Alerts

FDA and Pharmacy Weekly Digest - November 20

Alerts / November 20, 2019
Food/Dietary Supplements

Deputy Commissioner for Policy, Legislation, and International Affairs Gives Remarks at the Food Allergy Summit – The deputy commissioner stated, “Today, allergies are a growing public health and safety concern that affects millions of Americans. While more robust prevalence estimates of clinically confirmed food allergies in the US population are still needed, a 2010 NIH clinical food allergy guidelines found an overall population prevalence of about three percent, but recent studies have suggested a higher prevalence rate, with a rate as high as eight percent in children. A gathering such as this one, which brings together a diverse group of scientists, policy makers, doctors, chefs, health and safety advocates, public figures such as athletes, developers and entrepreneurs, members of the media, and many others can play a very important role in advancing the ball forward in this important public health area. It offers the opportunity to share the latest research and ideas, to focus on, and discuss opportunities for, supporting research into causes and cures, and to address the broad range of challenges that are part and parcel of the symptoms and treatment of allergens.”

Principal Associate Commissioner for Policy Gives Remarks at the Council for Responsible Nutrition Conference – Lowell Schiller remarked, “FDA is strongly committed to upholding our obligation to protect the public from unsafe and unlawful products, and to holding accountable those actors who are unable or unwilling to comply with the requirements of the law. With this in mind, and as we mark DSHEA’s Silver Anniversary, at FDA we’re asking ourselves two questions: First, are we using our existing authorities and resources as effectively and efficiently as possible? Second, given all the evolution we’re seeing in the market, are there statutory changes that would help preserve DSHEA’s essential balance in the modern era?”

Drugs

FDA Issues Warning Letter to Retail for Receiving Unsafe Drugs – The FDA announced that it issued a warning letter to a well-known retailer for receiving over-the-counter (OTC) drugs from foreign manufacturers. The warning letter outlines violation of FDA regulations by contract manufacturers used by the retailer to make these products.

FDA Approves Treatment for Relapsed and Refractory Mantle Cell Lymphoma – The FDA announced the approval of a product “for the treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy.”

FDA Approves Antibacterial Drug for UTIs – The FDA announced the approval of an “antibacterial drug for treatment of patients 18 years of age or older with complicated urinary tract infections (cUTI), including kidney infections caused by susceptible Gram-negative microorganisms, who have limited or no alternative treatment options.”

FDA Approves Treatment for Complication in Patients With Sickle Cell Disease – The product is “a treatment to reduce the frequency of vaso-occlusive crisis – a common and painful complication of sickle cell disease that occurs when blood circulation is obstructed by sickled red blood cells – for patients age 16 years and older.”

FDA Remarks on Biologics Marketplace – The acting director of the Office of Therapeutic Biologics and Biosimilars stated, “Today the FDA took another step to further foster biologics competition with the approval of Abrilada (adalimumab-afzb), a biosimilar to Humira. Today’s approval is one of nine new biosimilar products the FDA has taken action on in 2019, bringing the overall total of biosimilar approvals to 25. I’m pleased to see this progress and am confident that the market for these therapies will continue to grow. To date, 74 programs for 38 different reference products have been enrolled in our Biosimilar Product Development Program to discuss development of proposed biosimilar products or interchangeable products, laying the foundation for ongoing competition in the marketplace.”

Medical Devices

FDA Clears Duodenoscope – The FDA announced the clearance of “the first duodenoscope with a sterile, disposable elevator component that will reduce the number of parts that need to be cleaned and disinfected (reprocessed) in between uses.”

FDA Approves Contact Lens Products – The FDA announced the approval of “the first contact lens indicated to slow the progression of myopia (nearsightedness) in children between the ages of 8 and 12 years old at the initiation of treatment.”

FDA Issues Guidance on Decisions Not to Issue Device Export Certificates – The final guidance addresses “the process afforded to persons denied a Certificate to Foreign Government (CFG) for a device.”

Tobacco

FDA Publishes Information on Modified Risk Tobacco Products – The FDA made an informational page available about modified risk tobacco products, and lists those products that have obtained FDA authorization

FDA Announces New Youth E-Cig Prevention Educational Resources – The agency announced that “the FDA and Scholastic are expanding their collaboration to launch their first middle school resources in addition to new resources for high schools. Last week, the FDA released the results of the 2019 National Youth Tobacco Survey, which shows that more than 5 million U.S. middle and high school students are current e-cigarette users (having used within the last 30 days).”

CDC Updates Public on Vaping Related Lung Illness – The CDC indicated that it “has identified vitamin E acetate as a chemical of concern among people with e-cigarette, or vaping, product use associated lung injury (EVALI). Recent CDC laboratory testing of bronchoalveolar lavage (BAL) fluid samples (fluid samples collected from the lungs) from 29 patients with EVALI submitted to CDC from 10 states found vitamin E acetate in all of the samples. Vitamin E acetate might be used as an additive, most notably as a thickening agent in THC-containing e-cigarette, or vaping, products.”

Pharmacy

FDA Releases Animal Compounding Guidance – The draft guidance is directed at “veterinarians, State-licensed pharmacies, and Federal facilities interested in compounding animal drugs from bulk drug substances for use in nonfood-producing animals or for use as antidotes in food-producing animals under limited circumstances when no other medically appropriate treatment options exist.”

Authorship Credit: Lindsay P. Holmes

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