Regulatory Focus™ > News Articles > Legislators Launch Investigation into Resignation of Prominent FDA Official

Legislators Launch Investigation into Resignation of Prominent FDA Official

Posted 14 May 2013 | By Alexander Gaffney, RAC

Republican legislators on the House Energy and Commerce Committee announced on 13 May 2013 that they are opening an investigation into the unusual and unexpected departure of one of the US Food and Drug Administration's (FDA) top-ranking officials, Leona Brenner-Gati, who resigned last month citing "unexpected personal circumstances."

Background

Brenner-Gati served as deputy commissioner of FDA's Office of Medical Products and Tobacco (OMPT), an office only created in July 2011 under the initial leadership of then-deputy commissioner Stephen Spielberg. The office contains most of FDA's healthcare product regulatory centers, including the Center for Drug Evaluation and Research (CDER), the Center for Devices and Radiological Health CDRH) and the Center for Biologics Evaluation and Research (CBER).

On 3 May 2013, Hamburg sent a letter to the entire FDA announcing that Brenner-Gati had departed from the agency that very day-an extremely unusual development given Brenner-Gati's status as deputy commissioner and the fact that she had only assumed her duties in February 2013, just two months prior.

Contrast the announcement with another one released that week, that of Deborah Autor, deputy commissioner for the Office of Global Regulatory Operations and Policy (GO). After an 11-year career with FDA, she, too, announced that she would be leaving the agency. The difference: Autor isn't leaving until 1 June 2013, giving FDA approximately a month to search for a replacement for her. As of the time of Brenner-Gati's departure, the agency did not have any named replacement for her on either an acting or permanent basis.

Hamburg's email went on to note that Brenner-Gati-who came to FDA from Johnson & Johnson-had "played a key leadership role in many critical ongoing initiatives," and asked staff to "join me in thanking Dr. Brenner-Gati for her contributions to FDA and in wishing her all the best in her future endeavors."

Contradictions and Questions

But in a letter to Hamburg released on 13 May 2013, House Republicans expressed both confusion and skepticism regarding Hamburg's explanation of Brenner-Gati's departure.

Among the most troubling aspects to them was the lack of any "significant meetings" held by Brenner-Gati during the two months she served as deputy commissioner of OMPT. Such meetings are generally released to the public on FDA's website and explain who the commissioner and other top staff are meeting with and why. Legislators pointed to several apparently contradictory documents, some of which showed Brenner-Gati serving as deputy commissioner, while others did not.

In another instance, legislators said their staff was unable to find Brenner-Gati's contact information in FDA's employee directory or anywhere else on FDA's website.

"The discrepancies in FDA public information about the status of Dr. Brenner-Gati, and the lack of significant meetings held since she was appointed Acting Deputy Commissioner for OMPT, raise questions about whether she was actively working in her position over the last two months, and the circumstances surrounding her resignation," legislators wrote.

To that end, the legislators said they had wanted answers from FDA regarding whether Brenner-Gati was placed on administrative leave, what her responsibilities and accomplishments were during her tenure, and whether she had any ethics investigations open at the time of her resignation.

The letter was signed by Energy and Commerce Committee Chairman Fred Upton, Oversight and Investigations Chairman Tim Murphy and Oversight and Investigations Vice Chairman Michael Burgess.


Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe