May 13 A U.S. 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
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
"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
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
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)