CREW: Food and Drug Administration - Plan B: OL2

DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration

Rockville MD 20857
SEP 15 2006
. The Honorable Linda T . Sanchez

House of Representatives
Washington, D .C . 20515-053 9
Dear Ms . Sanchez :
This is in response to your letter 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 decisioi ori tfie -J
status of Barr Laborato ri es' 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-counter
marketing for those ages 18 an d older, and remains available by prescription for women
. ._:_ . .:_ .._ages
.. .
17 and younger . Additional information is available ori FLSA's we6site at :
http: //www.fda .gov/cder/drugs/infopage/PIanB/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,
avid W . Boy
Assistant Commissioner
for Legislation
,~*p ssxv+car.o~
~ld1~3G
Rockville MD 20857
SEP 15 2006
. The Honorable Albert R . Wynn

Dear Mr. Wynn :
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 th e
status of Barr Laboratories' application to make EC (emergency contraception) available
over-the-counter without further delay." On August 24, 2-W,-FDA~approved Mri's
marketing for those ages 18 and older, and remains available by prescription for woirien-ages
17 and younger. Additional information is available on FDA's website at :
http : //www.fda.gov/cder/drugs/infopage/PIanB/default . htm
signers of your letter.
Sincerely,
vid W . Boyer
for Legislation

Rockville MD 20857
SEP 1 5 2006
• The Honorable William J . Jefferson

Dear Mr. Jefferson :
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) availabl e
over-the-counter without further delay." On August 24, 2006 ; F DA 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 prescnption for women ages
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
Sincerely,
vid W . Bo,
for Legislation
,~~ suvct, .r,~
~.,
+<,.,,a
Rockville MD 20857
SEP 1 6 2006
• The Honorable Jim McDermott

Washington, D .C . 20515-4707
Dear Mr . McDermott :
over-the-counter without further delay." On August 24, 2066, FDA approved Barr's -
supplemental new drug application . As a result, Plan Bis approved for over the=counte
rmaketingforthseags18andoler,andremains vailbe ypresciptonfrwomeag s
17 and younger . Additional information is available on FDAs website at :
http : //www.fda .gov/cder/drugs/infopage/PlanB/default . htm
assistance, please let us know. A similar response is being sent to each of the other co-
Sincerely,
ssistant Commissioner
for Legislation
=JF' V
Md+re3a Food and Drug Administration

Rockville MD 20857
SEP 1 5 200 6
, The Honorable James P . Moran

Dear Mr . Moran :
, . .. . _ . . _ _ _
in which you asked the Food and Drug Administration (FDA) to "render a decisio n on the
status of Barr Laboratories' application to make EC (emergency contraception)
.. . available .,. ._.
,_ : ._ ~
over-the-counter without further delay.„ On August 24, 2006, FDA'approved_. garr s
supplemental new drug application. As a result, Plan B is approved forover the-counter
marketing for those ages 18 and older, and remains available by prescript'ion for-women ages
17 and younger . Additional information is available on FDA's webstte af :
http : //www.fda .gov/cder/drugs/infopage/PZanB/default .htm
assistance, please let us know . A similar response is being sent to each of the other co
Sincerely,
vid W . Bo
for Legislation"
#*N S[lY1Ctt.4
0d rt
~t+v ad
Rockville MD 20857
SF P 15 2006
. The Honorable Jerrold Nadler

Dear Mr. Nadler:
This is in response to your le tter dated July 13, 2006, co-signed by 45 of your colleagues,
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 ages
http : //www.fda.gov/cder/drugs/infopage/PIanB/default . htm
Thank you for your letter and your continued interest in this issue . If we can be of fu rther
Sincerely ,
avid W-Bo'
for Legislation
'N StiVl[(r_G
pP ~I
~ttrno
Rockville MD 20857
S EP 15 2006
. The Honorable Donald M . Payne

