Re: No Timetable To Nominate New FDA Commissioner

[Guest guest]

At risk of being political, there will be no consumer health-oriented FDA until

the

government changes. The FDA is now nothing more than a corporate arm.

> 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).

> >

> http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=32778

> >

> >

> >

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> > View entire Policy Report.

> >

> >

> > 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 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.

> >

> >

> >

> >

> >