FDA and Pharmacy Weekly Digest - November 5

Alerts / November 5, 2019
Food/Dietary Supplements

FDA, EPA and USDA Team Up to Reduce Food Waste – The agencies announced a “partnership with the Food Waste Reduction Alliance, the latest effort in the Winning on Reducing Food Waste Initiative launched by the three federal agencies in 2018.” The Agencies formalized this partnership through a Memo of Understanding.


FDA Addresses Shortage Root Cause Report – The FDA issued the Drug Shortage: Root Cause and Potential Solutions Report, which “attempts to identify root causes and offer recommendations for government and industry based on insights gleaned from stakeholders in the private and public sectors. These recommendations are intended to help prevent and mitigate future drug shortages. The report focuses on human drugs, but many of the same concerns apply to veterinary medicines used to treat service, companion, and food-producing animals.”

FDA Continues Modernization Efforts – The FDA announced that it “is taking steps towards requiring electronic submission of certain safety reports for products being evaluated by the FDA under an investigational new drug (IND) application into the FDA’s Adverse Event Reporting System (FAERS). The planned process for submissions is outlined in a new draft guidance, and the FDA is also making available supporting technical specification documents. The changes will allow the FDA to access and review both pre- and post-market safety information in the same system and with the same data standard.”

FDA Provides Update on Ongoing Ranitidine Drugs – The FDA announced that “[o]ver the past several weeks, the FDA has been investigating the detection of a contaminant known as N-Nitrosodimethylamine (NDMA) in ranitidine medications.” The FDA stated that it “has tested numerous ranitidine products on the market over the past few months, and today we’re releasing a summary of the results we have to date. Through our testing so far, we have found levels of NDMA in ranitidine that are similar to the levels you would expect to be exposed to if you ate common foods like grilled or smoked meats.”

FDA CDER Director Testifies Before Subcommittee on Health – Janet Woodcock, M.D., testified before the House Committee on Energy and Commerce regarding safeguarding the pharmaceutical supply chain. The director stated, “[U]se of foreign-sourced materials creates vulnerabilities in the U.S. drug supply.” She also stated, “The security of the nation’s drug supply rests on three main factors: freedom from dependence on foreign sources of API, the resilience of our domestic manufacturing base, and the reliability of the facilities that make products for the U.S. market.”

FDA Publishes Guidance on Treatment for Hepatitis D – The draft guidance is intended “to assist sponsors in the clinical development of drugs for the treatment of chronic hepatitis D virus (HDV) infection. Specifically, this guidance addresses the Food and Drug Administration’s (FDA’s) current recommendations regarding the overall development program and clinical trial designs for the development of drugs and biologics to support an indication for the treatment of chronic HDV infection.”

FDA Issues GDUFA Guidance – The draft guidance is intended to “provide stakeholders information regarding FDA’s implementation of the Generic Drug User Fee Amendments of 2017 (GDUFA II) under Title III of the FDA Reauthorization Act of 2017. Because GDUFA II created changes to the user fee program, this guidance serves to provide an explanation about the new fee structure and types of fees for which entities are responsible.”


FDA Holds Public Meeting on Deemed Tobacco Products – The meeting provided “information on the agency’s expectations for tobacco product applications with a particular focus on deemed tobacco products (e.g., cigars, waterpipe, and Electronic nicotine Delivery Systems (ENDS) including e-liquids and electronic cigarettes)[,] including product review policies, procedures, and general scientific principles.”

Medical Devices

FDA Holds Webinar on 513(g) Requests – The FDA held a webinar and Q&A session addressing 513(g) Requests for Information and Custom Device Exemption.


USDA Issues Hemp Rule – The USDA published an Interim Final Rule specifying the rules and regulations to produce hemp. The rule “outlines provisions for the Department of Agriculture (USDA) to approve plans submitted by States and Indian Tribes for the domestic production of hemp. It also establishes a Federal plan for producers in States or territories of Indian Tribes that do not have their own USDA approved plan. The program includes provisions for maintaining information on the land where hemp is produced, testing the levels of delta-9 tetrahydrocannabinol, disposing of plants not meeting necessary requirements, licensing requirements, and ensuring compliance with the requirements of the new part.”

FDA Updates 503B Bulk Drug Substance Lists – The FDA published an updated version of the Category 1, 2 and 3 lists pursuant to the “Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act.”

House Member Introduces Medicare Access Bill – HR 4946 was introduced “To amend title XVIII of the Social Security Act to ensure equal access of Medicare beneficiaries to community pharmacies in underserved areas as network pharmacies under Medicare prescription drug coverage, and for other purposes.”

CMS Finalizes 340B Cuts – The Final Rule “revises the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for Calendar Year 2020 based on our continuing experience with these systems. In this final rule with comment period, we describe the changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment system. Also, this final rule with comment period updates and refines the requirements for the Hospital Outpatient Quality Reporting (OQR) Program and the ASC Quality Reporting (ASCQR) Program. In addition, this final rule with comment period establishes a process and requirements for prior authorization for certain covered outpatient department services; revise[s] the conditions for coverage of organ procurement organizations; and revise[s] the regulations to allow grandfathered children’s hospitals-within-hospitals to increase the number of beds without resulting in the loss of grandfathered status; and provides notice of the closure of two teaching hospitals and the opportunity to apply for available slots for purposes of indirect medical education (IME) and direct graduate medical education (DGME) payments.”

Authorship Credit: Lindsay P. Holmes

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