Alerts

FDA and Pharmacy Weekly Digest - December 10

Alerts / December 10, 2019
Food/Dietary Supplements

FDA Comments on FSMA Inspections for Small Farms – The FDA announced, “Routine inspections of small farms, other than sprouts operations, subject to the Produce Safety Rule, will generally begin in Spring 2020; however, the FDA is clarifying that states receiving competition A/B funding as part of the State Produce Implementation Cooperative Agreement Program (CAP) may begin routine inspections as early as January 1, 2020. This clarification is being made after several requests from states to have greater flexibility to align routine inspections with the winter growing season where applicable. Individual states will make final decisions on whether to initiate their first routine inspections of small farms at the earlier date in January 2020. States that want to begin routine inspections of small farms, other than sprouts operations, on January 1, 2020, should prioritize completing their planned inspections of large farms subject to the rule before conducting routine inspections of those small farms.”

Drugs

FDA Approves First Generics for Certain MS Treatment – The FDA announced that it “approved three applications for first generics of Gilenya (fingolimod) capsules for the treatment of relapsing forms of multiple sclerosis (MS) in adult patients.”

FDA Comments on Impurities in Diabetes Drugs – In a press release, the FDA stated it “has been investigating the presence of genotoxic impurities, called nitrosamines, in some types of drugs …. 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. While we are aware that some regulatory agencies outside the U.S. may be recalling some metformin drugs, there are no metformin recalls affecting the U.S. market at this time. The FDA is investigating whether metformin in the U.S. market contains NDMA, and whether it is above the acceptable daily intake limit of 96 nanograms. The agency will also work with companies to test samples of metformin sold in the U.S. and will recommend recalls as appropriate if high levels of NDMA are found. If as part of our investigation, metformin drugs are recalled, the FDA will provide timely updates to patients and health care professionals.”

FDA Warns Companies Selling Unapproved Umbilical Cord Blood Products – The FDA sent warning letters to several companies citing the sale of unapproved products derived from umbilical cord blood and deviations from current good tissue practices and current good manufacturing practices.

FDA Announces Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee – The meeting, scheduled for Jan. 14, 2020, will discuss “new drug application … for oxycodegol, a new molecular entity full mu-opioid receptor agonist … for the management of chronic low back pain in adult patients with pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The committees will be asked to discuss the safety and efficacy data as well as the overall risk-benefit profile of the product.”

Medical Devices

FDA Launches App for Healthcare Professionals – The app, called CURE ID, is an “internet-based repository that will allow the clinical community to report their experiences treating difficult-to-treat infectious diseases with novel uses of existing FDA-approved drugs through a website, a smartphone or other mobile device. The platform enables the crowdsourcing of medical information from health care providers to guide potentially life-saving interventions and facilitate the development of new drugs for neglected diseases.”

FDA Announces Marketing Authorization for MRSA Bacteria Diagnostic Test – The FDA announced that the “diagnostic test may allow health care professionals to evaluate patients for colonization with MRSA bacteria more quickly than traditional culture-based techniques when such testing is needed.”

FDA Announces Public Workshop on AI in Radiological Imaging – The meeting, scheduled for Feb. 25-26, 2020, will cover “emerging applications of Artificial Intelligence (AI) in radiological imaging including AI devices intended to automate the diagnostic radiology workflow as well as guided image acquisition. The purpose of the workshop is to work with interested stakeholders to identify the benefits and risks associated with use of AI in radiological imaging. We also plan to discuss best practices for the validation of AI-automated radiological imaging software and image acquisition devices. Validation of device performance with respect to the intended use is critical to assess safety and effectiveness.”

Tobacco

The Director of CTP Testifies Before the House Committee on Oversight and Reform – Mitch Zeller, the director of the Center for Tobacco Products, spoke to the Subcommittee on Economic and Consumer Policy on the federal government’s response to the youth e-cigarette usage epidemic. Zeller stated, “Protecting our nation’s youth from the dangers of tobacco products is among FDA’s most important responsibilities, and we will continue to take aggressive steps to make sure tobacco products are not being marketed or sold to kids. These efforts are a cornerstone of our comprehensive approach for the regulation of tobacco and are also the focus of our Youth Tobacco Prevention Plan. FDA’s Youth Tobacco Prevention Plan demonstrates the Agency’s commitment to protecting our children. FDA’s work to protect youth from tobacco products includes compliance and enforcement, public education, regulatory science research, premarket review, and regulatory policy.”

Cosmetics

FDA Testifies Before the House Energy and Commerce Committee – Before the Subcommittee on Health, the director of the Center for Food Safety and Applied Nutrition stated, “the current law does not require cosmetics to be reviewed and approved by FDA prior to being sold to American consumers … FDA evaluates concerns about ingredients or products based on currently available science and data, much of which is publicly available as FDA does not have authority to require companies to provide it with safety, compositional and other relevant information about cosmetics. FDA also supports and conducts research related to cosmetics safety to support our regulatory activities, as allowed by our resources. When we have safety concerns about ingredients we will act swiftly to inform and advise consumers of any identified public health risks. Ensuring the safety of cosmetics is a high priority for us.”

Pharmacy

Senator Grassley Introduces Drug Pricing Reform Bill – Among other things, S.2543, seeks to strengthen PBM transparency requirements and address DIR fees.

HHS Announces Expanded Access to HIV Medications – The U.S. Department of Health & Human Services announced the Ready, Set, PrEP Program, which “makes medications for pre-exposure prophylaxis (PrEP), taken daily to prevent HIV, available at no cost to people without prescription drug insurance coverage.”

Authorship Credit: Lindsay P. Holmes

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