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On the Fast Track

A US Food and Drug Administration initiative has sped the review and approval process for promising drugs, but researchers from Wake Forest University Medical School note in the Journal of the American Medical Association that some fast-tracked drugs have been associated with safety risks. Thomas Moore and Curt Furberg focus on three drugs — vandetanib, fingolimod, and dabigatran — that have been approved quickly despite some safety concerns and uncertainty regarding dosing. "Although enabling new drugs with a favorable benefit-to-harm balance to become available to patients more rapidly is a laudable goal, the underlying question is what public health risks are taken when drugs are approved for widespread use while important safety questions remain unanswered," Moore and Furberg write.

At Pharmalot, Ed Silver sought comment on the JAMA essay from FDA. A spokesperson told him that the labels for the drugs discussed by Moore and Furberg discuss when it is appropriate for physicians and patients to turn to those drugs. The spokesperson adds that "making regulatory decisions about drugs always involves uncertainty and risk. FDA works directly with the affected patient populations and treating physicians when considering just how much uncertainty and risk are reasonable to accept."

The Scan

And Back

The New York Times reports that missing SARS-CoV-2 genome sequences are back in a different database.

Lacks Family Hires Attorney

A lawyer for the family of Henrietta Lacks plans to seek compensation from pharmaceutical companies that have used her cancer cells in product development, the Baltimore Sun reports.

For the Unknown

The Associated Press reports that family members are calling on the US military to use new DNA analysis techniques to identify unknown sailors and Marines who were on the USS Arizona.

PLOS Papers on Congenital Heart Disease, COVID-19 Infection Host MicroRNAs, Multiple Malformation Mutations

In PLOS this week: new genes linked to congenital heart disease, microRNAs with altered expression in COVID-19, and more.