A revolving door inside the FDA has captured the attention of a group of Republican lawmakers in Congress. Just a few months after Leona Brenner-Gati was named Acting Deputy Commissioner for Medical Products and Tobacco to replace the outgoing Steven Spielberg, who served only a brief stint at the post, Brenner-Gati is gone as well. And the lawmakers are demanding that FDA Commissioner Margaret Hamburg detail exactly what she did there as well as the circumstances behind the sudden exit.
|FDA Commissioner Margaret Hamburg|
As a report from the Regulatory Affairs Professional Society noted at the time, Spielberg--a veteran academic researcher--was brought in to help address the development of regulatory science, a major initiative that was intended to bring the agency up to speed with the industry. Spielberg left abruptly and Brenner-Gati stepped into his spot. Now the lawmakers have spelled out a series of queries about Brenner-Gati, whose resignation was announced on May 3.
The Republicans are asking Hamburg to detail just what she was doing in the few months she held the title, according to a report from Reuters, noting there were no "significant" meetings on the calendar. Their letter says FDA records "raise questions about whether she was actively working in her position over the last two months, and the circumstances surrounding her resignation."
The lawmakers suspiciously note that Brenner-Gati was conspicuously absent from FDA records on its senior officials, or even the agency directory in the days before her announced departure. And they want to know about all of Brenner-Gati's "significant accomplishments" cited by Hamburg in an internal memo.
Brenner-Gati held senior positions at J&J ($JNJ) before joining the FDA last year. According to her bio at the Alliance of Regenerative Medicine, where she was a founding member, Brenner-Gati helped create BetaLogics, which was working on a stem cell therapy for diabetes. And J&J looked to her to identify new technologies that could be used in the metabolics field.
- here's the Reuters story