FDA Stakeholder Update - July 25, 2019

Dear Colleague, 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.

FDA Announcements

Federal Register Notice: Comment Request; Report on the State of Counterfeit and Pirated Goods Trafficking and Recommendations The Department of Commerce opened a public docket to collect comments from across all federal agencies.  FDA urges industry, stakeholders and consumers to submit comments to the docket on counterfeit products within FDA’s purview. Publish Date: 07/10/2019; Comment Period End Date:  5:00 P.M. ET, 7/29/2019 FDA takes action to protect patients from risk of certain textured breast implants; requests Allergan voluntarily recall certain breast implants and tissue expanders from market The FDA took significant action to protect women from breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) by requesting that Allergan, the manufacturer of a specific type of textured implant, recall specific models of its textured breast implants from the U.S. market due to the risk of BIA-ALCL. Following the agency’s request, Allergan has notified the FDA that it is moving forward with a worldwide recall of their BIOCELL textured breast implant products, including: Natrelle Saline-Filled breast implants, Natrelle Silicone-Filled breast implants, Natrelle Inspira Silicone-Filled breast implants, and Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled breast implants. [July 24, 2019]

FDA launches its first youth e-cigarette prevention TV ads, plans new educational resources as agency approaches one-year anniversary of public education campaign. The FDA announced the launch of its first e-cigarette prevention TV ads educating kids about the dangers of e-cigarette use. The FDA also plans to provide new posters for high schools and educational materials for middle schools across the U.S. as part of “The Real Cost” Youth E-Cigarette Prevention Campaign. As the campaign’s one-year anniversary approaches, the new TV ads and school resources are designed to continue to engage youth with important public health messages about the risks of e-cigarette use. [July 22, 2019]

FDA Meetings & Workshops Workshop: FDA Public Meeting - Endpoints for Drug Development in Heart Failure Date: July 26, 2019 Time: 09:00 AM EDT – 04:00 PM EDT Description: The purpose of this public meeting is to bring the stakeholder community together to discuss clinical endpoints for trials in heart failure that could be used to support FDA approval of drugs. The workshop will focus on endpoints related to symptoms and physical function. In addition, there will be discussion of the need to assess mortality effects of drugs under development for heart failure. Registration: Eventbrite 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 human and animal medical products, cosmetics, tobacco, nutrition and food safety that promote health and healthy living.