CREW: Food and Drug Administration - Plan B: OL1

~tnited oStates
WASH1AlGTON, DC 2051 0
Joshua Sharfstein, M .D .
Acting Commissione r
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, Maryland 2090 3
Dear Dr . Sharfstein :
We write with conce rn regarding the. unprecederited actions taken by the Food and Drug
Administration (FDA) to allow the morning after pill Plan B (levonorgestrel) to be sold to minor
O &
children without first receiving care from a physician `.4s you Iow, t7ies 00 initialan7
approval of over-the-counter (OTC) sales of Plan B also requiredt~fiatminor c~ildren~ under the
age of 18 obtain a physician's prescription
:__in
. order
_.. . to:_obtain
. ~ .. ..these
..~. ..~~<,-:fiig~
. dose~orniones
~ An.....~:,:._~.,.~ ..
.-. .~.~...~
April 22, 2009 statement by the FDA indicates that~I'lanB may soon eGsold T'Cto mmors as
young as 17 years of age .
We note that Plan B contains . much ..higher-_doses of hormones

_ .than .: birth.,,control _ ;. . .~ ~pills
_~ .. . contain,
... bu t
birth control pills continue to require a physician's prescription. ''A physiciari also provides
medical care with the prescription, including examination for contrairic~icahons an~monitonng -
throughout the time of use . The OTC status of Plain'S, which .wilf now fie availa6le to minor '
children, means that many womrneri may°take Plan B without the benefit ~ ~of . . tlie.~.. standard
>~ ~ .:of.. car e
received by women taking lower-dose birth control or the close physician couns -~, :_ ehng and . .. .
monitoring that accompanies patients' decisions to use every oiher oral, systemic~irth , .,,, . . control
nroduct . In addition to sound science, we believe that FDA decisionsmust be Qu1ded b v
common sense.
~, .~ ~ ...u:_.. ._ .:w_ ~ _ Y . .. . .~_ .__ .. :_.
We continue to have overarching policy concerns with the OTC avaitabilityofplan ~"B, inc-ludm g
the potential for Plan B 'f6 be given to women and minors in order to cover up sexual abuse In
cases of abuse, it is often a victim's interaction with a physician
.,, or other medical profession-a7
__~ :. . ~._~ ~ . ..... Y. _ _ a,: .. . . .< : ,. .
that detects and then prevents furtherabuse : We `are concern' : , e~ tli
.w ..,. .:.~ _ :at
. -te removaothe
.~, . ., .- ..... .., ... ., sa.~eguaxd
~ ._. . : ~__. . ., ... . , _ .. . _ _~_ . . .. . .
of a physician's examination and prescription before 1?lan~ can be obta~nec~~ result m senou s .
. . :_'.. . . :. . A.
. . .
~e. .s .M :. .-r..~ ; :. . .Y .«. u :
unintended consequences . This is particularly froubling` wlien fiDA has move to aClow the OT~ `µ "
sale of Plan B to minors .
We hope to better understand the government's decision not to appeal the March 23 ; 2009
federal court decision, which ordered the FT-A to reverse its restrictionson-OTM-ale o~Pian~' ~
to 17-year olds . Please provide detailed 'answers to t~e followinjZ auestions ari reciuests forX` --` - _
information :
• In August . of 2006, both the FDA Acting Commissioner and the Director of the Center for
Drug Evaluation and Research (C DER) found that restrictin g OTC sales, of Plan B to
women age 18 and older was appropriate . The FDA Acting Commissioner_wmte . then _
that "18 (rather than 17) is the more . appropriate cutoff point to best promote and protect
the public health ." Other than the court's findings, has the FDA received any new
scientific evidence that granting 17-year old minors unfettered 4TC - ,. ..access
:,.~..:~ ~ .to . ..._ _ . e
high-dos
<. .~
hormones is now in the best interest of the public health? : .. . _ _
• What studies have been completed on the impacts of Plan B's, high doses of hormones on .--
women of various ages taking Plan B? Please, provide a summary analysis of the studie
_s , .
on the biological spectrum of 'impac t
• Please provide a detailed,analysis

.~ .~ of the label comprehension studies submitted to the
FDA in order to obtain initial OTC approval in 2006 Please ,.. . include the population size
.. .~:,~. ...~.~.
of these studies, specifically including the number_of women under the age of 18 tha t
were included in this study. Please provide a summary analysis of whether or not the
results differed in women under the age of 18 .
• Please provide a summary analysis of the impact of OTC Plan B_aoval on. help-
seeking behaviors . What process did. the FDA use to consider the potential impact that
OTC availability of Plan B_might have on help-seeking behavior, i ncluding the potential
for patients to lose the opporEunity to receive counseling about safe sexual practices and
the consequences this might have? What conclusions did the FDA reach, and more
specifi cally, does the Agency believe that OTC_ availability
.,. ,....: of Plan
different impact on the help-seeking behavior of adult women versus girls under the age
of 18 or does FDA believe that the practices of both these age cohorts, and their ,
propensity to seek counseling, are analogous? What data did FDA rely on to inform its
views of the impact that OTC availability would have on help-seeking behavior for
woman under the„age of 18? Piease provide details on the manner in which this data was
collected, including the actual process used_to provide this product to girls under the age
of 18 and to collect information about how used the product.
• Please provide a summary analysis of any adverse events,reported from the use of Plan B
since its initial Rx approval and since its limited OTC, a,pproval .
• In August of 2006, the Director of CDER concluded

