Stakeholder Engagement Update - April 5, 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. A few notable items were issued this week, including:

FDA In Brief: FDA proposes updated standards for fluoride added to bottled water to maximize health benefits while avoiding excess exposure - FDA released a proposed rule, “Proposed Rule to Revise the Allowable Level of Fluoride in Bottled Water to which Fluoride Has Been Added,” to lower the allowable level of fluoride in bottled water to which fluoride is added by the manufacturer to 0.7 mg/L to be consistent with the 2015 recommendation by the U.S. Public Health Service (PHS) for community water systems that add fluoride for the prevention of dental caries.

FDA Voices: Understanding the Health Impact and Dangers of Smoke and 'Vapor' - By: Scott Gottlieb, M.D., Commissioner, and Amy Abernethy, M.D., Ph.D., Principal Deputy Commissioner For years, we’ve known that cigarette smoke is a major cause of death and disease, a source of many different cancers, cardiovascular and pulmonary illnesses, and numerous other serious health problems. Tobacco smoke harbors more than 7,000 chemicals, at least 70 of which are directly linked to cancer.

FDA Press Releases April 04, 2019 - FDA and CBP bolster collaboration to protect public health and safety April, 3, 2019 - FDA’s continued efforts to stop stem cell clinics and manufacturers from marketing unapproved products that put patients at risk, while progressing the agency’s commitment to help advance legitimate stem cell product development under existing agency regulations April 03, 2019 - Statement from FDA Commissioner Scott Gottlieb, M.D. and Deputy Commissioner Anna Abram on new 2019 efforts to improve the quality of compounded drugs April 02, 2019 - Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to advance agency’s continued evaluation of potential regulatory pathways for cannabis-containing and cannabis-derived products April 02, 2019 - FDA takes new enforcement actions as part of the agency’s ongoing effort to combat the illegal online sales of opioids April 02, 2019 - Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s continued efforts to bring competition to the insulin market to lower prices and expand access April 01, 2019 - FDA warns homeopathic firms for putting patients at risk with significant violations of manufacturing quality standards April 01, 2019 - Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to advance treatment strategies for helping youth addicted to nicotine as a result of the epidemic rise in teen use of e-cigarettes

FDA In Brief: FDA affirms its commitment to efficient adoption of Risk Evaluation and Mitigation Strategy plans and to making sure they do not impede generic drug development - Risk management is a critical function of the work that we do at the FDA to ensure the benefits of FDA-approved drugs and products outweigh the risks. One of the tools that we use in making sure that drugs have an appropriate benefit-risk balance is a Risk Evaluation and Mitigation Strategy (REMS). This is a drug safety program that the FDA can require for certain medications with serious safety concerns.

Discussion Paper: Artificial Intelligence and Machine Learning in Software as a Medical Device - Artificial intelligence and machine learning technologies have the potential to transform health care by deriving new and important insights from the vast amount of data generated during the delivery of health care every day. Medical device manufacturers are using these technologies to innovate their products to better assist health care providers and improve patient care. The FDA is considering a total product lifecycle-based regulatory framework for these technologies that would allow for modifications to be made from real-world learning and adaptation, while still ensuring that the safety and effectiveness of the software as a medical device is maintained.

Fact or Fiction: What to Know About Smoking Cessation and Medications - Tobacco use is the leading preventable cause of death in the United States, resulting in more than 480,000 deaths annually. Almost 70 percent of current smokers report wanting to quit smoking, but quitting can be hard and often takes multiple attempts. A variety of FDA-approved medications are available to help people successfully quit smoking. During a January 26, 2018 FDA public hearing focused on FDA’s approach to evaluating nicotine replacement therapies, we heard concerns about misperceptions around smoking cessation medications and we want to help separate fact from fiction.

Mammography: What You Need to Know - Mammograms continue to be the best primary tool for breast cancer screening. The FDA, along with some FDA-approved state agencies, certify facilities to perform mammography; and the FDA clears and approves new mammography devices for sale in the U.S. Congress enacted the Mammography Quality Standards Act (MQSA) in 1992 to ensure all women have access to quality mammography for the detection of breast cancer in its early, most treatable stages.

Impact Story: Transitioning a Powerful Analytical Tool into Manufacturing to Improve the Quality of Complex Therapeutics - CDER researchers are evaluating an approach that would harness the potential of mass spectrometry to ensure the quality of complex protein therapeutics to treat cancer and other diseases. Mass spectrometry (MS) is a powerful analytical tool used in nearly all protein-based biologics license applications as a characterization method to assess a wide variety of protein attributes, including molecular mass, amino acid sequence, and critical chemical modifications.