No Timetable To Nominate New FDA Commissioner

[Guest guest]

Thanks Ilena,

>

> EXCERPT: According to 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

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> 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 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

> 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

> 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,

> 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 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

> 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).

> son, 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.

>

>

>

> a.. 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).

>

>

> b.. 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).

>

>

> c.. 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 Calfee,

> resident scholar at the American Enterprise

> Institute; Kessler, former FDA commissioner;

> Rovner, NPR health policy correspondent; and

> 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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