~_.~ . that "the
~ CARE ..program
. .. [was]
sufficiently rigorous to prevent young women from obtaining Plan B[OTCj witfiouf the`
supervision of a practitioner licensed by law to prescribe, the drug ." The CDER Director
noted that "Monitoring of the program's
_, effectiveness will
. ,. . _. ..allow
. FDA to assess whether
w
further modifications will be necessary
, . to prevent inappropriate use of Plan B ." Please
provide the results and a summary analysis of the results ofthus monitoring . Has the
FDA reviewed whether or not further_ _. modificati
. -.- ons arenecessary
= to preven t
inappropriate use?
• In order to obtain FDA approval in August of 2006, Barr Pharmaceuticals agreed to the .
following activities : 1) monitor trends in the use of emergency contraception to evaluat e
the effectiveness of the CARE prograrri, 2) use relevant survey data. regularly collected by
others to monitor for potential indicators that Plan B is being usedin aninappropriate
manner, 3) conduct a"Point-of:Purchase Monitoring . Program" to track how Plan B i s~_
being sold at the time of purchase, and. 4) report
,. to FDA ontheresults of these activitie s
. .. - . :
,
on a six-month interval, .,- Please pro
a summary analysis of these reports .
• Please provide a specific list of the names and positions of each FDA staff member -----
involved in the government's decision not to appeal the March 23, 2009 federal court ,
decision, which ordered the FDA to. reverse its restrictions on OTC sale of Plan B t6-1 7-
year olds .
• Please provide a copy of any Executive Branch communications regarding the

government's decision not to appeal the federal; cou.rt decision. Specifically, please
provide a copy of any communications regarding the decision notto appeal between
officials of the Department of Justice, officials of theFDA, and/or officials at the Whit e
House .
• Please describe any interaction and provide copies of any communications regarding Plan
B between Barr Pharmaceuticals, or its subsidiaries, and either the FDA or the
Department of Justice since August of 2006 .
We also note that the court ordered the FDA toreview th~_e. appropriateness of making the
emergency contraceptive available to all ages without first seeking the care of a physician .
What are the next expected steps on the part of the FDA to . fulfill this order? As the
_ ,FD A , ._. . .
w,.
undertakes this review, we look forward to learning of any new scientific evidence that would
support a conclusion different from theconclusion reached in August 2005 . by the Center for
Drug Evaluation -and . Research (CD-ER) . CDER found then that "Barr [Pharmaceuticals] had not
established that Plan B . could be used safely and effectively by young adolescents-girls 16 and
younger-for emergency contraception without the professional supervision of a practitioner
licensed by law to administer the drug . "
Finally, we are concerned that thefailure to appeal the March 23, 2009, federal court decision,-
which supersedes the FDA's decision-making authority, establishes a new legal precedent .
While traditionally the courts have given great deference to the FDA on matters of its revie w
process, we worry that this failure to appeal will lead to the .courts second-guessing the FDA's
findings in future cases . We are concerned about the effect this may have on ensu ri ng that the
FDA's review process is based on sound science-.
Sincerely ,
Carr my.., Vyl

W ~ L~~
Stevens, Joy S
From : Susan Thaul [STHAULQcrs .loc .gov]

Sent : Thursday, August 24, 2006 7 :12 PM
To : Stevens, Joy S .
Subject : Congressional questions about Plan ' B
Joy : A Member of Congress asks that we answer the following questions I n a "time-sensitive" manner .
I've looked through today's FDA press release and the associated material (memos from Drs von Eschenbach
and Galson, the Q and A, the approval letter, and the labeling) . Those documents relate to manyof these
questions, but do not directly address the specifics : Please provide FDA's response to these questions as soon a s
possible .
Questio n
FDA approved the OTC sale of Plan B to . women aged Y8 and . older, while requiring a prescription for women
younger than 18 .
1 . What group, if any, is responsible for enforcing that distinction ?
2 . What group, if any, Is responsible for setting up procedures to-prevent sale to a woman
;. . who is less than 18
years old ?
3 . What group, if any, is responsible for determining when It does happen?
,
.
For the following questions, consider
- Federal law (FDA, FCC)? State laws (pharmacy)?
- ClimInal law? Civil law?
- What consequence/penalty?
4. What law, if any, does the pharmacist or pharmacy employee break by making that~sale ?
5 . What law, if any, would an adult woman be violating if she 'bought the 0TC drug and gave it to en underag e
woman?
6A . Could an adult male buy the OTC drug ?
6B . What law, if any, would an adult male be violating if he bought the OTC drug and .7gavel to an underage
woman ?
7 . If an Individual purchases a prescription drug (according to a valid prescription

_ : to
_ that
. . . individual),
_
what law, If any, that Individual vioiate by glving it to sorneone else ?
8A . Are there any OTC drugs that are indicated for men or women only? '
8B. If so, what law, if any, restricts sale to the Indicated sex ?
Thank you . -Susan
1'~Susan Thaul, Ph .D .
Congressional Research Servic e
Library of Congress ' -
8/25/2006
Page 2 of 2
telephone : (202) 707=0562

fax : (202) 707-3097
e-mail : sthaul@crs .loc .gov
8/25/2006
TOM DAVIS, VIRGINIA, HENRY A. WAXMAN. CALIFORNIA,
CHAIRMAN RANKING MINORITY MEMBE R
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http://reform .house.gov
August 23, 200 6
Andrew von Eschenbach

Acting Commissioner
U . S . Food and Drug Administration
5600 Fishers Lane
Rockville MD 20857-000 1
Dear Dr. von Eschenbach :
The Subcommittee on Criminal Justice, Drug Policy and Human Resources

urgently requests a complete and un-redacted copy of the most recent supplemental new
drug application (sNDA) from Duramed Research, Inc . (and/or Barr Pharmaceuticals) for
Plan B (levonorgestrel) Tablets . This request encompasses any supplemental documents
or letters submitted by, or on behalf of, DuramedlBarr since its most recent sNDA .
Please fax or deliver a copy of the sNDA as soon as possible, but no later than
4 :30pm today, to the Subcommittee's office in B-377 Rayburn House Office Building
(fax : 202-225-1154) .
Sincerely,
Mft E . Souder
Chairman
Subcommittee on Criminal Justice ,
Drug Policy and Human Resources
Government Reform Committee
Apr 08 2000 12 :25PM HP LRSERJET FAX
AUG-11-2006 11 :54 From :SENATE 202
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August 10, 2006
Dr. Andrew C . von Pschonbach

Acting Commissioner
U .S . Food and Drug Administration
Parklsv,rrt Buildin g
5600 Fishers Lane
Rockville, MD 2085 7
Dcar Dr. von Eschcnbaah :
I un disheartened by recent reports about the steps FDA is taking to grant Plan B over-
the-counter status for women age eighteen and older . I believe it is very important that
women and young girls talk to a doctor before taking such a powerful drug . They need to
be well-informed on exactly how the drug works and its impact on a woman's body ,
This would also allow the doctor to review the woman's-m.edical health to make sure
there are no contra-indications for taking this drug. Lower doses of thts drug require a
doctor's prescription. It seems to be common sense that the higher dose found in Plan B
should also only be available after being seen by a doctor.
In addition, although I appreciate that the discussed agreement would require individuals
to talk to a pharmacist and show photo identiftcation to establish age hef,ore receiving the
drug, there appcars to be no way to prevent those over age eighteen from obtaining Plan
B and giving it to others of any age. Again, this would be without the supervision o f a
doctor . Indeed, as I understand it, there would appear to bona restrictions ontlie 1111710-tint
that can be sold to one individual to prevent that person from abusing the drug or giving
it to others so that not even a pharmacist is involved in an individual taking such a drug,
It is imperative that the FDA take these concerns scriodsly, i would specifically like to
know what steps FDA and the manufacturer of the drug will be taking to ensure that girls
under the age of eighteen will not have access to the drug should ovcr-the-counter status
be approved . I look forward to your response on this important issue ,
Rick Sairtorurn
United States Senate
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DISTRICT OFRCE :
WALTER B . JONE S 11 O5--C CORPORATE DRIVE
3D DIBTRICT, NORTH CAROLIN A GREENVILLE, NC 27858
(252) 931-100 3
. Room 422 (800)351-169 7
CANNON HOUSE OFRCE BUILDING
WASHINGTON, DC 205 1 5
TELEPHONE : (202)225-341 5
Con grea of the an iteb ~itateg
COMMtTTEES :
COMMITTEE ON ARMED SERVICES
30 Dtlge._Df R Qpregelltatibtg
COMMITTEE ON FINANCIAL SERVICES ~irigtott, ~~ 20515-3303 _
COMMITTEE ON RESOURCES
August 3, 2006
Andrew C. von Eschenbach, M .D .

Acting Commissioner
U .S . Food and Drug Administration
5600 Fisher's Lane
____ . . .
Rockville, Maryland 20857-0001
Dear Commissioner von Eschenbach :
It has come to my attention that the Foodand ;Drug Administration ("FDA") may
_. ..~~.Plan
be willing to allow over the counter •_access to the . .~B Morning After Pill to . women
over 18 . While the timing of this surprise decision appears to be questionable, I would
urge you to not allow this dangerous and unnecessary practice .
Many harmful effects may come from the use of Plan B without, . a prescription .
Currently, the FDA requires a prescription for oral contraceptives that are taken . daily .
These contraceptives have doses of liormonesthatare much_ower an those contained
in emergency contraceptives . In fact, one dosage of emergency contraception is
equivalent to twenty doses of regular oral contraceptive . By taking Plan B, a woman will
have consumed more than a month's worth of contraceptives in less than a w e, ,
Also, by allowing women to use Plan B . without a prescription and physician

supervision, the risk for dangerous side effects will increase . Plan B -'has shown side . .
effects of ectopic pregnancies, significant weight gain, depression, gallbladder disease,
high blood pressure, and respiratory disorders . In countries where Plan B is available
without a prescription, there have been increased . rates of sexually transmitted diseases .
~~.
Plan B is a potentially dangerous drug and I urge you to consider the harm ful
effects it could cause if accessible over the counter. . It is imperative that Plan B iiot be
accessed without a proper prescription and physician supervision and I encourage you to
come to the same conclusion . I look forward-to heanng from you on this important
matter .
Walter B . lJones
Member of Congress
;_ 0 D (~ - (a q 33
DEPARTMENT OF HEALTH & HUMAN SERVICES

Rockville MD 2085 7
JA N 3 1 2007
the Honorable Walter B . Jones
House of Representatives
Washington, D .C . 20515-3303
Dear Mr. Jones :
Thank you for the letter of August 3, 2006, regarding the Food and Drug Administration's
(FDA) review of a then-pending supplemental new drug application to make Plan B, a
contraceptive drug product, available as an over-the-counter (OTC) option for women aged 18
and older. Plan B is often referred to as emergency contraception or_ the "`morning
m after _ . . . . . ",.
..pill
As you may know, on August 24, 2006, FDA approved PlariB for O'f~ use;for women .ages -
18 and older, while the product remains available by prescription-only for women ages 17 and
under .
As you noted in your letter, Plan-B contains an ingredient

