FDA official resigns to protest Plan B decision

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--- Zuckerman <dz@...> wrote:

From: " Zuckerman " <dz@...>

<ifriends@...>

Subject: FDA official resigns to protest Plan B

decision

Date: Thu, 1 Sep 2005 23:04:25 -0400

A friend and colleague, Dr Wood resigned from

the FDA to protest their nonscientific decision to NOT

approve Plan Be (emergency contraception) for

nonprescription use. This is a big loss for those of

us who care about women's health, but it is a symptom

of the bigger problem -- FDA has become a political

arm of the Administration, rather than a scientific

one. We were quoted in today's Boston Globe on the

topic. Dr. Wood's letter of resignation, and a

statement that we issued jointly with several other

women's health organizations are all below.

Zuckerman, Ph.D.

President National Research Center for Women &

Families

1701 K Street, NW, Suite 700

Washington, DC 20006

(202) 223-4000

www.center4research.org

FDA official quits over pill delay Wood blames

politics for refusal to approve morning-after drug

By Diedtra ,

Globe Staff | September 1, 2005 WASHINGTON --

A senior Food and Drug Administration official

resigned yesterday to protest the agency's refusal to

allow over-the-counter sales of emergency

contraception. F. Wood, director of the FDA's

Office of Women's Health, detailed her decision in an

e-mail to co-workers that was quickly distributed by

Reproductive Health Technologies Project, a Washington

group that lobbies for access to contraception.

Wood, in an interview, said the FDA's credibility was

at stake since it has twice overruled staff's

recommendation to permit the morning-after pill Plan B

to be purchased without a prescription. She said those

decisions will undermine women's health.

Last summer, the FDA overruled agency reviewers and

federal advisers in denying Barr Laboratories'

application to sell Plan B over the counter without

age restrictions. In July, Barr tweaked its

application, targeting over-the-counter sales to women

16 and older. Late Friday, FDA commissioner Lester

Crawford said the agency would indefinitely delay its

decision. FDA scientists determined women 17 and older

could use the pill safely without a doctor's guidance,

but the agency is unclear about how to enforce the age

restriction.

''I'm not one to seek out this attention. The decision

[to resign] was symbolic, " Wood said. ''We've really

let FDA down, and we've let the public down if we let

this kind of decision move forward unchallenged. " The

FDA had been slated to decide whether to allow the

sale of Plan B by Jan. 21, the eve of the anniversary

of the Supreme Court's Roe v. Wade decision that

legalized abortion. But the prospect of young girls

purchasing pills without a prescription has become a

moral and political land mine for regulators.

''This is talked about as a delay but, in reality,

it's a denial for all women, " Wood said. She said

Crawford's pronouncement on Friday was so closely

guarded that most FDA staffers -- including herself --

did not learn of it until that afternoon.

Politics has trumped science in other FDA decisions,

Wood said, but two years of maneuvering on Plan B has

taken it to ''a new height. " Crawford's disclosure is

''not based on the science and it's not based on the

reality that use of this product prevents abortion if

you can prevent an unintended pregnancy, " she said.

The FDA, in a press release, called Wood's resignation

''unfortunate " and described the agency as ''committed

to protecting and advancing women's health. "

The morning-after pill packs the potency of a high

dose of regular birth control. It is most effective

when taken shortly after unprotected sex. FDA

scientists concluded the pills, already used by more

than 2.4 million American women, are safe. Federal

advisers overwhelmingly agreed, and in December 2003

they backed over-the-counter sales with no age

limitations.

Seven states already permit women to buy the pills

directly from certain pharmacies where pharmacists

write the prescriptions. Massachusetts is poised to

become the eighth state to permit such purchases if

legislators override Governor Mitt Romney's veto of

legislation allowing the sales.

Some observers say Wood's departure is especially

significant because she championed women's health

issues inside and outside the FDA. It also fuels

ongoing criticism that the agency ignored science in

its handling of Plan B.

''I can no longer serve as staff when scientific and

clinical evidence, fully evaluated and recommended for

approval by the professional staff here, has been

overruled, " Wood wrote in her e-mail, echoing qualms

expressed by Dr. K. , director of the

FDA's Office of New Drugs, when FDA leaders overruled

staff last summer.

''The FDA and the American people lost a strong voice

for scientific integrity, " said US senators Patty

Murray, Democrat of Washington, and Hillary Rodham

Clinton, Democrat of New York, in a press release.

''It is deeply disturbing that an agency long

recognized for making decisions based on sound science

has become so politicized that one of its most widely

respected, long-serving veterans would feel

disillusioned enough to quit in protest. "

Murray and Clinton are seeking a congressional hearing

on the FDA's handling of Plan B, but the Senate

Health, Education, Labor and Pensions Committee has

not set a date.