Washington, D.C . 20515-301 0
Dear Mr . Payne :
This is in response to your lett er 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' 8pplication to make EC (emergency contracep tion) available
over-the-counter without further delay ." On August 24, 2006, FDA: approved ~arr' s
supplemental new d rug application . As a result, Plan B is approvedµfor over tne=counter - "
marketing for those ages 18 and older, and remains available by prescnption for women ages
. :._ ... ; ._ . . . . . . . . .. . .. . . . . .
17 and younger . Additional information is available on FDA's website at :-
http : //www.fda. go v/cder/drugs/infopage/PIanB/defaul t . htm
Sincerely,
er
for Legislation
yt'vaa
Rockville MD 2085 7
SEP 15 200 6
. The Honorable Carolyn B . Maloney

Dear Ms . Maloney :
This is in response to your letter dated July 13, 2006, co-signed by 45 ofyour colleagues,
in which you asked the Food and Drug Administration (FDA) to ` render a d6cision on the
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-counter
marketing for those ages 18 and older, and remains available by -prescri ption for women ages
__
http : //www.fda.gov/cder/drugs/infopage/PlanB/default .htm
assistance, please let us know . A similar response is being sent to each ofthe other co-
Sincerely ,
W . Boy
Assistant Comnirs-sioner
for Legislation

Rockville MD 20857
SEP I s . 2006
. The Honorable Julia Carson

W as hington, D .C . 20515-140 7
Dear Ms . Carson :
in which you asked the Food and Drug Administration (FDA) to "render a decision on tfie
over-the-counter without further delay ." On August 24, 2006, FDA :approved~$arr' s
supplemental new drug application . As a result, P1an B is approved for over-the-counter
.
marketing for those ages 18 and older, and remains available by prescription for -w'omen ages W
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
Sincerely,
for Legislation
J+*+, 560
.v7G{,.4' . .
r f
DEPARTMENT OF HEALTH & . HUMAN SERVICES

Rockville MD 20857 `
SEP 15 200 6
. The Honorable Danny K . Davis

Dear Mr. Davis :
This is in response to your lett er dated July 13, 2006, co-signed by45 of_your colleagues,
in which you asked the Food and Drug Administration (FDA) to ' render a decision on the
status of Barr Laboratori es' application to make EC (emergency contraception) available
over-the-counter without fu rther delay." On August 24, 2006, 'FL)Aappr`oved Ba`rYs '
,_ . :.,
supplemental new drug application . As a result, Plan B is' approved for over-66-counter
marketing for those ages 18 and older, and remains available by presc ri ption for women ages
17 and younger. Additional information is available on FDA's web -site 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
Sincerely ,
d W . Boye
for Legislation
~ ssmcer."
Ile 17
~.,
ra
Rockville MD 20857
S EP 15 200 6
.The Honorable Russ Ca rn ahan
Washington, D .C. 20515-250 3
Dear Mr. Carnahan :
This is in response to your letter dated July 13, 2006, co-signed by 45 of yourcolleagues,
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, FDAyappi oved 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 prescription for women
.,.K _ . r . _ _ -:. .~ .. ... _ . age
_ .~ --s -
17 and younger. Additional information is availaEile: on FDA's- w.ebs,tte at :
http: //www.fda .gov/cder/drugs/infopage/PlanB/default . htm
Thank you for your letter and your continued interest in this issue. Ifwe can be~of further
Sincerely,
VI w
id W . B o
for Legislation
t~ ~
e f _ . . . .. .- . . __ . . . . . ._ . . . . ._ .. . .._ . . ._. . .. . . . ._ . . .... .

3 _ . . . . . . .. .. . .. _ _._ . _ . . .,_ . . . . - w.-:. .~ .,.~: .:~..
N ra
Rockville MD 20857
SEP 16 200B
. The Honorable Steve Israel

Dear Mr. Israel :
This is in response to your letter dated July 13, 2006, co-signed