. used.. . in
. prescription birth control
pills--only in the case of Plan B, each pill contains a higher dos . e and the product has a
different dosing regimen . Like other birth control pills, Plan B had previously been available
to all women as a prescription drug .
You explain your concerns about the availability of Plan B OTC, including taking a large
dose of a hormonal contraceptive at once without a practitioner's involvement . You
specifically state that "Plan B has shown side effects of ectopic
. pregnancies, significan t
weight gain, depression, gall bladder disease, high blood pressure, and respiratory disorders ."
These, however, are not known side effects of the drug . Rather, FDA-approved labeling lists
nausea, tiredness, menstrual changes, vomiting, diarrhea, breast pain, stomach pain, dizziness,
and headache as the known side effects . FDA has determined that when used as directed,
Plan B effectively and safely prevents pregnancy, and that the product is safe and effective for
use OTC for women ages 18 and older . FDA based this decision on data received from the
drug's sponsor supporting OTC use.
In addi ti on, the sponsor, Duramed, a subsidiary of Barr Pharmaceuticals, has made Plan B
available with a ri gorous labeling, packaging, education, dist
_ ribution, and monitoring -
program. In the CARE ( Convenient Access, Responsible Education) program, Duramed
committ ed to :
• Provide consumers and health care professionals with labeling and education about the
appropri ate use of prescription and OTC Plan B, including an informational toll-free
number for questions about Pl an B ;
*S
Page 2 - The Honorable Walter B . Jones
• Ensure that distribution of Plan B will only be through licensed drug wholesalers, retai l
operations with pharmacy services, and clinics with licensed health care practitioners ,
an d not through convenience stores or other retail outlets where it could
.. be made
available to younger women without a prescription ;
• Packaging designed to hold both OTC and prescription Plan B . Plan B_will be stocked
by pharmacies behind the counter .because
_it. , cannot be dispensed without a prescription
; and to monitor the effectiveness
_orpfage of the age restriction and the safe -
distribution of OTC Plan B to consumers 18 and above and presc ription Plan B to
women under 18 .
FDA's approval of the Plan-i3 OTC for consumers ages 18 and older concludes an extensive. _
process that included obtaining expert advice froma joint meeting of two FDA advisory
committees and providing an opportunity for public comment on issues regarding the
scientific and policy questions associated with the application to switch plan B to OTC use .__
The Agency remains committed to a careful and rigorous scientific process for ensuring that
drug products are safe and effective for their intended uses and to its responsibility to protect
the health of all Americans .
Thank you again for contacting us concerning this matter . . If you have further questions,
please let us know .
Sincerely,
Michele Mital
Acting Deputy Assistant Commissioner
for Legislation
r
President Pro Tempore

o
c unnitteem
Ted Stevens Chairman
Commerce, Science, and Transportatio n
Alaska Washington, DC 2051 0
(202) 224-3004 Appropriations
(202) 224-2354 (Fax) Governmental Affairs
Rules and Administration
Library of Congres s
July 24, 200 6
David W . Boyer
Assistant Commissioner for Legislation
Food and Drug Administratio n
U .S . Department of Health and Human Services
15B-31 Parklawn Buildin g
5600 Fishers Lane
Rockville, Maryland 20857
Dear David :
Enclosed is a copy of a letter I received fron~~~s o .

regarding the over-the-counter availability of the morning after pill, Plan B. I would ~ .
appreciate any information your agency can provide me so that I may respond to Ms . y~l (0
Please direct any questions you may have in regard to this inquiry to Nicolia
Demopoulos on my staff. Replies to this correspondence should be sent to: P.O . Box
1766, Washington, DC 20013 . Thank you for your assistance .
With best wishes,
-TED STEVENS
Anchorage Fairbanks Juneau Wasilla Kenai Ketchikan Bethel

(907)271-5915 (907) 456-0261 (907) 586-7400 (907)376-7665 (907) 283-5808 (907) 225-6880 (907) 543-1638
From :
Sent : ursday, Jury°K 2006 3 :23 P M
To : senator-steven,s@exchange .senate .gov or
Subject : CF-MAI L
~ ~-..;....f
<IP>209 .193 .21 .76</IP >

<PREFIX>Ms .
<FIRSTNAM /FIRSTNAME>
<LASTNAME ~LASTNAME>
<ADDRESSI / ADDRESS1>
<ADDRES ADDRESS2 >
<CITY </CITY>
<STATE /STATE>
<ZIP>99603<
<HOMEPHONE~~/HOMEPHONE >
<WORKPHO
<EMAIL MAIL>
<SUBJECT>Health</SUBJECT>
<MESSAGEBODY>Dear Senator Stevens,
It is extremely important that the morning after pill be approved for over the counter
sales . Please advocate for women's rights on this issue . Do not let it become a political
issue .
Choice is a freedom we should have in this country .</MESSAGEBODY> .<AddressTo>General
</AddressTo>
1
I
4,M1+YlIQ ' Food a n d Drug Administration
Rockville MD 20857
. The Honorable Ted Stevens

United States Senate
Post Office Box 1766
NO V 8 2006
Washington, D .C: 2001 3
Dear Senator Stevens :
Thank you for the letter of July 24, 2006, on behalf of your constituent, Ms ; CX
who wrote requesting information concerning the product, Plan B . She is
inquiring w et er`this emergency contraceptive product is available in an over-the-counter
(OTC) status from a pharmacy.
On August 24, 2006, the Food and Drug Administration, (FDA or the Agency) approved an
application from Duramed, Inc ., the sponsor, to allow the sale of Plan B as an OTC product
for women 18 years of age and older . For those women 17 and younger, a prescription from
a health care provider is still required. To ensure distribution of Plan B meets requirements
as approved, it will only be provided through retail operations with pharmacy services and
clinics with licensed health care practitioners . Since the same package is used to fill
prescriptions as well as OTC requests, the product will be stocked behind the counter at a
pharmacy because it cannot be dispensed without either a prescription or proof of age .
We are enclosing a copy of the Agency's press release of August 24, 2006, on this approval as
well as a copy of the information page on FDA's website that provides access to a number of
documents related to the Plan B application . The info page can be found at :
http ://www.fda.govlcderlinfopagelPlanBldefault .htm .
Thank you for contacting us about this matter. If we can be of further assistance, please let
us know.
Sincerely,
avid W . Boyer
Assistant Commissioner
for Legislation
2 Enclosures
~07/ 13 /06 10 :18 FAX
(gIIIT g TPa ,S of t4 P UIIt tPh §tFCtPs

