August 5, 2021

Around the nation: HHS watchdog to review FDA approval of Aduhelm

Daily Briefing

    HHS' Office of Inspector General will review FDA's accelerated approval process for Biogen's Alzheimer's drug, Aduhelm, in today's bite-sized hospital and health industry news from the District of Columbia, Georgia, Illinois, and Kansas.

    • District of Columbia: HHS' Office of Inspector General (OIG) on Wednesday announced it would review the accelerated approval process FDA used to initially approve Biogen's Alzheimer's drug, Aduhelm. Acting FDA commissioner Janet Woodcock last month asked the federal watchdog to investigate Aduhelm's approval after a STAT News report revealed Biogen and FDA officials had several meetings that "may have occurred outside of the formal correspondence process."According to OIG, it will examine interactions between FDA and "outside parties, as well as other aspects of the process, such as deciding on this pathway and scientific disputes." An OIG spokesperson said the watchdog is "committed to overseeing the integrity of FDA's drug approval process, including the decisions informing how some drugs are selected for the accelerated approval pathway." However, OIG is not expected to complete the review until 2023. (Silverman, STAT News, 8/4)
    • Georgia: CDC on Tuesday said it would extend an eviction moratorium to Oct. 3 in counties with "substantial and high levels of community transmission" of the coronavirus. This extension applies to nearly 90% of all renters and replaces a previous moratorium aimed at all renters that expired July 31. Although President Joe Biden earlier said he wasn't sure whether an extension would "pass constitutional muster," he acknowledged that the moratorium would give states additional time to distribute $46 billion in rental assistance funds from the federal government. According to data from the Treasury Department, only $3 billion of the funds had been distributed by June 30. (Reilly, Roll Call, 8/3)
    • Illinois/Kansas: A report from the American Academy of Pediatrics and the Children's Hospital Association found around 72,000 children tested positive for the coronavirus in the United States last week—up from 39,000 cases among children reported the week before. The report analyzed data from 49 states, New York City, the District of Columbia, Puerto Rico, and Guam. In addition, based on hospitalization and mortality data reported by a smaller portion of states, the report states that "Covid-19-associated hospitalization and death is uncommon in children." The rate of Covid-19 deaths among children in states reporting information was 0% to 0.26%, with seven states reporting zero deaths among children. (Lonas, The Hill, 8/3)
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