FDA to Ban Flavored Tobacco, OIG Audit Criticizes HHS Cybersecurity
The FDA has proposed a total ban on added flavorings in cigarettes and cigars, and a recent OIG audit had some harsh criticism for HHS cybersecurity measures.
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By - Last week, FDA officials continued their campaign against flavored nicotine products with a proposed ban on cigarettes and cigars containing added flavors.
And on the cybersecurity front, the FBI has issued an urgent alert about the ransomware group Blackcat/ALPHV, which has already attacked 60 organizations. At the same time, the OIG found holes in the HHS cybersecurity platform, calling it “not effective” and issuing several recommendations.
VA Stands Firm on $16B EHR Budget
Despite several setbacks, the Department of Veterans Affairs (VA) has not altered its original $16 billion EHR budget. VA Secretary Denis McDonough explained in a recent interview that he believes the project is still operating within its Congressional budget, although a recent report indicates that future delays could lead to billions in additional costs. The Office of the Inspector General (OIG) has already released several reports inferring that the project is extensively underfunded and that the issues with the EHR rollout will balloon the final cost of the IT modernization project. READ MORE.
OIG Calls HHS Security Ineffective
In a recent audit, OIG deemed the HHS cybersecurity program “not effective” and lacking in risk management and contingency planning. The audit was conducted by Ernst and Young LLP and found that HHS was failing to meet maturity levels for four main function areas. The report commented, “HHS is aware of opportunities to strengthen the Department’s overall information security program, which would help ensure that all [operating divisions] are consistently implementing and in line with the requirements across their security programs.” Auditors offered four critical interventions for improving cybersecurity, and HHS has described its plan to address the recommendations. READ MORE.
FDA Proposes Flavored Tobacco Ban
The Food and Drug Administration (FDA) announced a plan to ban all flavored tobacco products, including mentholated cigarettes, as soon as 2023. The ban is part of the Biden Administration’s Cancer Moonshot that aims to reduce cancer deaths by 50 percent. Currently, menthol and flavored tobacco products are disproportionately used by youth and minority groups, making them targets for regulators looking to address social determinants of health. The FDA’s proposed ban is in the open comment period now. READ MORE.
FBI Finds Blackcat/ALPHV Ransomware Indicators
The Federal Bureau of Investigation issued a flash alert warning about a ransomware group that has already compromised 60 organizations worldwide. The FBI cited Blackcat/ALPHV as responsible for a string of new ransomware attacks where hackers infiltrated groups using an ostensibly secure programming language called RUST. “BlackCat/ALPHV ransomware leverages previously compromised user credentials to gain initial access to the victim system. Once the malware establishes access, it compromises Active Directory user and administrator accounts,” the alert explained. The FBI recommends that organizations do a network-wide review of their systems in addition to a full backup of critical information. READ MORE.
FDA Accepts GSK’s Kidney Disease Drug
The Food and Drug Administration (FDA) accepted a New Drug Application for GlaxoSmithKline’s (GSK) chronic kidney disease drug. The drug, Daprodust, performed well in a phase 3 trial, improving hemoglobin target levels without major adverse events. Daprodust is already approved in Japan for patients with renal anemia, and in Europe, the drug is in the authorization pipeline. This product will compete with AtraZenaca’s Farxiga, which has been successful in the treatment of chronic kidney disease. READ MORE.