_ r.~. by 45 of your colleagues,
.~_ . . . _ . ~. _ . . .
in which you asked the Food and Drug ArTininistiiation
. _ ~FDA} to "re_nder a decision :: .. . ._ ._~. .~ .on _..the
::,A----- . -.,
status of Barr Laboratories' application to make EC (emergency contraception) available .- :.,
over-the-counter without further delay ." Ori August 24; 2006; "F'bA approved-arr's `-"'- ~
, -
supplemental new drug application . As- a resulf, Plan B is'approvedor over-the-counter
1
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%Plan~%default . htm
Thank you for your letter and your continued interest in this issue. If we can be of further
as sistance, ple as e let us know . A similar response is being sent to each of the other co-
Sincerely,
MEL MARTINEZ COMM ITTEES :
FLORIDA . AGING
(202) 224-3041 BANKING
ENERGY AND NATURAL RESOURCES
'United ~5tates *nate FOREIGN RELATION S
WASHINGTON, DC 20510-090 6
June 15, 2006
Mr . David Boye r
Assistant Commissioner for Legislation
Food and Drug Administratio n
15B-31 Parklawn Building
5600 Fishers Lane
Rockville, Maryland 2085 7
Dear Mr . Boyer :
I am contacting you on behalf of my constituent, Ms . x

