Stakeholder Engagement Update - April 26, 2019

FDA's Stakeholder Engagement Staff works to provide you with up-to-date information that helps to further our commitment in advancing public health and well-being. A few notable items were issued this week, including:

FDA Press Releases FDA launches public education campaign to encourage safe removal of unused opioid pain medicines from homes FDA announced the launch of a new education campaign to help Americans understand the important role they play in removing and properly disposing of unused prescription opioids from their homes.

Statement from Jeffrey Shuren, M.D., J.D., Director of the FDA’s Center for Devices and Radiological Health, on new steps to help reduce risks associated with surgical staplers for internal use and implantable staples As part of the FDA's mission to protect the public health, outlined in our Medical Device Safety Action Plan, we are committed to continuing to strengthen and modernize how we take action to address device safety issues that emerge in the post-market in a more timely and effective way. Also as part of our public health mission, it is important that we communicate with the public when we become aware of issues stemming from the use, or misuse, of medical devices. Statement from Peter Marks, M.D., Ph.D., director of FDA’s Center for Biologics Evaluation and Research, on FDA’s continued confidence in the safety and effectiveness of the measles, mumps, and rubella (MMR) vaccine The FDA is a public health agency that always strives to use the best available scientific evidence to promote and protect the well being of individuals. It deeply concerns us when we see preventable diseases such as measles or mumps reemerging in the United States and threatening our communities. Consumer Update

Be Aware of Potentially Dangerous Products That Claim to Treat Autism Products or treatments claiming to cure autism are deceptive and misleading, because there is no cure for autism. The same is true of many products claiming to “treat” autism or autism-related symptoms. Some may carry significant health risks. FDA plays an important role in warning companies against making improper claims about their products’ intended use as a treatment or cure for autism or autism-related symptoms

FDA Voice Rapid Response Teams Mark 10 Years of Collaboration on Public Health Emergencies By: Barbara Cassens, Director, Office of Partnerships, Office of Regulatory Affairs Responding to health emergencies, such as the current multi-state outbreak of Salmonella Carrau linked to pre-cut melons, has long been a top priority at the FDA. The agency is working with the Centers for Disease Control and Prevention and our state partners to trace the specific source of these melons and collect samples for laboratory analysis. The outbreak required multiple agencies to work together to inspect and investigate. Such an effort was also required to trace the 2018 E. coli outbreak linked to romaine lettuce from California.

Upcoming FDA Meetings, Conferences and Workshops 5/13/2019; 9:00 AM - 5:00 PM EDT : The Future of Insulin Biosimilars: Increasing Access and Facilitating the Efficient Development of Biosimilar and Interchangeable Insulin Products FDA public hearing to receive input as the Agency prepares for the submission and review of applications for biosimilar and interchangeable insulin products. 05/16/2019; 1:00 PM - 3:00 PM EDT : Project Facilitate: Enhancing the Single Patient IND Process for Oncology Health Care Providers  A public workshop to discuss Project Facilitate, a call center to facilitate the Single Patient IND request process for oncologists treating cancer patients. 5/31/2019; 8:00 AM - 6:00 PM EDT : Scientific Data and Information about Products Containing Cannabis or Cannabis-Derived Compounds; Public Hearing.

The FDA Stakeholder Engagement Staff reside within the Office of the Commissioner and support the FDA mission by engaging with Patient and Health Professional Organizations, Consumer Groups, Trade Associations, Think Tanks and other external stakeholders.  We encourage and support active engagement from external stakeholders related to policy that impacts medical products, tobacco, food safety and nutrition that promote health and healthy living.