At last year's House Oversight Committee hearings on J&J's manufacturing problems and recalls, FDA was represented by Principal
Deputy Commissioner Joshua Sharfstein. He won plaudits for having command of the issues and for answering questions directly,
a performance that benefited from earlier experience on Capitol Hill as an aide to Rep. Henry Waxman (D-CA). Now someone else
at FDA will have to fill the hot seat at Congressional hearings following Sharfstein's surprise departure from the agency
Sharfstein was lured away by an offer to head Maryland's health department, a move that capitalizes on his public health roots
as Baltimore's health commissioner before coming to FDA. In moving to the state agency, Sharfstein will manage a $7-billion
budget—which is much bigger than FDA's. He also will be involved with implementing the many healthcare-reform programs and
policies that require state involvement, including an expansion in Medicaid and formation of new health insurance exchanges.
At FDA, Sharfstein helped to engineer a get-tough compliance policy designed to eliminate perceptions that FDA had become
too cozy with industry. This stronger enforcement stance has produced more Warning Letters that cite manufacturing and marketing
violations and more criminal investigations, trends that are likely to continue. He also was involved in strengthening FDA's
medical-device regulatory process, a high-profile exercise that is still ongoing, and he was a strong advocate for ensuring
drug safety and establishing tight curbs on the use of more risky medicines, such as GlaxoSmithKline's diabetes drug Avandia
Hamburg is using Sharfstein's departure as an opportunity to re-examine the agency's top management structure. Previous commissioners
have tried various senior-staff arrangements, with deputy commissioners, chiefs of staff, and special assistants, and Hamburg
may move away from the current one-deputy plan.
Counselor to the Commissioner John Taylor is filling Sharfstein's shoes while the commissioner weighs her options, and he
is expected to assume a more visible role at the agency in the future. Taylor has had a long career at FDA in legal, enforcement,
and regulatory affairs positions under several FDA commissioners during both Democratic and Republican administrations. He
rose to be associate commissioner for regulatory affairs from 2002 to 2005 and then served brief stints at Abbott Laboratories
and with the Biotechnology Industry Organization. Taylor returned to FDA in 2009 to be Hamburg's top legal advisor, and the
commissioner might well prefer to have such a seasoned enforcement official represent FDA before Congressional committees
probing enforcement and safety issues.