FDA Faces Internal Changes and Challenges - Pharmaceutical Technology

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FDA Faces Internal Changes and Challenges
Food-safety, transparency, and counterfeit-drug growth will tax agency resources.

Pharmaceutical Technology
Volume 35, Issue 2, pp. 26-30

Deputy departs

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 last month.

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 (rosiglitazone).

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.


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