39ashingtnn, MC 20515
July 13, 2006
r
Dr . Andrew C . von Eschenbach
Acting Commissioner
5600 Fishers Lane
Rockville, Maryland 2085 7
Dear Dr_ von Eschenbach:
We would like to voice our opposition to the Food and Drug Adininistration's (FDA )
continued delayed decision of Barr Laboratories' application for Plan B emergency
contraception to be distributed oVer-the-counter (OTC) .
After more than two years of delay, on August 26, 2005, _ the FDA
, ._.: . . again
. postponed its
decision indefinitel y nitely to make Plan B emergency contraception available as an over-the-
counter product to help women prevent unintended pregnancy :
Even while stating that "the available scientific data are sufficient to support the safe use
of Plan B as an OTC product . . . for women who are 17 years of age or older," the FDA has
postponed making a determination . The Agency has engaged in unnecessary delays to
keep Plan B off of drug store shelves, where its accessibility will het ~ wom.en most.
Emergency contraception has been found to meet all the criteria for over,the-counter use :
low-toxicity, no potential for overdose or addiction, no teratogenncity (is not harmful to
an existing pregnancy), no need for medical screening, self-identification of the need ,
uniform dosage and no important drug interactions . We believe that in the FDA' s
continued delay in deciding on the application for EC over-tlie-counter status, science
and safety have taken a back seat to politics . ,
Access to emergency contraception decreases

. _ .__ _. , the .risk of unintended pregnancy .
Whatever one's views on abortion, we all can recognize the importance of preventing
unintended pregnancies .
Therefore, we ask you to render a decision on the status of Barr Laboratories' application
to make EC available over-the-counter without further delay. Thank you for your
attention to this important matter. We look forward to your prompt response .
Sincerely,
Louise Slaughter
Member of Congress
Diana DeGette
Member of Congress
07/13 /06 10 :18 FAX 0o02
Rick Larsen
Member of Congress
r1MlSik -Sleven Kirj/ "s Moore

Member of Confres s Member of Congress
Brad Miller
Member of Congres s
Ed Cas e
Member .of Congress
Patrick Kennedy Rush Holt

Member of Congress Member of Congres s
Mark Udall
Member of Congress
Cy J akowsky
Member of Congres s of Congress
tA lw4,
kobert Wexler
Member of Congress
/-*~ , w 0'. . --
Tom Allen
Member of Congress
~w[~'.=a.iA~+Y~rzsrRa`.:~'iOAL;~ab~ ~t• Jr!sie ~R Ms~^•.h"~ ~ _ . - . ~ ~ . . .
r. ~.~ Y. ; z. ., - .. .'.~~YfSS3#C :
"~3~Ii',=5i54' P5~}~`:f.;X ..., ..~ .~~ i r .. . . . . -
07/13/0 6 10 :18 FAX
C yn Maloney r/ Danny Davis

Member of Congress MSqiber ofZongres s
•G mef !!-!
Carson
1111a ' ` ~uVb C arn&6 Tl
Member of Congress Member of Congres s
Steve Israel
Member of Con gres s

Rockville MD 20857
SEP 15 2006
, The Honorable Christopher Shays

Dear Mr . Shays :
This is in response to your letter dated July 13, 2006, co-signed by 45 of your colleagues,
in which you asked the Food and Drug Administration (FDA) to^"render a decision on the
status of Barr Laborato ri es' application to make EC (emergency contraception)_ available
over-the-counter without fu rther delay." On August 24, 2006,FDA approved Barr's
supplemental new drug application . As a result, Plan B is approved for over-the-counter
marketing for those ages 18 and older, and remains available by prescription for women ages
17 and younger . Additional information is available on FDA's website at :
http : //www.fda.gov/cder/drugs/infopage/PlanB/default . htm
Thank you for your letter and your continued interest in this issue . If we can be of further
assistance, please let us know . A similar response is being sent to each of the other co-
signers of your letter.
Sincerely,
id W_. Boyer
for Legislation
suvurr .
s f
~ DEPARTMENT OF HEALTH & HUMAN SERVICE S
, _ __ ... . . . . _
r+
M
Rockville MD 20857
SEP 15 2 .006,
• The Honorable Louise M . Slaughter

Washington, D .C . 20515-322 8
Dear Ms . Slaughter :
in which you asked the Food and Drug Administration (FDA) to "render a decision on the
status of Barr Laboratories' application to make EC (emergency contraception) _. availabl e
over-the-counter without further delay." On August 24, 2006, .. FDA approved Barr's
supplemental new drug application . As a result, Plan B is approved for over-the-counte r
marketing for those ages 18 and older, and remains available by presc ription for women ages
http : //www.fda .gov/cder/drugs/infopage/P1anB/default . ht m
assistance, please let us know. A similar response is being sent to each of the other co-
signers of your letter .
Sincerely,
D 6id W . Boyer
for Legislation

Rockville MD 2085 7
SEP 15 200 6
• The Honorable Rob Simmons

Dear Mr. Simmons :
This is in response to your le tter dated July 13, 2006, co-signed by 45 of your colleagues,
in which you asked the Food and Drug Administration ( FDA) to "render a decision on the
status of Barr Laborato ri es' application to make EC (emergency contraception) available
over-the-counter without further delay ." On August 24, 2006, FDA approved Barr's
http ://www.fda.go v/cder/drugs/infopage/PlanB/default. htm
Sincerely,
D&vi"d W . Boyer
Assistant Commissione r
for Legislation

Rockville MD 2085 7
S EP 1 5 2006
. The Honorable Judy Biggert

. House of Representatives
Dear Ms . Biggert :
This is in response to your letter dated July 13 ; 2006, co-signed by 45 of your colleagues,
in which you asked the Food and Drug Administration (FDA) to ``render a decision on the
status of Barr Laboratories' application to make EC (emergency contraception) available
over-the-counter without further delay." On August 24-,20-06, F'DA`approved Baii' s
marketing for those ages 18 and older, and remains available by prescription for"women age s
17 and younger. Additional information is available on FDA's website at:
http : //www . fda .gov/cder/drugs/infopage/P1anB/default. htm
Thank you for your letter and your continued interest in this issue." If we can be of further
Sincerely,
David W . Boyer
Assistant Comm issioner
for Legislation

Rockville MD 20857
SEP 16 2006
The Honorable Diana DeGette

Washington, D . C . 20515-060 1
Dear Ms . DeGette :
This is in response to your letter dated July 13, 2006, co-signed by 45 of your collea'gues ;
17 and younger.. Additional information is available on FDA's websife at :
http://Wwwfda .govlcderldrugslinfopagelPlanBldefault.htm
Sincerely,
. Boyer
for Legislation

