FDA Names Acting Head of Generic Drugs Office

FDA Names Acting Head of Generic Drugs Office

March 20th, 2013 // 3:52 pm @

Tomorrow – The Quality Manager Gets Fired and the $125,000 Compliance SNAFU

FDA has named Dr Kathleen Uhl acting director of itsgeneric drugs division as it implements the biggest revamp of the department in more than a decade.

Uhl replaces Dr Gregory Geba, who resigned abruptly last week after just eight months on the job, saying the reorganization will change the scope and responsibilities of the office in a way that no longer made his position attractive.

Uhl was previously Geba’s senior adviser, according to Dr Janet Woodcock, director of the FDA’s drugs division, who announced the news in a memo to staff.

In his own farewell memo to staff, Geba said that over the past five months, since the agency began collecting fees from generic drugmakers to speed up drug reviews, the office approved nearly 200 applications and sent back 600 more, reducing the backlog of pending applications to 2,166 from 2,762.

The realignment, whose details are still being finalized, is designed to sharpen the agency’s focus and “bolster our resources around pharmaceutical quality,” according to a September note to staff from Woodcock.

Generic drugmakers are unsettled by the changes.

In a statement last week, the Generic Pharmaceutical Association (GPhA) said it was “disappointed” to learn of Geba’s departure from the office of generic drugs (OGD).

“Today, 80 percent of prescriptions dispensed in America are generics,” the organization said, adding that it and its members “rely on the strength and continuity of the OGD on critical matters such as regulations governing the entry to market of new, cost-saving generic versions of critical medicines.”

Geba’s departure is particularly jarring since it took the FDA two years to find a permanent replacement for the previous director of OGD, Gary Buehler, who left in late 2010 to become vice president for regulatory strategic operations at Teva Pharmaceutical Industries Ltd, the world’s biggest generic drugmaker.

“These vacancies and changes hold the potential to distract from the critical mission of the OGD,” GPhA said, “and slow the flow of information, guidance, and approvals.”

Uhl, who obtained a medical degree from the Medical College of Pennsylvania, joined the FDA in 1998 in a clinical pharmacology division. She spent five years as assistant commissioner for women’s health and as director of FDA’s Office of Women’s Health.

In 2010, Uhl became deputy director in the office of medical policy. Woodcock said in her memo to staff that Uhl provided “exemplary leadership” of that office as it underwent a major organizational change by becoming a “Super office,” or one that houses subordinate offices.

Part of the current realignment of the generic drugs office involves it too becoming a “Super Office.”

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