3~-- (0
Ms . Mw s concerned about FDA's handling of Plan B emergency contraceptives . I am
enclosing her correspondence for your review. Please address your response to her directly.
Thank you for your attention to this matter. Please do not hesitate to contact me with any
questions or comments .
Sincerely,
Mel Martine z
United States Senator
MM/tlm
Enclosure
?-9p& - S3R~
= J~ ~ DEPARTMENT OF HEALTH & HUMAN SERVICE S
rM1, . . .. . . _ _ . .. .
Ml+rtaa
Rockville MD 2085 7
JUL. 1 I 200 6
Dear Ms .
Thank you for your le tter of February 16, 2006, addressed to Senator Mel Ma rtinez
regarding the processing, by the Food an d Drug Administration (FDA or the Agency), of
the supplemental new drug application fr om Barr Laboratories (now owned by Duramed
Research, Inc .) that proposes to change the marketing status of the drug, Plan B, from
prescrip ti on only to over-the-counter (OTC) . Senator Mart inez has asked us to respond
directly to you .
FDA is charged by Congress with reviewing new drug applications (NDA) to determine a
proposed new product's safety and effectiveness for the uses put forth by the manufacturer in
the application . As a science-based agency, it is FDA that must make that final
determination on whether an application for a product adequately demonstrates that the data
presented supports the proposed uses stated by the manufacturer in the proposed labeling . A
product cannot be approved until FDA determines that the product is safe and effective for the
indications stated in the proposed labeling .
Some individuals have referenced the 23-4 vote taken at the joint advisory committee meeting
in December 2003, recommending that Plan B be sold OTC . Advisory committee opinions
are only advisory in nature and are not binding on the Agency, since the final determination
on any NDA always is the responsibility of FDA . It is up to the Agency to clarify any
unanswered questions that may remain after the close of an advisory committee meeting or
that were identified during the meeting, even though a vote may have been taken on the main
question(s) before the committee . The busy schedules of the committee members require that
advisory committee meetings be scheduled well in advance . We certainly value the input
from advisory committee members and the opportunity to hear an exchange of ideas on
proposed new products from experts in their respective scientific fields . It should not be
presumed, however, that a favorable vote by an advisory committee automatically means that
a product is ready to go to the pharmacy shelves .
We would like to take this opportunity to clarify below the current status of the Agency's
activities concerning the application of the sponsor, to change the marketing status of Plan B
_. _-
Page 2-
from prescription only to OTC . In May of 2004, FDA completed its first review of the NDA
to switch Plan B to OTC, and concluded that the application could not be approved at that time
because : 1) adequate data were not provided to support a conclusion that young adolescent
women can safely and effectively use Plan B for emergency contraception without the
professional supervision of a licensed practitioner, and 2) an amended proposal submitted by the
sponsor during the review cycle to change the requested indication to allow for marketing of
Plan B as a prescription only product for women under 16 years of age and a nonprescription
product for women 16 years and older was incomplete and inadequate for a' full review. This
message was conveyed to the sponsor by the then-Acting Director of FDA's Center for Drug
Evaluation and Research (CDER) with a full explanation of the reasons behind FDA's decision
in a Not Approvable letter dated May 6, 2004, (copy enclosed) and available online at :
(www.fda .gov/cder/drug/infopage/p1anB_N.4Letter.pdf)
That decision by the Acting Director of CDER was made after full review of all the underlying
data and analysis and after discussions with all of the appropriate Agency personnel . This
decision was based on his assessment that the data in the supplemental application did not
contain sufficient information about whether younger adolescent women could understand the
label and use the product safely and effectively for emergency contraception without the
professional supervision of a licensed practitioner. Therefore, the data in the application did not
support approval of the supplement . In its Not Approvable letter to the sponsor, FDA outlined
some additional information that would be required for approval to market Plan B as an OTC
drug . The issuance of a Not Approvable letter did not mean that a supplemental application
could not or would not be approved in the future .
In July 2004, the drug's sponsor amended the supplemental application seeking to make Plan B
an OTC product for women age 16 and over, and to have it remain prescription only for women
under age 16. The company also sought to market Plan B in a single package, and sold either as
prescription only or OTC, depending on the age of the purchaser .
In August 2005, FDA wrote a letter to the Duramed Research, Inc ., (copy enclosed and available
at : http ://www.fda.gov/cder/drug/infopage/p1anB/Plan_B letter20050826 .pdJ) stating that FDA
had completed its review of the application and that the scientific data supported the safe and
effective use of Plan B as an OTC product for women ages 17 and over. FDA also stated,
however, that it was unable at that time to reach a final decision on the approvability of the
application due to unresolved issues that related to the application .
In the letter to the sponsor, FDA identified three difficult and novel issues presented by the
application, issues for which the Agency is committed to a process for resolving . That
process was initiated with the publication on September 1, 2005, of an Advance Notice of
Proposed Rulemaking (ANPRM) in the Federal Regisier seeking comment on questions related
to section 503(b) of the Federal Food, Drug, and Cosmetic (FD&C) Act (Title 21, United States
Code 353(b) . The questions the interested parties were asked to respond to concern when an
active ingredient of a drug may be simultaneously marketed as both a prescription and as an
OTC drug product, whether and how OTC availability of a product could be restricted to a
particular subpopulation, and whether the same packaged product could be sold either as
prescription only or OTC, depending on the age of the purchaser . A related concern is how, as a
practical matter, an age-based distinction could be enforced .
Page 3 ,
As the Agency has said many times during the course of the review of this application, the
questions that FDA was asked to answer, and the proposal that was put forward by the sponsor,
presented the Agency with many very difficult and novel policy and regulatory questions . In
some cases, the questions requiring an FDA response were unprecedented for this Agency .
An ANPRM is a mechanism to ask for public comments on whether the Agency should initiate a
rulemaking to codify our interpretation of section 503(b) of the FD&C __ Act regardin g_ when an
active ingredient can simultaneously be marketed in both a prescription drug product and an
OTC drug product for the same indication, strength, dosage form and route of administration .
Although the Agency typically solicits public comment for a minimum . .. .~ . of 90 ..days
. whe n
initiating this type of process, in the interest of moving quickly on this issue, the comment ._., period
was shortened to 60 days for this ANPR .M. The public comment period on these questions
closed as of November 1, 2005, and FDA is reviewing the comments and letters it received .
While we cannot put an exact timeline on how long it will take to process these comments, we
are committed to moving forward as quickly as possible .
Notwithstanding the outcome of the rule making process, there._ remain deficiencies in the
sponsor's application . For example, as set forth in the letter FDA sent to Duramed Research,
Inc ., on August 26, 2005, while the application sought approval for the switch for ages 16 and
older, CDER found that the data supported only for ages 17 and older . Moreover, the outcome
of FDA's rulemaking process may impact the approvability of the proposed packaging and the
use of age as a criterion on which to base a distinction between OTC and prescription use .
Accordingly, Duramed may need to amend its supplemental application . Please note, however,
that as FDA's August 26 letter to Duramed _ _describes,.CDER
, . . has
. . . ._completed
. its scientific revie w
of their pending supplemental application .
The Agency has found that considerable misinformation has circulated about this application an d
the reasons FDA has taken the actions it has to this point . So there will be no confusion abou t
the public statements FDA actually has made concerning the Barr %Duramed Plan B/OT C
application, in addition -to the two lett ers to the sponsor mentioned above, we are enclosing
copies of the two press releases dated May 7, 2004, and August 26, 2005,` that the Agency issued
conce rn ing this application .
Thank you again for contacting Senator Martinez concerning in this matter.
Sincerely,
$ ,_ ...-- „_... . --
Da id W . Boyer
Associate Commissioner
for Legislatio n
4 Enclosure s
cc : The Honorable Mel Martinez

