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Review of Approval Process

The US Food and Drug Administration's controversial approval of Biogen's Alzheimer's disease drug is to be reviewed, Stat News reports.

Acting FDA Commissioner Janet Woodcock called on the Department for Health and Human Services' Office of the Inspector General last month to investigate interactions between FDA staff and Biogen, and the office now says it will be reviewing FDA's accelerated approval pathway.

The approval of aducanumab, Biogen's Aduhelm, was controversial. As Time magazine reported in 2019 Biogen sought approval for the drug after a re-analysis of data from one of its clinical trials suggested it might slow cognitive decline among some patients. But in late 2020, an FDA advisory panel determined there was not enough data indicating the drug worked, and its subsequent approval led to resignations among panel members. One member noted the approval was based on the drug's effect on amyloid in the brain, which the panel was unable to discuss. Stat News further reported previously that the agency worked unusually close with the company on approval and there may have been "off-the-books" meetings between the two.

The OIG says its investigation will include "reviewing interactions between the FDA and outside parties as well as other aspects of the process, such as deciding on this pathway and scientific disputes." The Washington Post notes that the OIG will not examine whether aducanumab is effective.

The Scan

Removal Inquiry

The Wall Street Journal reports that US lawmakers are seeking additional information about the request to remove SARS-CoV-2 sequence data from a database run by the National Institutes of Health.

Likely to End in Spring

Free lateral flow testing for SARS-CoV-2 may end in the UK by next spring, the head of Innova Medical Group says, according to the Financial Times.

Searching for More Codes

NPR reports that the US Department of Justice has accused an insurance and a data mining company of fraud.

Genome Biology Papers on GWAS Fine-Mapping Method, COVID-19 Susceptibility, Rheumatoid Arthritis

In Genome Biology this week: integrative fine-mapping approach, analysis of locus linked to COVID-19 susceptibility and severity, and more.