Rockville MD 20857
SEP 15 200 6
.The Honorable Rick Larsen

Dear Mr . Larsen :
status of Barr Laboratories' application to make EC (emergency contraception) availabl e. .
, ._ ..
over-the-counter without fu rther delay." On August 24, 2006, FDA approved 'Barr' s
17 and younger . Additional information is available on FDA's _ webs'tte
. at:
http : //wwvv.fda .gov/cder/drugs/infopage/PlanB/default.htm
Sincerely ,
vid W . Boyer
for Legislation
J *, Sctvtctt .p't
+
r
a
= DEPARTMENT OF HEALTH & HUMAN SERVICES

~ _ .
°t►..a
Rockville MD 20857
SEP 15 2006
. The Honorable Joseph Crowley

Dear Mr . Crowley :
supplemental new drug application. As a result, Plan B is approved for over-the-counter
17 and younger. Additional information is available on FDA's website at :
http : //www .fda .gov/cder/drugs/infopage/Pl anB/defaul t . htm
Sincerely ,
D&Vrid W . Boyer
for Legislation

Rockville MD 20857
SEP 15 200 6
. The Honorable Mark Steven Kirk
Washington, D .C . 20515-13 1 0
Dear Mr. Kirk :
This is in response to your le tter dated July 13, 2006, co-signed by 45 of your colleagues ;
in which you as ked the Food and Drug Administration (FDA) to "render a decision on the
http: //www.fda .gov/cdeY/drugs/infopage/PlanB/default. htm
Sincerely,
avid W. Boyer
for Legislation

Rockville MD 2085 7
SEP 1 6 2006
• The Honorable Dennis Moore
Dear Mr. Moore :
over-the-counter without fu rther delay." On August 24, 2006, FDA approved Barr's
marketing for those ages 18 and older, and remains available
_ by prescription
_ for women age s
17 and younger. Additional information is available on pDA's website at :
h ttp : //www.fda.gov/cder/d rugs/infopage/PIanB/default . htm
Sincerely,
D01-d W . Boyer
Assistant Commissione r
for Legislation

Rockville MD 2085 7
SEP 1 5 200 6
. The Honorable Brad Miller

Dear Mr. Miller:
http ://www.fda .govlcderldrugslinfopagelPlanBldefault . htm
Sincerely ,
Da*idW . Boyer
for Legislation

Rockville MD 2085 7
SEP 15 2006
The Honorable Raul M . Grijalva

Dear Mr. Grijalva :
in which you asked the Food and Drug Administration (FDA) to "render a decision on - the
over-the-counter without further delay." On August 24, 2006, FDA approved Barr's
http : //www.fda.gov/cder/drugs/infopage/PIanB/default . htm
Sincerely,
W . Boyer
for Legislation
N SIRhe[J .
~ DEPARTMENT OF HEALTH & HUMAN SERVICE S
~'ktrv~ra ~
Rockville MD 20857
SEP 15 2006
. The Honorable Ed Case
Dear Mr. Case :
in which you asked the Food and Drug Administration (FDA) to "render a decision _on'the
over-the-counter without further delay." On August 24, 2006, FDA approved Barr's '
h ttp ://www.fd a. go v/cder/drugs/i nfopage/PI anB/d efa u l t . h tm
Sincerely,
- v~
id W . oyer
for Legislation

Rockville MD 2085 7
SEP 15 200 E
. The Honorable Maurice D . Hinchey
Dear Mr . Hinchey:
in which you asked the Food and Drug Administration (FDA) to "render a "decision on the
over-the-counter without further delay ." On August 24, 2006, FDA approved Barr's-
http: //www.fda .gov/cder/drugs/infopage/PlanB/default . htm
Sincerely,
. Boyer
for Legislation

Rockville MD 2085 7
SEP 15 200 6
. The Honorable Patrick J. Kennedy
Dear Mr . Kennedy :
over-the-counter without fu rt her delay." On August 24, 2006, FDA approved Barr's ~
17 and younger . Additional information is available on FDA's website
... at : _ . ,
http: //www.fda.gov/cder/drugs/infopage/PlanB/default .htm '
Thank you for your letter and your continued interest in this issue . ' If we _can be of further
signers of your le tt er.
Sincerely ,
'avid W. Boyer
for Legislation
~',~ SE6vlf~d,G
p J1
0 ,
s

Rockville MD 20857
SEP 15 200 5
The Honorable Rush D . Holt
Dear Mr . Holt :
in which you asked the Food and Drug Administration (FDA) to "cerider a'decision on th e
over-the-counter without further delay." On August 24, 2006, FDA approved Barr's '
supplemental new drug application . Asa result, Plan B is approved for over-the-counter'-
marketing for those ages 18 and older, and remains available by presc ri ption for women ages
h ttp : //www.fda .gov/cder/d rugs/infopage/PlanB/defaul t . htm
Sincerely,
avid W . Boyer
for Legislatio n
Jd'~Sitv~cp..G~ .

r0
. . .. . . .. . . .. . . . . . . . .. ~
~~tYrtra
Rockville MD 2085 7
SEP 1 6 2006
The Honorable John Conyers, Jr .

Dear Mr . Conyers :
over-the-counter without further delay." On August 24, 2006, FDA approved Baii's
supplemental new drug application . As a result, Plan B is approved for over-the-counter-
http : //www . fda .go v/cd er/drugs/infopage/PlanB/defaul t . ht m
assistance, ple as e let us know. A similar response is being sent to each of the other co-
Sincerely ,
DGid W . Boyer
for Legislation
DEPARTMENT OF HEALTH & HUMAN . SERVICES .

Rockville MD 20857
SEP 1 5 200 6
. The Honorable Mark Udall
W ashington, D .C . 20515-060 2
Dear Mr. Udall :
status of Barr Laboratori es' application to make EC (emergency contraception) available
over-the-counter without further delay ." On August 24, 2006, FDA approved Ban's
http ://www.fda.gov/cder/drugslinfopage/PlanB/default . htm
Sincerely,
W . Boyer
for Legislation
DEPARTMENT OF HEALTH & .. HUMAN SERVICES .

