FDA Stakeholder Update - August 2, 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

HHS Announces New Action Plan to Lay Foundation for Safe Importation of Certain Prescription Drugs The U.S. Department of Health and Human Services (HHS) announced that HHS and the U.FDA are publishing a Safe Importation Action Plan - PDF* that outlines two potential pathways that would lay the foundation for the safe importation of certain drugs originally intended for foreign markets. “President Trump has been clear: for too long American patients have been paying exorbitantly high prices for prescription drugs that are made available to other countries at lower prices. When we released the President’s drug pricing blueprint - PDF for putting American patients first, we said we are open to all potential solutions to combat high drug prices that protect patient safety, are effective at delivering lower prices, and respect choice, innovation and access,” said Health and Human Services Secretary Alex Azar. [7/31/2019] FDA clears new indications for existing Lyme disease tests that may help streamline diagnoses The FDA cleared for marketing four previously cleared tests with new indications to aid in the diagnosis of Lyme disease. The tests cleared today are the first time that a test has been indicated to follow a new testing paradigm in which two tests called enzyme immunoassays (EIA) are run concurrently or sequentially, rather than the current two-step process in which a separate protein test called a Western Blot must be run after the initial EIA test. [7/29/2019] Recall and Safety Informtion

FDA Investigates Contaminated Pig Ear Pet Treats Connected to Human Salmonella Infections FDA and CDC are advising that consumers avoid all pig ear pet treats and retailers stop selling all pig ear treats at this time. Lennox Intl Inc., a distributor of pig ear pet treats, has initiated a recall for some of the treats involved in this outbreak. CDC announced that there are now a total of 127 people infected with the outbreak strain of Salmonella, reported from 33 states. Twenty-six ill people have been hospitalized. No deaths have been reported.. [07/31/2019]

FDA In Brief FDA seeks comment on proposed additions to list of harmful and potentially harmful constituents found in tobacco products, including electronic nicotine delivery systems such as e-cigarettes and e-liquids “As our oversight and scientific knowledge of tobacco products has evolved, so too should our requirements for manufacturers and importers to provide information about the chemicals or chemical compounds in their products that cause or could cause harm to users and nonusers. We welcome comment on the proposed additions to the list of harmful and potentially harmful constituents of 19 toxicants that may be found in tobacco products, including electronic nicotine delivery systems such as e-liquids and e-cigarette aerosol,” said Acting FDA Commissioner Ned Sharpless, M.D. “We remain committed to meeting the important goal of ensuring the public can clearly understand the real and potential risks of tobacco product use as we work to protect kids and significantly reduce tobacco-related disease and death.”[08/02/2019] FDA issues a revised Draft Guidance for Industry on Rare Pediatric Disease Priority Review Vouchers The FDA issued a revised draft guidance, Rare Pediatric Disease Priority Review Vouchers – Guidance for Industry. The revised draft guidance incorporates public comments received on the initial draft and provides FDA’s thinking regarding the provisions of the Advancing Hope Act of 2016, which updated the definition of a rare pediatrics disease as one that is a rare disease and one where the disease is serious or life-threatening with the serious or life-threatening manifestations primarily affecting individuals from age zero to 18. Among the key changes from the initial draft are an explanation of the rare pediatric disease priority review voucher eligibility requirements, the rare pediatric disease designation process and examples to illustrate the agency’s current thinking on these review determinations. The agency is accepting public comment on the revised draft guidance. [7/29/2019] Request for Comment

Request for Comment by 10/01/2019 - Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment: FDA developed this draft guidance to provide FDA's recommendations on the testing needed for assessing the safety and compatibility of medical devices in the Magnetic Resonance (MR) Environment and the recommended format for Magnetic Resonance Imaging (MRI) Safety Information in medical device labeling. This draft guidance document is anticipated to aid in consistency of reviews, testing, and MRI safety labeling across a variety of medical devices. This draft guidance is not final nor is it in effect at this time. Request for Comment by 09/30/2019 - Rare Pediatric Disease Pediatric Priority Review Vouchers; Draft Guidance for Industry: This draft guidance provides information on the rare pediatric disease priority review voucher program under the Federal Food, Drug, and Cosmetic Act (FD&C Act), under which FDA will award priority review vouchers to sponsors of certain rare pediatric disease product applications that meet the relevant statutory criteria. These priority review vouchers can be used when submitting future human drug marketing applications that would not otherwise qualify for priority review. Because there exists a need for products for rare pediatric diseases, this program is intended to encourage development of new drug and biological products for prevention and treatment of certain rare pediatric diseases.

About Us 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.