Wednesday, May 15, 2013

FDA's 'Directorates' ??? for Globalization, Deputy Commissioner Invisible Ex-J&J Exec Brenner-Gati Disappears: House Energy & Commerce Committee Investigating

Fierce Biotech has;
Suspicious lawmakers query FDA's Hamburg on sudden departure of deputy commish - 
May 14, 2013 | By 
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

Related Articles:
FDA's Hamburg touts rising approval record and promises swifter interaction
Commish says FDA needs to oversee compounders but spars with House over how

Here's the Energy & Commerce Committee Letter to FDA's Hamburg:

Here we have, from Regulatory Focus, more detail:
Posted: 22 January 2013

. . . ."As part of that change, many of the agency's centers, super-offices and offices were organized under what Hamburg called "directorates. Of the four offices created, two—the Office of Medical Products and Tobacco (OMPT) and the Office of Global Regulatory Operations and Policy (OGROP)—remain central to the oversight of healthcare product regulations.

The former office was Spielberg's, and it oversees the Centers for Devices and Radiological Health (CDRH), Drug Evaluation and Research (CDER), Biologics Evaluation and Research (CBER) as well as the relatively new Center for Tobacco Products (CTP). Veterinary foods and medicines are overseen by a separate directorate, the Office of Foods and Veterinary Medicines." . . .

. . . Stepping in to fill the void will be Leona Brenner-Gati, MD, currently associate commissioner at the agency and another long-time employee of industry before joining FDA. Brenner-Gati worked for Johnson & Johnson for 17 years in a number of senior positions, as well as Sandoz Pharmaceuticals, FDA said in its statement." . . .
The Party Central Committee "Directorates" of Global Regulation, and a seemingly Invisible Ex-J&J Executive, . . . .

This is going to be one to watch if it doesn't get buried beneath the IRS singling out Political Opponents of the Regime

the DOJ snatching Associated Press phone logs

and God only knows what else will surface before Friday on our Glorious way to the Glorious World of Next Tuesday.

And see Real Clear Politics for:

Obama to Grads: Reject Voices That Warn About Government Tyranny

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