Rockville MD 20857
SEP 15 2006
. The Honorable Nancy L . Johnson
Dear Ms . Johnson :
status of Barr Laboratori es' application to make EC ( emergency contraception) available
over-the-counter without fu rther delay." On August 24 ~2006 2006, FDA aPproved B
an''s
17 and younger. Additional information is available -on FDA's website at:
http : //www.fda .gov/cder/drugs/infopage/PlanB/default . htm
as sistance, please let us know . A similar response is being sent to each of the other co-
W . Boyer
for Legislation
. . .
J~~ 55xSICfS,4'
S f
~ DEPARTMENT OF HEALTH & HUMAN .SERVICES . . . . _ . . . . ..
5 ~
M4r~m
Rockville MD 2085 7
SEP 1 5 200B
. The Honorable Janice D . Schakowsky

Dear Ms. Schakowsky:
marketing for those ages 18 and older, an d remains available by prescription for women ages
http ://www.fda.gov/cder/drugs/infopage/PlanB/default . htm
Sincerely,
id W . Boye r
for Legislation
DEPARTMENT OF HEALTH & HUMAN . SERVICES ,

Rockville MD 20857
SEP 1 5 200 6
The Honorable Martin T . Meehan

Dear Mr. Meehan :
in which you asked the Food and D ru g Administration (FDA) to "render a decision on the
marketing for those ages 18 and older, an d remains available by prescription for women ages
17 and younger . Additional information is available on FDA's website at:
http : //www.fda.gov/cder/drugs/infopage/PlanB/default . htm
as sistance, ple as e let us know . A similar response is being sent to each of the other co-
Sincerely,
avid W . Boyer
for Legislation
DEPARTMENT OF HEALTH & HUMAN SERVICES .

Rockville MD 20857
SEP 15 2006
. The Honorable Thomas H . Allen

Dear Mr . Allen:
This is in response to your letter dated July 13, 2006, co-signed by 45 of your colleagues ,
. . ._, .:.. . _ . _
.inwhcyouaskedtFnDrugAdmistaon(FDA)"reida_cson
.the
over-the-counter without further delay." On August 24, 2006, FDA _ approved Barr's
17 and younger . Additional information is available on FDA's website at :+
Thank'you for your letter and your continued interest in this issue . If we can be of further
Sincerely,
id W . Boyer
for Legislation
DEPARTMENT OF HEALTH & HUMAN, SERVICES

Rockville MD 20857
SEP 1 5 20DO
. The Honorable Bob Filner

Dear Mr. Filner :
in which you asked the Food and Drug Administration ( FDA) to "rerider a decision on the
status of Barr Laborato ri es' application to make EC (emergency contracepti on) available
supplemental new d ru g application . As a result, Plan B is approved for over-the-counter
marketing for those ages 18 and older, and remains available by presc ription
_ for women
. _, age s
http : //www.fda .gov/cder/drugs/infopage/PlanB/default . ht m
for Legislation

Rockville MD 20857
SEP 15 2006
The Honorable Robert Wexler
Dear Mr . Wexler :
status of Barr Laboratories' application to make EC (emergency contraception) availabl e
over-the-counter without further delay." On August 24, 2006, FDA approved Barr' s
marketing for those ages 18 and older, and remains available by prescription for women age s
http : //rvww.fda .gov/cder/drugs/infopage/PlanB/default . htm
Sincerely ,
id W . Boyer
for Legislatio n
0 SEYYI[".
Ile
DEPARTMENT OF HEALTH_ .&. . HUMAN SERVICES_
~1~YI)G
Rockville MD 2085 7
S EP 15 2000
. The Honorable Lois Capps

Dear Ms . Capps :
status of Barr Laboratories' application to make EC ( emergency contraception) available
over-the-counter without fu rther delay ." On August 24, 2006, FDA approved Barr's
http : //www.fda .gov/cder/drugs/infopage/PlanB/default. htm
assistance, pleas e let us know . A similar response is being sent to each of the other co-
Sincerely ,
avid W . Boyer
for Legislation

Rockville MD 20857
S EP 15 2005
, The Honorable Steven R . Rothman

Washington, D . C . 20515-300 9
Dear Mr. Rothman :
Sincerely,
avid W. Boyer
for Legislation

Rockville MD 20857 - -
SEP 15 2006
, The Honorable Sherrod Brown
Dear Mr . Brown :
This is in res onse to your letter dated July 13 2006 co-sined by 45 of our collea es -
in which you asked the Food and Drug Administration (FDA) to-` render a decision on the-'
status of Barr Laboratories' application to make EC (emergency contraception) availabl e
over-the-counter without further delay ." On August 24, 2006 ; FIIKappiioved Bair s___
supplemental new drug application . As a result, Plan B 'is approved for over-the-counter
marketing for those ages 18 and older, and remains available by prescription for. women
. .. . age
. ., .; .._ s .__
_ .,.
17 and younger . Additional information is availableon FDA's website at :
http ://www fda .gov/cdet/driigs/infopage%Ptan$%defauli .htm -,~ `-- ~
Thank you for your letter and your continued interest in this issue . If we
. can be of further
assistance, ple as e let us know . A similar response is being sent to each of the other co-
Sincerely ,
vid W . Boye r
for Legislation
lir:rAximLNi UrMtu,in aL_M)cvuN brxviLLb

Rockville MD 2085 7
SEP 1 6 2006
. The Honorable Earl Blumenauer

Dear Mr. Blumenauer :
in which you asked the Food and D rug Administration (FDA) to "render a decision on the
marketing for those ages 18 and older, an d remains available by prescri ption for women ages
http: //www.fda.gov/cder/drugs7infopage/PIanB/default. ht m
Sincerely,
avid W . Boy
for Legislatio n
DEPARTMENT OF HEALTH & HU11'iAN, SERVICES,

