Why Did Senior FDA Official Leave Agency – Congressional Probe

Why Did Senior FDA Official Leave Agency – Congressional Probe

May 14th, 2013 // 3:27 pm @

Latest FDA and cGMP Compliance News

In May, a top ranking FDA official left the agency – Leone Brenner-Gati for ‘personal reasons.’ She left FDA only seven months after coming on board, after she had a long career at J&J. Now there is a Congressional committee looking into just what she was doing at FDA.

The House Commerce and Energy Committee is trying to understand what her role and activities were at the agency because there are some discrepancies on the organizational chart at FDA and a serious lack of meetings that she participated in. She was named Acting Deputy Commissioner for Medical Products and Tobacco in February.

For example, from Feb. to April, FDA’s calendar showed her in her latest role, but the organizational chart showed that job as vacant. Such discrepancies raise speculation if she was really working in her job in the last 2 months. They asked the FDA commissioner if Brenner-Gati had been place on admin leave at any point and if she had received pay. Congress also wants a detailed list of both her responsibilities and accomplishments.

This departure is a setback for the FDA Commissioner Margaret Hamburg. She created the Office of Medical Products and Tobacco in 2011. This office oversees both CDER and CBER. Also, Brenner-Gati quit only a week after Deputy FDA Commissioner Deborah Autor left to work for Mylan Labs.

 


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