US Senator M. Kennedy, Democrat of

Massachusetts, called Wood's esignation ''courageous "

and criticized the FDA's delays as ''indefensible. "

A women's health advocate who has known Wood since the

1990s said her departure amounts to a vote of

no-confidence in the FDA. ''Losing somebody like that

is a big deal, " said Zuckerman, president of the

National Research Center for Women and Families. ''It

shows such a lack of confidence in the agency. If she

thought she could do good there, she would have

stayed. "

Wood, a former research scientist at s Hopkins

University School of Medicine's department of

neuroscience, worked for the Congressional Caucus for

Women's Issues from 1990 to 1995.

After helping to develop women's health policy at the

US Department of Health and Human Services, she became

FDA's director of the Office of Women's Health in

November 2000.

Among other issues, Wood highlighted the public health

implications of pregnant women metabolizing drugs

differently than women who typically test drugs in

clinical trials.

While she ended her resignation letter with the hope

of working with FDA ''in a different capacity, " for

now, Wood is unemployed.

''You close these sort of things with 'and I'll be

doing x and y.' Well, I don't have that x and y yet, "

she said. ''I don't have a soft landing plan. "

Diedtra can be reached at

dhenderson@....

From: Wood, F [mailto:.Wood@...]

Sent: Wednesday, August 31, 2005 11:23 AM

OC OWH; Galson, ; Goodman, ; Schultz,

; Casciano, Dan; Kweder, L; Uhl,

Kathleen; Kennedy, Dianne L; Houn, Florence; Shames,

A; Monroe, ; , ; Stockbridge,

Norman L; Toigo, Theresa A; Haffner, E;

Alderson, Norris; Brackett, ; Tollefson,

R; Bull, Jonca; Temple, ; Yetter, ; Lepay,

; Spence, ; McGarey, ; Plaisier,

Melinda K; Lumpkin, Murray; , Margaret

Subject: Notice of Resignation

Dear Friends and Colleagues,

I regret to tell you that I am leaving the FDA, and

will no longer be serving as the Assistant

Commissioner for Women's Health and Director of the

FDA Office of Women's Health.

The recent decision announced by the Commissioner

about emergency contraception, which continues to

limit women's access to a product that would reduce

unintended pregnancies and reduce abortions is

contrary to my core commitment to improving and

advancing women's health. I have spent the last 15

years working to ensure that science informs good

health policy decisions. I can no longer serve as

staff when scientific and clinical evidence, fully

evaluated and recommended for approval by the

professional staff here, has been overuled. I

therefore have submitted my resignation effective

today.

I will greatly miss working with such an outstanding

group of scientists, clinicians and support staff.

FDA's staff is of the highest caliber and it has been

a priviledge to work with you all. I hope to have

future opportunities to work with you in a different

capacity.

Sincerely, F. Wood, PhD

Assistant Commissioner for Women's Health

Director, Office of Women's Health

Food and Drug Administration

Leaders of the Women's Health Community Commend Dr.

F. Wood for her Commitment to Promoting Women's

Health and the Integrity of Science

For Immediate Release:

August 31, 2005

Washington, DC -

The national effort to improve the health of women

suffered a serious blow today with the resignation of

Dr. F. Wood as the director of the FDA's Office

of Women's Health. Dr. Wood resigned in protest over

the agency's handling of Plan B. She announced her

resignation earlier today.

The women's health community applauds Dr. Wood for her

personal commitment to the FDA's mission of making

science-based decisions to improve the health of the

public and we are very sorry to lose her. Dr. Wood was

one of the champions of a decade-long effort to

improve women's health through increased federal

research and support.

Dr. Wood's impact on women's health was felt in many

ways during her nearly 5 years at the FDA. She led the

agency's effort to ensure that women were included in

trials of new drugs and medical devices, and put into

place reporting and recordkeeping systems that enabled

researchers to quickly determine whether women were

affected differently than men by specific products.

Dr. Wood was also a key player in the FDA's efforts to

increase our shared knowledge about the effects of

medications used in pregnancy on the health of the

fetus and the pregnant woman.

Dr. Wood also demonstrated her leadership in women's

health by creating new programs to communicate

important health information to average women, such as

the FDA's Take Time to Care campaign. She was awarded

the Commissioner's Certificate of Excellence for her

work on the agency's education campaign on menopause

hormone therapy.

Dr. Wood encouraged dialogue with the FDA on a broad

range of women's health issues, from many avenues. She

welcomed input from consumers as well as industry,

health professionals and biomedical researchers.

The resignation of Dr Wood is just one example of the

damaging implications of the FDA's willingness to

ignore clear scientific evidence and clear scientific

shortcomings in their approval decisions for

prescription drugs, medical devices, and other medical

products. American women will be harmed directly by

FDA's inappropriate decisions, as well as indirectly

harmed when outstanding public servants decide to

resign from this ailing agency.

Contacts: Lorraine Cole, President Black Women's

Health Imperative (202) 543-9311

Barbara Brenner, Executive Director Breast Cancer

Action (415) 243-9301

Pearson, Executive Director National Women's

Health Network (202) 347-1140

Judy Norsigian, Executive Director Our Bodies,

Ourselves (617) 233-0062

Zuckerman, President National Research Center

for Women & Families (202) 223-4000