Rockville MD 20857
SEP 16 2006
. The Honorable Jay Inslee
Dear Mr. Inslee :
http : //www.fda . go v/cder/drugs/infopage/PlanB/defaul t . htm
Sincerely,
vid W . Boye
for Legislation
~*~ scancr,r.~
'Tr
f 0', DEPARTMENT OF HEALTH & HUMAN SERVICES .
G
Rockville MD 2085 7
SEP 15 2006
. The Honorable Lloyd Doggett
Washington, D.C . 20515-432 5
Dear Mr . Doggett:
http : //rwvw .fda .gov/cder/drugs/infopage/P1anB/default . htm
Thank you for your letter and your continued interest in this issue. If we can be of further
Sincerely,
avid W . Boyer
for Legislation
DEPARTMENT OF HEALTH & HUMAN SERVICES _

Rockville MD 20857
S EP 16 2006
. The Honorable Tammy Baldwin
Dear Ms . Baldwin :
marketing for those ages 18 and older, and remains available Fiy prescription for women ages
Sincerely,
avid W . Boyer
for Legislation

Rockville MD 20857
SEP 15 2006
. The Honorable Jim Costa

Dear Mr. Costa:
in which you asked the Food and Drug Administration (FDA) to 'render a decision on the
supplemental new drug application. As a result, Pl an B is approved for over-the-counter
17 and younger . Additional information is available on FDA's website at:
http ://www .fda .gov/cder/drugs/infopage/PIanB/default .htm '
Sincerely,
avid W . B75-y&
for Legislation

Rockville MD 20857
SEP 15 200 0
. The Honorable Lynn C . Woolsey

Dear Ms . Woolsey :
17 and younger . Additional information is available on-FDA's Nwibsite-k
http ://www.fda.gov/cderldrugs/inf opage/PranB/default . htm
Sincerely,
Gd W . Boyer
for Legislation
-. , 11
1J
, 1MC
4 ,1
`
~ DEPARTMENT OF HEALTH & HUMAN SERVICES
ve 1u
Rockville MD 20857
SEP 15 200 6
• The Honorable Jane Hannan

Dear Ms . Harman :
in which you asked the Food and Drug Administration (FDA) to "render a decision on th e
. ._ _._ _ .
status of Barr Laboratories' application to ina~Ce EC (emergency contraceptio n_ ). -available
over-the-counter without further delay." On August 24, 2006, FDA approved jBaitrs
marketing for those ages 18 and older, and remains available y prescription for women age s
. _. . ._ . _ _.. ~
17 and younger . Additional information is available on FDA's website'at :
. ._,_ ._ ...~_ , .__ .
http : //www.fda.gov/cder/drugs/infopage/PlanB/default . htin
Thank you for your letter and your continued interest in this issue. If we can be of further
Sincerely,
vid WBoye
for Legislation
~pt~'►t7a
Rockville MD 20857
SEP 15 2006
• The Honorable Henry A. Waxman

Washington, D .C . 20515=053 0
Dear Mr. Waxman :
in which you asked the Food and Drug Administration (FDA) to "render a decision on th e
status of Barr Laborato ri es' application to make EC ( emergency contraception) available
17 and younger. Additional information is available on FDA's web-site at :
http ://www.fda.govlcderldrugslinfopagelPlanBldefault. htm
Sincerely,
W. Boyer
for Legislation

CREW: Food and Drug Administration - Plan B: OL1

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~tnited oStates

We note that Plan B contains . much ..higher-_doses of hormones

• Please provide a detailed,analysis

• In August of 2006, the Director of CDER concluded

• Please provide a copy of any Executive Branch communications regarding the

Carr my.., Vyl

From : Susan Thaul [STHAULQcrs .loc .gov]

1 . What group, if any, is responsible for enforcing that distinction ?

3 . What group, if any, is responsible for determining when It does happen?

6A . Could an adult male buy the OTC drug ?

7 . If an Individual purchases a prescription drug (according to a valid prescription

Thank you . -Susan

telephone : (202) 707=0562

August 23, 200 6

Andrew von Eschenbach

Dear Dr. von Eschenbach :

The Subcommittee on Criminal Justice, Drug Policy and Human Resources

511 ~MBi dA0

Dr. Andrew C . von Pschonbach

Dcar Dr. von Eschcnbaah :

Andrew C. von Eschenbach, M .D .

Dear Commissioner von Eschenbach :

Also, by allowing women to use Plan B . without a prescription and physician

Food and Drug Administration

Dear Mr. Jones :

As you noted in your letter, Plan-B contains an ingredient

Page 2 - The Honorable Walter B . Jones

President Pro Tempore

Enclosed is a copy of a letter I received fron~~~s o .

With best wishes,

Anchorage Fairbanks Juneau Wasilla Kenai Ketchikan Bethel

<IP>209 .193 .21 .76</IP >

. The Honorable Ted Stevens

Dear Senator Stevens :

(gIIIT g TPa ,S of t4 P UIIt tPh §tFCtPs

Dear Dr_ von Eschenbach:

Access to emergency contraception decreases

r1MlSik -Sleven Kirj/ "s Moore

Patrick Kennedy Rush Holt

C yn Maloney r/ Danny Davis

Food and Drug Administration

, The Honorable Christopher Shays

• The Honorable Louise M . Slaughter

Food and Drug Administration

• The Honorable Rob Simmons

Dear Mr. Simmons :

Food and Drug Administration

. The Honorable Judy Biggert

Food and Drug Administration

The Honorable Diana DeGette

Food and Drug Administration

.The Honorable Rick Larsen

= DEPARTMENT OF HEALTH & HUMAN SERVICES

. The Honorable Joseph Crowley

Food and Drug Administration

Dear Mr. Kirk :

Food and Drug Administration

Dear Mr. Moore :

Food and Drug Administration

. The Honorable Brad Miller

Dear Mr. Miller:

Food and Drug Administration

The Honorable Raul M . Grijalva

Dear Mr. Grijalva :