Temporary Reshuffle at FDA's Office of Generic Drugs as Leader Takes Medical Leave

The US Food and Drug Administration's (FDA) top generic drug regulator, Kathleen "Cook" Uhl, is temporarily stepping down to deal with a serious health issue, FDA has confirmed.

Uhl has served as head of OGD for two years, first as acting director starting in March 2013, and then as the office's permanent director in January 2015.

Under her leadership, OGD has been implementing huge changes spurred by the passage of the Food and Drug Administration Safety and Innovation Act's (FDASIA) Generic Drug User Fee Act (GDUFA). The law created new funding arrangements meant to allow OGD to hire hundreds more regulatory staff members, but also required the agency to make sustained improvements in its regulatory review times and processes.

But as first reported by former acting deputy director of OGD, Bob Pollock, Uhl is taking medical leave at the end of March.

Uhl is being treated for colorectal cancer and will be on leave for "several months" effective 30 March 2015, FDA told Regulatory Focus in an emailed statement.

In her absence, OGD will be lead on an acting basis by John peters, now the acting director of the Office of Bioequivalence. As reported by Regulatory Focus in February, OGD does not currently have a deputy director to succeed Uhl in her absence.

Dale Conner will become acting director of the Office of Bioequivalence, FDA said.

Regulatory Focus wishes Uhl a speedy recovery.