* Dr Kathleen Uhl to replace Dr Gregory Geba
* Geba abruptly resigned last week
* Generic drug trade group has concerns about revamp
By Toni Clarke
March 19 The U.S. Food and Drug Administration
has named Dr Kathleen Uhl acting director of its generic 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
"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."