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7/30/2021

The FDA's Center for Drug Evaluation and Research sent an untitled letter to online retailer Amazon for misbranding drugs and marketing unapproved drugs in violation of certain sections of the Federal Food, Drug and Cosmetic Act. In a letter sent to Amazon CEO Andy Jassy, the FDA said it identified 26 weight loss and sexual enhancement products being sold on Amazon that contained one or more of the active pharmaceutical drug ingredients tadalafil, sildenafil or vardenafil, that were not declared on the labeling of the products.

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Regulatory Focus
7/30/2021

Charles Adams Jr. from Dobson, N.C., pleaded guilty to one count of conspiring to use the DEA registration number of another provider to prescribe controlled substances, among other counts. Court documents showed Adams, who worked as a counselor for a company that operated Virginia-based medical clinics, influenced medical decisions and treatments of patients, which included the prescribing of Suboxone and Schedule II pain medications.

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Department of Justice
7/30/2021

A study presented at the Alzheimer's Association International Conference suggests that high sugar intake might increase a person's risk of developing Alzheimer's disease. "Most sugars readily convert to glucose, whose metabolism is regulated by insulin and the insulin-mediated glucose transporter GLUT4, which is highly expressed in the hippocampus and may play a role in memory," researcher Christopher Ford said.

7/30/2021

US Surgeon General Vivek Murthy said the US must do everything possible to increase COVID-19 vaccination rates as the Delta variant continues to fuel infections across the country, particularly in areas with low vaccination coverage. States that have fully vaccinated fewer than 50% of residents are seeing almost triple the hospitalization rates and more than double the COVID-19 infection and death rates, on average, compared with states where more than half of residents have been vaccinated.

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CNN
7/30/2021

Eli Lilly's baricitinib was granted expanded emergency use authorization by the FDA as a COVID-19 drug that can be administered separately from Gilead's remdesivir. The expanded authorization was based on results from a trial involving 1,525 hospitalized COVID-19 patients that showed those treated with baricitinib had a lower risk of progressing to ventilator use or death compared with patients given standard of care.

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Reuters
7/30/2021

Financial advisors looking to get and keep clients' children with their company can take a page from health insurers and offer free services until age 26, writes Samantha Russell of FMG Suite. She recommends tailoring services to the children's needs, setting parameters on free offerings and being clear about what will change at age 26.

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WealthManagement
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Samantha Russell
7/30/2021

US lawmakers reintroduced legislation to allow Medicare beneficiaries greater access to chronic care management, including care plans and medication provisions. "It's unfortunate so few seniors access this benefit, and I believe dropping the cost-sharing requirements will change that," said Rep. Suzan DelBene, D-Wash., a lead sponsor of the Seniors' Chronic Care Management Improvement Act.

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FierceHealthcare
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Rep. Suzan DelBene
7/30/2021

The FDA has allowed Emergent BioSolutions to resume production of the drug substance used in Johnson & Johnson's COVID-19 vaccine at its previously troubled plant, although the facility has yet to be fully authorized by the FDA and individual lots of vaccines still need to be inspected by the agency prior to shipment and administration, according to an unnamed administration official.

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CNN
7/30/2021

Confirmatory evidence of clinical efficacy is lacking on 112 of 253 drugs the FDA has approved through an accelerated pathway, and some of them have been on the market for more than 20 years, according to an article in The BMJ. "Despite the pathway's good intentions to accelerate 'the availability of drugs that treat serious diseases,' experts are concerned that it is now being exploited, to the detriment of patients -- who may be given a drug that offers little benefit and possible harm -- and of taxpayers," author Elisabeth Mahase wrote.

7/30/2021

Debbie Moore of Springfield, Mass., was sentenced to five years of supervised release and was ordered to pay $261,933 in restitution after pleading guilty to one count of government theft. Authorities said the Social Security Administration deposited $261,933 in social security retirement benefits intended for Moore's relative into a bank account controlled by Moore after the relative died in 2003.

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Department of Justice