Challenges, Changes, Commitments - Pharmaceutical Executive


Challenges, Changes, Commitments
The Three Cs could be taxing on FDA resources as the new Congress brings stiffer oversight and leadership revisions to the agency

Pharmaceutical Executive

Changes at FDA

At last year's House hearings on J&J's manufacturing problems, FDA was represented by principal deputy commissioner Joshua Sharfstein, who won plaudits for his command of the issues and forceful responses to questions. 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. In shifting to the state agency, Sharfstein will manage a $7 billion budget and will be involved with implementing the many health reform policies, such as Medicaid expansion and formation of new health insurance exchanges.

At FDA, Sharfstein helped engineer a get-tough compliance policy designed to curb perceptions that FDA was too cozy with industry. The stronger enforcement stance has produced more warning letters citing marketing and manufacturing violations, along with more criminal investigations of industry. Sharfstein also was involved in reassessing FDA's medical device approval process, a high-profile exercise that remains ongoing, and he was a strong advocate for drug safety and 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 organizational models, with various deputy commissioners and chiefs of staff, and Hamburg may move away from the one-deputy arrangement.

Counselor to the commissioner John Taylor is filling Sharfstein's shoes while Hamburg weighs her options, and he is likely 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 very well prefer to have a seasoned enforcement official to respond to Congressional probes of regulatory and safety issues.

More Transparency

One of Sharfstein's last officials acts at FDA was to unveil the third phase of the agency's transparency initiative, a program he headed as chair of its Transparency Task Force. Launched in June 2009, the initiative has created an "FDA Basics" Web page, which posts broad information on agency operations. Another innovation is FDA-TRACK, which provides measures of the performance and accomplishments of multiple agency offices and operations.

The latest segment of the project aims to provide regulated companies with helpful material on FDA policies and procedures. FDA will post more information on key staffers and meeting presentations and will provide a system to answer industry questions quickly. To improve the drug application review process, FDA will clarify standard procedures for staff meetings with sponsors about applications, the types of notifications provided to industry, such as those for mid-cycle review meetings, and how it informs companies whether the review of an application is on track to meet a target action date. FDA plans to better explain its process for developing new guidances and regulations, but is still reviewing the more complex issue of whether to set specific timelines for guidance development, or how it should handle sponsor requests to appeal agency decisions.

But these new initiatives fail to resolve the most contentious disclosure proposals, which are still under task force review. A May 2010 report on phase two of the transparency campaign sought comments on proposals to make public a broad range of confidential regulatory information, such as when a manufacturer files an investigational application and whether such an application is put on hold, withdrawn, or terminated (see Pharm Exec, July 2010, page 22). FDA also is considering whether to disclose when a company submits a market application for a new or generic drug or medical device, and if such applications later are withdrawn or abandoned. Most controversial is whether to make public refuse-to-file or complete response letters. And the agency is weighing expanded disclosure of information from adverse event reports, evaluations of imports, plant inspection reports, and product recalls.

Those issues raise "very interesting legal issues" as well as additional resource requirements, Sharfstein explained at his last FDA media briefing. Agency teams are assessing dozens of comments on these proposals. The review is "on track," said Sharfstein, but resolution is not expected anytime soon.

Jill Wechsler is Pharmaceutical Executive's Washington correspondent. She can be reached at


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