FDA Stakeholder Update - August 8, 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 Announcement

FDA notifies four companies to remove 44 flavored e-liquid and hookah tobacco products from the market for not having required marketing authorization Today, the FDA issued warning letters notifying four companies that 44 flavored e-liquid and hookah tobacco products do not have the required marketing authorization, and thus cannot be legally sold in the United States. These new actions are part of the FDA’s ongoing, aggressive effort to investigate and take action against illegally marketed tobacco products amid the epidemic of youth e-cigarette use in America. “Today’s actions make clear that we will continue to keep a close watch on whether companies are breaking the law and will take swift steps when violations are found. Our work in this area has already resulted in a number of companies removing products from the market,” said Acting FDA Commissioner Ned Sharpless, M.D. “The marketing of illegal tobacco products is particularly concerning given the epidemic of youth vaping that we’re facing, which we know has resulted in part from irresponsible practices of manufacturers, importers and retailers who have targeted kids in their marketing of these products. We are committed to tackling the troubling trend of youth e-cigarette use by continuing to use all available regulatory tools to ensure these products aren’t being marketed to, sold to, or used by kids. It is critical that we remain vigilant in our efforts to stem the increase in use and nicotine addiction in children driven by e-cigarettes, which threatens to erase the years of progress we’ve made combating tobacco use among kids.” [8/08/2019] FDA In Brief

FDA encourages continued submission of reports related to seizures following e-cigarette use as part of agency’s ongoing scientific investigation of potential safety issue The FDA provided an update on its ongoing scientific investigation of a potential safety issue related to seizures reported following e-cigarette use and is continuing to encourage the public to submit new or follow-up reports on this topic as requested in the agency’s announcement in April. [8/07/2019] FDA issues annual report on efforts to hold industry accountable for fulfilling critical post-marketing studies of the benefits, safety of new drugs The FDA released the Report on the Performance of Drugs and Biologics Firm in Conducting Postmarketing Requirements (PMRs) and Postmarketing Commitments (PMCs) Fiscal Year 2018 detailing the progress made by industry in fulfilling certain postmarketing studies. Once the need for a PMR or PMC is established, the company must report on the progress within 60 days of the anniversary date of the drug product’s approval until the FDA determines that the PMR or PMC has been fulfilled, is no longer feasible or would no longer provide useful information. All PMRs and certain PMCs are required to have a timetable for completion. [8/06/2019] FDA Statement Data accuracy issues with recently approved gene therapy Statement from Dr. Peter Marks M.D. PhD., Director - Center for Biologics Evaluation and Research (CBER) As a public health agency, we believe that it is critical to facilitate the development of innovative safe and effective medical products, like the cellular and gene therapy products that have shown enormous potential to treat previously untreatable diseases. As part of the approval process for biological products, the agency reviews extensive information submitted by manufacturers, including details of how the product is made in a reproducible manner, how it has been tested in animals, and how it has been investigated in human clinical trials to demonstrate its safety and efficacy.  It is the manufacturer’s responsibility to submit complete and accurate information in marketing applications for evaluation by the FDA. If we become aware of a concern with data submitted to the agency as part of our review of a product application, it is in the best interest of patients, their caregivers, and the public that we disclose such information, to the extent permitted by law. [8/06/2019]

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.