FDA Stakeholder Update - December 12, 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 Announcement Statement from Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research, on impurities found in diabetes drugs outside the U.S. FDA has been investigating the presence of genotoxic impurities, called nitrosamines, in some types of drugs. Over the past year and a half, several drug products including angiotensin II receptor blockers (ARBs) and ranitidine, commonly known as Zantac, have been found to contain small amounts of nitrosamines such as N-Nitrosodimethylamine (NDMA). During this time, there has been an ongoing investigation into the presence of nitrosamines in other drug products. This effort is focused on ensuring the drugs used by Americans continue to meet strict quality standards. The FDA is aware that some metformin diabetes medicines in other countries were reported to have low levels of NDMA. Based on the information we have available, the levels of NDMA seen outside the U.S. are within the range that is naturally occurring in some foods and in water. [12/5/2019]

FDA in Brief Readout of Deputy Commissioner for Food Policy and Response Frank Yiannas’s visit to the Yuma produce growing region The following statement is attributed to Deputy Commissioner Frank Yiannas: “As the food system continues to evolve, the FDA is committed to ensuring innovative food safety approaches that build on past accomplishments and leverage new technologies and analytical tools. Our goal is to create a digital, traceable and smarter food system that streamlines processes while mining a greater amount of information. This week, I had the pleasure of visiting Yuma, Arizona, an important growing region in the U.S. and one that exemplifies our ever changing and complex food system. As we continue to implement the Produce Safety Rule established by the FDA Food Safety Modernization Act (FSMA), it is vital to discuss critical food safety issues with leaders and stakeholders, including growers, to ensure the safety of produce in general, and more specifically, fresh leafy greens. [12/06/2019]

Request for Comment Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS): Establishing Effectiveness of Drugs for Treatment Guidance for Industry by 02/03/2020 This guidance provides recommendations for establishing effectiveness for drugs intended to treat patients with interstitial cystitis/bladder pain syndrome (IC/BPS). This guidance incorporates recommendations the FDA received at a December 2017 advisory committee meeting on trial design features, including enrollment criteria and acceptable effectiveness endpoints for drugs intended to treat IC/BPS. Development of Locally Applied Corticosteroid Products for the Short-Term Treatment of Symptoms Associated with Internal or External Hemorrhoids Guidance for Industry by 02/07/2020

The purpose of this guidance is to assist sponsors in the clinical development of locally applied corticosteroid products (including suppositories or products that require an applicator) for the short-term treatment of symptoms associated with internal or external hemorrhoids. Specifically, this guidance describes FDA’s current thinking regarding the recommended attributes of patients for enrollment, efficacy assessments, and safety assessments.

Public Meetings and Workshops Electronic Submission of Adverse Event Reports to FDA Adverse Event Reporting System (FAERS) using International Council for Harmonisation (ICH) E2B(R3) Standards Date: February 19, 2020 Time: 9:00 a.m. to 4:00 p.m. EST Agenda: The purpose of these public meetings is to provide the pharmaceutical industry and other interested parties with information on the plans, progress, and technical specifications to upgrade electronic submission standards for the premarket and postmarket safety surveillance programs managed by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). These meetings will focus on enhancements to electronic submission of Individual Case Safety Reports (ICSRs) in FAERS using ICH E2B(R3) standards. Register for Meeting Facilitating End-to-End Development of Individualized Therapeutics Date: March 3, 2020 Time: 8:30 a.m. to 5:00 p.m. EST Agenda: The purpose of the public workshop is to foster development of individualized therapeutic products for the treatment of one individual or a very small number of patients, based on engineering a product aimed at the specific molecular mechanism underlying a patient’s (or small group of patients’) illness. Register for Meeting

Recall and Safety Information Public Safety Alert Due to Marketing of Unapproved Stem Cell and Exosome Products FDA is informing the public, especially patients, health care practitioners, and clinics, of multiple recent reports of serious adverse events experienced by patients in Nebraska who were treated with unapproved products marketed as containing exosomes. FDA is carefully assessing this situation along with our federal and state partners. Certain clinics across the country, including some that manufacture or market illegal “stem cell” products, are now also offering exosome products to patients. They deceive patients with unsubstantiated claims about the potential for these products to prevent, treat or cure various diseases or conditions.[12/9/2019] FDA underscores that consumers should not use drugs, dietary supplements and devices recalled from Basic Reset and Biogenyx following consent decree for federal violations FDA is alerting consumers of a recall of 25 drug, dietary supplement and medical device product lines distributed by Basic Reset and Biogenyx of Hendersonville, Tennessee. In September, a federal court entered a consent decree of permanent injunction between the United States and the two companies and their owner, Fred R. Kaufman III. Under the consent decree, Basic Reset and Biogenyx must recall and stop distributing products until the companies comply with the Federal Food, Drug, and Cosmetic Act and other requirements listed in the consent decree.

Consumer Updates Having Naloxone on Hand Can Save a Life During an Opioid Overdose Anyone can save a life during an opioid overdose with naloxone, a front-line defense in the nation's opioid crisis. Naloxone is a life-saving drug that, when sprayed into the nose or injected, quickly reverses the powerful effects of opioids during an overdose. Everyone who overdoses with opioids, whether it is with a prescribed medicine or an illicit drug, needs naloxone. Examples of opioids include heroin, fentanyl, oxycodone, hydrocodone, codeine, and morphine. Because overdoses can happen anywhere, naloxone is designed to be used by anyone, even a bystander. That’s one of many reasons the U.S. Food and Drug Administration (FDA) is working to help increase access to naloxone in case of such an emergency.