| Ilena Rose 2005-09-30, 1:15 pm |
| EXCERPT: According to Diana Zuckerman, president of the National
Research Center for Women and Families, von Eschenbach "is talking
about getting drugs to terminally ill patients faster, and that's a
laudable goal. But you can't approve a drug and assume it will only be
used for terminally ill patients. Everything he has been quoted as
saying suggests he doesn't understand how FDA works" (Los Angeles
Times, 9/27).
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Daily Health Policy Report
Administration News | No Timetable To Nominate New FDA Commissioner,
HHS Secretary Leavitt Says
[Sep 27, 2005]
HHS Secretary Mike Leavitt on Monday said that "there is no
timetable" for the nomination of a permanent FDA commissioner after
Lester Crawford resigned on Friday, CQ HealthBeat reports (CQ
HealthBeat, 9/27). Crawford resigned two months after his confirmation
as FDA commissioner in July. In an e-mail to FDA employees, Crawford
wrote that "after three and a half years as deputy commissioner,
acting commissioner and, finally, as commissioner, it is time, at the
age of 67, to step aside." In a letter to President Bush on Friday,
Crawford said that his resignation was "effective immediately."
Crawford, a veterinarian and a food safety expert, became FDA deputy
commissioner in 2002 and later became acting agency commissioner. Bush
named Andrew von Eschenbach, director of the National Cancer
Institute, as acting FDA commissioner (Kaiser Daily Health Policy
Report, 9/26). Von Eschenbach on Monday in an e-mail to cancer
research advocates called his appointment "an interim role" and said
that he will "work to ensure an orderly transition of a new, permanent
commissioner at the FDA" (Alonso-Zaldivar, Los Angeles Times, 9/27).
However, CQ HealthBeat reports that "von Eschenbach may be running the
agency on an acting basis for a considerable time." According to an
unnamed Washington, D.C., consultant, "The candidate pool has weakened
considerably," and an "abortion litmus test" has eliminated some
"strong" candidates who support abortion rights (CQ HealthBeat, 9/26).
Von Eschenbach said that he will continue to serve as NCI director
during his tenure as acting FDA commissioner, adding that he hopes to
"closely integrate the discovery aspects of biomedical research" with
the FDA approval process to provide patients with "the full benefits
of molecular medicine"
Ability To Head Two Agencies Questioned
In a letter to White House Chief of Staff Andrew Card on Friday,
Senate Finance Committee Chair Chuck Grassley (R-Iowa) wrote that Bush
should not name von Eschenbach as acting FDA commissioner because an
individual who heads both FDA and NCI will not have the ability to
"dedicate 100% of his or her time and talent to the nation's public
health and safety agency." Grassley said, "It's not possible to give
the FDA the kind of strong leadership that is needed to reinvigorate
the agency on a part-time basis" (Pear, New York Times, 9/27). New
England Journal of Medicine Editor in Chief Jeffrey Drazen said,
"These are agencies with big budgets that make a lot of decisions that
influence the health of individual Americans. What we really need are
two highly qualified, motivated individual leaders" (Los Angeles
Times, 9/27). However, Billy Tauzin, president and CEO of the
Pharmaceutical Research and Manufacturers of America, said that the
leadership of von Eschenbach and the "expertise of dedicated veteran
FDA regulators will allow the agency to continue its important work
until a new commissioner is nominated and confirmed" (Higgins,
Washington Times, 9/27). In a research note, Prudential Securities
analyst Diane Duston said that von Eschenbach could face difficulties
as head of both FDA and NCI, adding that the Bush administration might
have to name an acting NCI director (Heavey, Reuters News, 9/26).
Conflict-of-Interest Concerns
Some critics questioned whether von Eschenbach has a conflict of
interest as the head of both FDA and NCI. Curt Furberg, a professor at
Wake Forest university and an FDA adviser, said, "It is very hard for
him to be in both positions and deal with requests regarding cancer
drugs. I really see a potential conflict. As head of NCI, he may be
very eager to get drugs approved by FDA, particularly drugs that have
been developed and tested by NCI" (Los Angeles Times, 9/27). Citigroup
health care analyst Paul Heldman said that von Eschenbach "appears to
be industry friendly, particularly in the oncology area," adding that
von Eschenbach "transformed [NCI] from a research center to one that
generates cancer treatments and strategies for prevention" (CQ
HealthBeat, 9/26). According to Diana Zuckerman, president of the
National Research Center for Women and Families, von Eschenbach "is
talking about getting drugs to terminally ill patients faster, and
that's a laudable goal. But you can't approve a drug and assume it
will only be used for terminally ill patients. Everything he has been
quoted as saying suggests he doesn't understand how FDA works" (Los
Angeles Times, 9/27). Michael Jacobson, executive director of the
Center for Science in the Public Interest, said, "The FDA does not
need someone who will choose speed over safety, or else we'll have a
lot more Vioxx" cases (Washington Times, 9/27).
Editorials
Several newspapers recently published editorials that addressed the
resignation of Crawford and the appointment of von Eschenbach as
acting FDA commissioner. Summaries appear below.
Long Island Newsday: The "troubled FDA needs a permanent, full-time
commissioner who will ensure that decisions about the safety and
effectiveness of drugs ... will be based on credible science,
uncolored by political agendas," according to a Newsday editorial. The
editorial states, "Re-establishing its tarnished credibility has to be
among the agency's top priorities now," as FDA "is too important to
let reasonable doubts about its objectivity and capabilities continue
to fester" (Long Island Newsday, 9/27).
New York Times: The "stopgap solution" to the "surprise resignation"
of Crawford -- the appointment of von Eschenbach, the NCI director, as
acting FDA commissioner -- "can only weaken both agencies," a New York
Times editorial states. According to the editorial, FDA, "with
regulatory jurisdiction over huge swaths of the economy, surely needs
a full-time steward," as the "interim appointment could stretch out
for some time." In addition, von Eschenbach "emphasizes ... a stance
that could lead to looser regulation," although "FDA's recent problems
suggest a need to monitor drugs more closely," the editorial concludes
(New York Times, 9/27).
Wall Street Journal: The "problem" with FDA "has been largely one of
inattention and failure to modernize, not reckless drug approvals or
cozy relationships with Big Pharma," according to a Journal editorial.
The appointment of von Eschenbach as acting FDA commissioner is an
"encouraging sign that the administration may finally be taking the
FDA seriously" because he "understands that the FDA's job isn't merely
to police the pharmaceutical companies but also to speed good
therapies to patients," the editorial states (Wall Street Journal,
9/27).
Broadcast Coverage
WAMU's "The Diane Rehm Show," an NPR-syndicated program, on Tuesday in
the first hour is scheduled to include a discussion of the future of
FDA after the Crawford resignation. Guests on the program are
scheduled to include John Calfee, resident scholar at the American
Enterprise Institute; David Kessler, former FDA commissioner; Julie
Rovner, NPR health policy correspondent; and Susan Wood, former
assistant commissioner of the Office of Women's Health at FDA (Rehm,
"The Diane Rehm Show," WAMU, 9/27).
The complete segment will be available online in RealPlayer and
Windows Media after the broadcast.
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