House panel questions resignation of top FDA official

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(Reuters) – A House of Representatives panel is investigating the circumstances surrounding the resignation from the Food and Drug Administration of its acting deputy commissioner for medical products and tobacco.

In a letter to FDA Commissioner Margaret Hamburg on Monday, Republicans on the Energy and Commerce Committee demanded more information about the role played at the agency by Dr Leona Brenner-Gati, a former Johnson & Johnson executive, who resigned from the FDA on May 3.

Between February 2013 and April 2013, the FDA’s public calendar listed Brenner-Gati as acting deputy commissioner for medical products and tobacco, with no significant meetings, the letter noted. Yet an organizational chart from March 4 listed the position as vacant.

Brenner-Gati continued to be listed on the FDA’s public calendar into April 2013, and the FDA Web page for the Office of Medical Products and Tobacco, last updated on March 22, listed her as the acting deputy commissioner.

The discrepancies “raise questions about whether she was actively working in her position over the last two months, and the circumstances surrounding her resignation,” the letter said.

An FDA spokeswoman, Erica Jefferson, declined to comment on the letter.

Brenner-Gati joined the FDA in September 2012 as associate commissioner of medical products and tobacco, according to an internal memo from Hamburg on May 3 announcing her departure. She took over as acting deputy commissioner in January.

“Dr. Brenner-Gati has played a key leadership role in many critical ongoing initiatives,” Hamburg wrote.

Public records list Brenner-Gati’s residence as Princeton Junction, New Jersey, close to Johnson & Johnson’s headquarters in New Brunswick. A message left on her answering-machine at that home was not returned. It was not immediately clear where she lived while working at the FDA, which is based in Silver Spring, Maryland.

“Several days before her resignation, Committee staff could not locate Dr. Brenner-Gati on the online HHS employee directory,” the letter said, referring to the Department of Health and Human Services, of which the FDA is a part. It added that she was not featured on the FDA’s leadership profiles.

According to a profile published on the website of the Alliance for Regenerative Medicine, a non-profit organization which she helped found, Brenner-Gati previously held a variety of senior positions in science and technology at Johnson & Johnson and had a special interest in diabetes and endocrinology.

At the company, according to the Alliance, she identified a new technology involving cell therapy in diabetes, which led to the formation of BetaLogics, a Johnson & Johnson venture. Brenner-Gati served on its board.

Energy and Commerce Committee chairman Fred Upton, a Michigan Republican, and leaders of its oversight and investigations subcommittee, asked Hamburg to explain whether Brenner-Gati was placed on administrative leave, and if so, to explain when and why and indicate whether she was paid during the leave.

They also asked Hamburg to describe Brenner-Gati’s responsibilities and accomplishments since she became acting deputy commissioner, and they asked for all documents related to her financial disclosures. They also asked for all documents from FDA ethics officials related to Brenner-Gati, and all documents related to her hiring for positions at the FDA.

In her May 3 memo, Hamburg told employees that Brenner-Gati had brought “invaluable experience with innovation in science, technology, medicine and healthcare- excellent leadership and management expertise- and personal attributes, including her collaborative spirit, drive, and interpersonal skills, that will be sorely missed.”

Brenner-Gati earned a B.A. in biology from Princeton University and a medical degree from Harvard Medical School.

(Editing by Mohammad Zargham)

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