FDA Stakeholder Update - August 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.

FDA In Brief FDA encourages inclusion of male patients in breast cancer clinical trials The draft guidance, Male Breast Cancer: Developing Drugs for Treatment, includes draft recommendations for inclusion of males in breast cancer clinical trials. Historically, males either have not been included in clinical trials for drugs to treat breast cancer or inclusion of males in those trials has been very limited; when finalized, the draft guidance will provide clarity for industry regarding clinical development of drugs to treat breast cancer in male patients. [August 26, 2019] FDA to hold Pediatric Advisory Committee meeting to discuss safety review of certain drugs in pediatric population “Children are one of our most vulnerable populations of patients and working to ensure that approved drugs are as safe as possible for them is a priority at the FDA. Because they may have different drug responses, toxicity and metabolism than adults, our children deserve access to products that have been appropriately evaluated for them. Without data specific to the pediatric population, there may be insufficient knowledge of the dosing, safety and efficacy of drugs intended for use in children – putting them at risk for negative health impacts or limiting access to the treatments they need,” said Susan McCune, M.D., director of the FDA’s Office of Pediatric Therapeutics. [August 20, 2019] Federal Register: Joint Pediatric Advisory Committee and Drug Safety and Risk Management Advisory Committee Notice – Sept. 26, 2019 Federal Register: Joint Pediatric Advisory Committee and Drug Safety and Risk Management Advisory Committee Notice– Sept. 27, 2019

Request for Comment Tobacco Products; Required Warnings for Cigarette Packages and Advertisements The FDA is issuing a proposed rule to establish new required cigarette health warnings for cigarette packages and advertisements.  The proposed rule would implement a provision of the Family Smoking Prevention and Tobacco Control Act that requires FDA to issue regulations requiring color graphics depicting the negative health consequences of smoking to accompany new textual warning statements. Comment Period End Date: October 15, 2019 Harmful and Potentially Harmful Constituents in Tobacco Products; Established List; Proposed Additions; Request for Comments   The FDA is requesting comments, including scientific and other information, concerning whether additional harmful and potentially harmful constituents (HPHCs) in tobacco products and tobacco smoke should be added to the Agency’s established list of tobacco HPHCs (the HPHC established list). This information will assist the Agency in determining whether any or all of the 19 constituents listed in this document should be added to the HPHC established list. Comment Period End Date: October 04, 2019

FDA Voices Delivering Promising New Medicines Without Sacrificing Safety and Efficacy b y Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research and Peter Marks, M.D., Ph.D., Director, Center for Biologics Evaluation and Research "The FDA walks a fine line. We must balance timely patient access to important new medicines with assuring they meet key standards. These standards exist to make sure that approved drugs have a high chance of helping those who use them. Medicines ultimately must lead to overall improvements in how patients feel, function or survive. Not all diseases have the same impact. Getting a diagnosis of high blood pressure is not like learning that you have an incurable cancer." [August 27, 2019]

Recall and Safety Information Statement on the agency’s ongoing efforts to resolve safety issue with ARB medications, from Director - Center for Drug Evaluation and Research Janet Woodcock M.D. "Protecting patients is the FDA’s highest priority, and Americans can be confident in the quality of the products the agency approves. The recent Angiotensin II Receptor Blocker (ARB) recalls have deeply concerned patients, the medical community, the agency and international regulatory bodies. The FDA is aware many patients rely on ARB medicines, and we are concerned about the presence of nitrosamine impurities in these drugs." [August 28, 2019] FDA warns company for putting consumers at risk with drug manufacturing data integrity violations The FDA posted a warning letter to Ningbo Huize Commodity Co., an over-the-counter (OTC) drug manufacturer, for significant current good manufacturing practice (CGMP) violations, including data integrity issues. “Americans deserve to have confidence in the quality of drugs the FDA regulates – from the prescription medicines they take to the over-the-counter products they use in their daily lives, like toothpaste and sunscreen. Helping assure the quality and safety of these products is one of our greatest responsibilities as a public health agency. In recent years, the FDA has focused additional resources on efforts to prevent, uncover and combat data integrity lapses. We’ve focused comprehensive new efforts on these risks, both through our global inspections program as well as providing updated guidance, and to train our staff on identifying concerns related to data integrity,” said Acting FDA Commissioner Ned Sharpless, M.D. [August 20, 2019]