Alerts

FDA and Pharmacy Weekly Digest - October 8

Alerts / October 8, 2019
Food/Dietary Supplements

FDA Releases Report on Foodborne Illnesses – The FDA posted a report titled “Foodborne illness source attribution estimates for 2017 for Salmonella, Escherichia coli O157, Listeria monocytogenes, and Campylobacter using multi-year outbreak surveillance data, United States.” The report “estimates the degree to which four pathogens – Salmonella, E. coli O157, Listeria monocytogenes, and Campylobacter – and specific foods and food categories are responsible for foodborne illnesses. The Centers for Disease Control and Prevention (CDC) estimates that, together, these four pathogens cause 1.9 million foodborne illnesses in the U.S. each year.”

FDA Publishes FSVP Record Requirements – The FDA made a list of records required to be kept under the Foreign Supplier Verification Programs (FSVP) available. The list of records is available here.

Drugs/Biologics

FDA Approves Second HIV Prevention Drug – The FDA announced the approval of a second prevention medication for “at-risk adults and adolescents weighing at least 35kg for HIV-1 pre-exposure prophylaxis (PrEP) to reduce the risk of HIV-1 infection from sex.”

FDA to Hold a Vaccines and Related Biological Products Advisory Committee Meeting – The committee “will meet in open session to hear an overview of the research programs in the Laboratory of Hepatitis Viruses (LIR) and the Laboratory of Vector-Borne Viral Diseases (LVVD), Division of Viral Products, Office of Vaccines Research and Review, CBER, FDA. Also, on October 9, 2019, under topic II, the committee will meet in open session to discuss and make recommendations on the selection of strains to be included in an influenza virus vaccine for the 2020 southern hemisphere influenza season.”

FDA Publishes Guidance on Patient-Focused Drug Development – The FDA released a guidance titled “Patient-Focused Drug Development: Methods to Identify What Is Important to Patients Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders.” The guidance is part of a “series of four methodological patient-focused drug development (PFDD) guidance documents that the FDA is developing to describe in a stepwise manner how stakeholders (patients, researchers, medical product developers and others) can collect and submit patient experience data and other relevant information from patients and caregivers to be used for medical product development and regulatory decision-making.”

Medical Devices

FDA Issues Warning About Cybersecurity Vulnerabilities in Medical Devices – The FDA warned patients and healthcare providers “of a set of cybersecurity vulnerabilities, referred to as ‘URGENT/11,’ that—if exploited by a remote attacker—may introduce risks for medical devices and hospital networks. URGENT/11 affects several operating systems that may then impact certain medical devices connected to a communications network, such as wi-fi and public or home Internet, as well as other connected equipment such as routers, connected phones and other critical infrastructure equipment. These cybersecurity vulnerabilities may allow a remote user to take control of a medical device and change its function, cause denial of service, or cause information leaks or logical flaws, which may prevent a device from functioning properly or at all.”

Tobacco

FDA Releases Statement on THC Vaping Products – The FDA announced the publication of a consumer alert “stating that [consumers] should not use vaping products containing tetrahydrocannabinol (THC), the primary psychoactive component of the cannabis plant. Additionally, consumers who choose to use any vaping products should not modify or add any substances such as THC or other oils to products purchased in stores and should not purchase any vaping products, including those containing THC, off the street or from other illicit channels.”

Pharmacy

Michigan Medicaid Program Proposes to Transition Pharmacy Drug Coverage to FFS – The Michigan Medicaid Program issued a Proposed Policy Draft to “inform providers that outpatient prescription drugs will no longer be covered as a part of the Medicaid Health Plan (MHP) benefit. Effective December 1, 2019, all pharmacy drug coverage will be transitioned to Fee-for-Service (FFS) Medicaid. This change is being made pursuant to the implementation of Enrolled Senate Bill 139, which makes appropriations for the Michigan Department of Health and Human Services (MDHHS) for the fiscal year ending September 30, 2020, and will result in cost savings through a combination of increased pharmaceutical rebates and elimination of related MHP administrative capitation costs. The transition to a single formulary will also result in significantly streamlined administration for Michigan’s health care providers and coverage consistency for program beneficiaries. Effective for service dates on or after December 1, 2019, all prescription drugs should be billed at point-of-sale directly to MDHHS’ contracted Pharmacy Benefit Manager (PBM). These medications will be subject to current FFS pharmacy policies and coverage limitations, including prior authorization (PA) requirements.”

Authorship Credit: Lindsay P. Holmes

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