FDA Stakeholder Update - June 28, 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.

Press Announcements

FDA issues warnings to companies selling illegal, unapproved kratom drug products marketed for opioid cessation, pain treatment and other medical uses FDA issued warning letters to two marketers and distributors of kratom products – Cali Botanicals of Folsom, California, and Kratom NC of Wilmington, North Carolina – for illegally selling unapproved, misbranded kratom-containing drug products with unproven claims about their ability to treat or cure opioid addiction and withdrawal symptoms. The companies also make claims about treating pain, as well as other medical conditions like depression, anxiety and cancer.[06/25/2019]

FDA Voices

Forward Into the Past With FDA’s New History Exhibit; by Ned Sharpless, M.D., Acting Commissioner History was made today at the U.S. Food and Drug Administration (FDA). That may not sound like news, since the Agency takes important actions every day that impact the health and safety of the American public. But today, it is a big deal because the Agency unveiled its first permanent exhibit documenting the FDA’s history at the White Oak headquarters in Silver Spring, MD.  In such a fast-paced, forward looking, science-based Agency as the FDA, we don’t often take the time or have the opportunity to look back at our history. [06/25/2019]

FDA In Brief

FDA takes new step to help advance the transition of certain biological products FDA issued a proposed rule to amend its regulations on the use of master files for biological products. The proposed rule, if finalized, would allow certain applications for biological products approved under the Federal, Food, Drug, and Cosmetic Act to continue incorporating by reference information on drug substances, drug substance intermediates, or drug products contained in drug master files (DMF) after the approved applications for those products are deemed to be licenses under the Public Health Service Act (PHS Act) on March 23, 2020. The proposed rule would also codify the FDA’s existing practice that an application for a biological product under the PHS Act may rely on a master file, except for information on drug substances (active pharmaceutical ingredient, or API), drug substance intermediates (a material produced during steps of the processing of an API that undergoes further molecular change or purification before it becomes an API), or drug products (finished dosage forms, such as tablets or capsules). [06/27/2019] FDA seeks to advance safe and effective prostate tissue ablation devices by outlining clinical study recommendations for manufacturers The FDA issued a draft guidance to provide recommendations for device manufacturers regarding the clinical testing that must be conducted in accordance with special controls for high intensity ultrasound systems for prostate tissue ablation devices regulated under the agency’s 510(k) premarket notification program. This draft guidance also outlines recommended clinical data to support marketing submissions for prostatic tissue ablation devices that use newer, more innovative technologies or forms of energy to ablate (or destroy) prostate tissue. [06/25/2019] FDA seeks public feedback on new drug approval transparency efforts FDA issued a Federal Register notice, New Drugs Regulatory Program Modernization: Improving Approval Package Documentation, to open a docket for public comment as part of the agency’s continuous assessment of the efficiency and transparency of the clinical data used in the regulatory decision-making process for drug and biological products assessed by the FDA’s Center for Drug Evaluation and Research (CDER). The notice specifically asks for feedback on the Clinical Data Summary Report (CSR) Pilot Program and the new integrated review of marketing applications process and documentation template. [06/26/2019]

Public Meetings

FDA Public Meeting: Limited Population Pathway for Antibacterial and Antifungal Drugs Meeting Date: July 12, 2019 Meeting Time: 9:00 am EDT - 3:00 pm EDT Register: Online by July 1, 2019 before 5:00 pm EDT The purpose of the meeting is to provide a public forum for FDA to listen to comments on the draft guidance for industry, “Limited Population Pathway for Antibacterial and Antifungal Drugs,” that was published in the Federal Register on June 13, 2018. FDA is also reopening the comment period on this draft guidance for comments to be submitted for consideration before we finish work on the final version of the guidance.

FDA Public Meeting: Endpoints for Drug Development in Heart Failure Meeting Date: July 26, 2019 Meeting Time: 9:00 am EDT - 4:00 pm EDT Register: Online by July 24, 2019 The purpose of this 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.

Safety Information

FDA warns patients and health care providers about potential cybersecurity concerns with certain Medtronic insulin pumps FDA is warning patients and health care providers that certain Medtronic MiniMed insulin pumps are being recalled due to potential cybersecurity risks and recommends that patients using these models switch their insulin pump to models that are better equipped to protect against these potential risks. To date, the FDA is not aware of any confirmed reports of patient harm related to these potential cybersecurity risks. [06/27/2019]

Recalls of Angiotensin II Receptor Blockers (ARBs) including Valsartan, Losartan and Irbesartan Find up-to-date information about recalls of blood pressure medications: valsartan, losartan, and irbesartan. [06/27/2019]

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.