United States: FDA And Pharmacy Weekly Digest - July 30

Food/Dietary Supplements

FDA Suspends Food Facility Registration – The FDA announced the suspension of a Texas-based seafood producer. The entity is prohibited from selling or distributing any foods because “serious sanitation issues were observed, including several samples confirming the presence of Listeria and pathogenic Listeria monocytogenes (L. monocytogenes).”

Deputy Commissioner Speaks About Smarter Food Safety – The FDA’s deputy commissioner for food policy and response remarked to the International Association for Food Protection, “Smarter food safety isn’t just a slogan or a tagline. It’s much more than that. Instead, it’s a new approach to food safety, a new mindset, one that recognizes and builds on the progress made in the past but incorporates the use of new technologies that are being used in society and business sectors all around us, such as blockchain, sensor technology, the internet of things and artificial intelligence. But smarter food safety is about more than just technology. It’s also about simpler, more effective, and modern approaches and processes. It’s about leadership and creativity.”

Drugs/Biologics

FDA Warns CBD Marketers – The FDA issued a warning letter to a marketer of CBD-containing products that carry “unsubstantiated claims that the products treat cancer, Alzheimer’s disease, opioid withdrawal, pain and pet anxiety, among other conditions or diseases.” The FDA stated that it “continues to be concerned at the proliferation of products asserting to contain CBD that are marketed for therapeutic or medical uses that have not been approved by the FDA. The FDA approval process ensures that drugs on the market are safe and effective for their intended therapeutic uses. CBD is marketed in a variety of product types, such as oil drops, capsules, syrups, teas and topical lotions and creams. Often such products are sold online and are therefore available throughout the country. Other than one prescription human drug product to treat rare, severe forms of epilepsy, the FDA has not approved any other CBD products, and there is very limited information for other marketed CBD products, which likely differ in composition from the FDA-approved product and have not been evaluated for potential adverse effects on the body.”

FDA Issues Guidance on Rare Pediatric Disease Priority Review – The FDA published a draft guidance addressing how the “FDA will award priority review vouchers to sponsors of certain rare pediatric disease product applications that meet the criteria.”

FDA Releases a Guidance Related to Kidney TransplantsThe FDA made a final guidance available intended to “assist sponsors in the clinical development of drugs for the prevention of delayed graft function (DGF) in kidney transplantation. Specifically, this guidance addresses the Food and Drug Administration’s (FDA’s) current thinking regarding the overall development program and clinical trial designs for systemic drugs administered to the kidney transplant recipient to support an indication of prevention of DGF.”

FDA Publishes Guidance on Medicated Feeds – The FDA issued a final guidance related to Blue Bird labels. FDA explained, “Blue Bird labels are created by Type A medicated article sponsors and function as a guide to manufacturers of medicated animal feeds in the preparation of final printed feed labels. The purpose of this guidance is to provide NADA sponsors of Type A medicated articles with FDA’s current thinking on the recommended content and format of Blue Bird labels.”

FDA Withdraws Guidance on Establishment Information Submissions – The FDA announced “withdrawal of the draft guidance for industry Providing Regulatory Submissions in Electronic Format – Submission of Manufacturing Establishment Information, issued in December 2016. The draft guidance, when finalized, was intended to implement section 745A of the Federal Food, Drug, and Cosmetic Act, which requires that drug applications be submitted in an electronic format. It would have also streamlined the review of manufacturing establishments involved in preparing a drug or biological product by consolidating information in one location. After considering the public comments received, FDA has decided to withdraw the draft guidance and reevaluate its approach to submission of manufacturing establishment information in drug applications.”

FDA Warns of Compounded Products Causing Horse DeathsThe FDA issued a warning stating, “The U.S. Food and Drug Administration is alerting horse owners and veterinarians that one lot of a compounded combination drug product containing pyrimethamine and toltrazuril has been associated with adverse events in at least three horses. Two horses in Maine and one in Ohio ultimately died or were euthanized as a result.”

Medical Devices

FDA Requests Breast Implant Recall – The FDA requested that a manufacturer of a specific type of breast implant recall the product because of the risk of breast implant-associated anaplastic large-cell lymphoma.

FDA Takes Steps to Further Lyme Disease Diagnosis – The FDA cleared for marketing four devices for new indications to diagnose Lyme disease. The FDA stated, “The tests cleared today are the first time that a test has been indicated to follow a new testing paradigm in which two tests called enzyme immunoassays (EIA) are run concurrently or sequentially, rather than the current two-step process in which a separate protein test called a Western Blot must be run after the initial EIA test.”

FDA Publishes Guidance About Metal Expandable Biliary Stents – The final guidance “provides recommendations for 510(k) submissions for metal expandable biliary stents and their associated delivery systems. These devices are intended to provide luminal patency of the biliary tree for palliation of malignant strictures. The FDA updated this guidance to reflect current review practices.”

Pharmacy

Senate Finance Committee Takes on Drug Pricing – Members of the committee introduced the Prescription Drug Pricing Reduction Act of 2019, intended to lower prescription drug prices. Members stated, “The cost of many prescription drugs is too high. Without action, we’re on an unsustainable path for taxpayers, seniors and all Americans. A working-class family shouldn’t have to pick between making their rent or mortgage payment and being able to afford their kids’ medications. A single mother with diabetes shouldn’t have to pick between groceries and insulin. A senior citizen who’s paid into the system their entire life shouldn’t have to cut pills in half to be able to make it to the next refill. The time to act on prescription drug prices is now.”

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