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12:00 AM
Jan 10, 2011
 |  BioCentury  |  Politics, Policy & Law

After Sharfstein

FDA's Hamburg starts 60-day organizational review as Sharfstein departsHouse Republicans ready FDA investigations; hire industry-friendly staff

Principal Deputy Commissioner Joshua Sharfstein's unexpected exit from FDA has prompted Commissioner Margaret Hamburg to launch a 60-day organizational review. Drug developers will want to see whether Commissioner Hamburg is really going to tackle the hard issues.

The review is intended in part to redistribute Sharfstein's portfolio, unwind bureaucratic rivalries, and eradicate the impression that the agency was operating with two heads, according to senior FDA officials who would not speak for attribution.

These kinds of process changes may make it easier to manage the agency, but from the perspective of companies developing medical products, they will only be successful if they address critical issues industry believes have erected roadblocks to product approvals.

Biotech and pharmaceutical companies, and investors, have concluded that FDA's default response to NDAs and BLAs is to send complete response letters rather than approving new therapies on a first review cycle.

Sponsors want clarity and consistency in the review process, including on approval endpoints, which they think have all too often shifted during clinical programs. And they want risk evaluation and mitigation strategies (REMS) integrated into reviews in ways that do not delay approvals.

Overall, companies want to know if Hamburg will change a culture they think encourages reviewers to continually add new safety requirements while raising the bar for demonstrating efficacy.

Thus, from industry's point of view, to be meaningful the organizational reset will have to create a more collaborative approach to product development that integrates strict and predictable regulatory standards, scientific expertise, medical realities and patient needs.

Hamburg's organizational review comes at a time when industry's concerns will be a higher priority to Republicans who control the House of Representatives (see "Red Shift in the House," A29).

Changing the culture

Sharfstein, who was appointed to his post in March 2009, involved himself in complex issues throughout FDA, and was a primary point of contact for a broad range of external stakeholders, Capitol Hill and White House staff, and journalists.

Sharfstein led FDA's Transparency Task Force, which made its final set of recommendations last week. Those recommendations were intended to make FDA activities less opaque to industry, but included no major changes in agency procedures (see Online Links, A41).

Nevertheless, during his tenure, Sharfstein set a precedent for using disclosure to highlight the agency's deliberative processes (see BioCentury, Oct. 10, 2010).

Sharfstein played...

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