths associated with the use of vaping products. [10/11/2019]

Consumer Update What You Should Know About Using Cannabis, Including CBD, When Pregnant or Breastfeeding Cannabis and Cannabis-derived products have become increasingly available in recent years, with new and different types of products appearing all the time. These products raise questions and concerns for many consumers. And if you are pregnant or breastfeeding, you might have even more questions about whether these products are safe for you.

FDA strongly advises against the use of cannabidiol (CBD), tetrahydrocannabinol (THC), and marijuana in any form during pregnancy or while breastfeeding. [10/16/2019]

Public Meetings Public Hearing: Use of Fecal Microbiota for Transplantation (FMT) to Treat Clostridium difficile Infection Not Responsive to Standard Therapies The purpose of the public hearing is to obtain public input on the state of the science regarding FMT to treat C. difficile infection not responsive to standard therapies, including the available clinical evidence for safety and effectiveness of FMT for this use and to better understand the impact of FDA’s enforcement policy on product development.  Date: November 04, 2019 Time: 09:00 AM - 04:00 PM EST Location: White Oak Campus - The Great Room, Conference Center Registration: Early registration is recommended because seating is limited. Please register here.