United States Senate
.~~. : , .. ..
MEL MARTINEZ COMMI7TEES:
FLORIDA AGIN G
(202) 224-3041 1/4*1~ BANKING

ENERGY AND NATURAL RESOURCES
'United *aten .16enate '60's'. FOREIGN RELATION S
WASHINGTON, DC 20510-0 906 ~~6+
June 12, 2006
Mr. Amit Sachde v

Associate Commissioner for Legislation
Food And Drug Administration
Parklawn Buildin g
5600 Fishers Lane, Room 1 547
Rockville, Maryland 20857
Dear Mr . Sachdev :
I am contacting you on behalf of my constituent, M~~~~
M4Ws concerned about over-the-counter approval of "Plan B" emergency

contraceptive . I am enclosing her correspondence for your review. Please address your response
to her directly .
Thank you for your attention to this ma tter . Please do not hesitate to contact me with any
questions or comments .
Sincerely,
Mel Martinez
United States Senato r
MM/tlm
Enclosure
65575
Correspondence Tracking Shee t
' Tracking # 171735-D C
.:~=u&i
~_.. ~x~... . R-1, :-4 0 ;? ;e~ 112
: Bucked Mail - Miscellaneous— Category
Campaign / Group : Plan B
Assigned To : Frank C . Walker
Status : Queued
Received"bia :-- - Web
Date Received : 03/29/2006
Web Mail Subject : FDA - Plan B
I want you to take whatever steps you can to ensure that the FDA approves
Plan B . It is not an abortion pill and has no effect on existing pregnancy .
The FDA was never given any mandate to enforce social policy .
Thank youll1lip p
Notes/Comments :
Route History :
06/12/2006 - 04 :31 PM - Terrance Massey - Printed Tracksheet
6/12/2006 4 :30 :53 PM - Terrance Massey - Status Change : Queued
6/12/2006 4 :29 :32 PM - Terrance Massey - Created Response
5/9/2006 1 :30 :23 PM - Jenn Gallagher - Updated via Modify Fields
5/9/2006 1 :30 :23 PM - Jenn Gallagher - Assigned to Frank C . Walker
03/29/2006 01 :11 :59 PM - Created manually by Brianne Jablon via lnterTrac WebMail .
InterTrac Tracksheet 01 1 06/12/2006


Rockville MD 2085 7
JUL 1 1 200 6
Dear Ms
Thank you for your letter of March 29, 2006, addressed to Senator Mel Ma rtinez regarding
the processing, by the Food and Drug Administration (FDA or the Agency), of the
supplemental new drug application (NDA) from Barr Laboratories (now owned by Duramed
Research, Inc .) that proposes to change the marketing status of the d ru g, Plan B, from
prescription only to over-the-counter (OTC) . Senator Martinez has as ked us to respond
directly to you .
FDA is charged by Congress with reviewing NDAs to determine a proposed new product's
safety and effectiveness for the uses put forth by the manufacturer in the application . As a
science-based agency, it is FDA that must make that final determination on whether an
application for a product adequately demonstrates that the data presented supports the
proposed uses stated by the manufacturer in the proposed labeling . A product cannot be
approved until FDA determines that the product is safe and effective for the indications stated
in the proposed labeling .
Page 2
from prescription only to OTC . In May of 2004, FDA completed its first review of the NDA
to switch Plan B to OTC, and concluded that the application could not be approved at that time
because : 1) adequate data were not provided to support a conclusion that young adolescent
women can safely and effectively use Plan B for emergency contraception without the
professional supervision of a licensed practitioner, and 2) an amended proposal submitted by the
sponsor during the review cycle to change the requested indication to allow for marketing of
Plan B as a prescription only product for women under 16 years of age and a nonprescription
product for women 16 years and older was incomplete and inadequate for a full review . This
message was conveyed to the sponsor by the then-Acting Director of FDA's Center for Drug
Evaluation and Research (CDER) with a full explanation of the reasons behind FDA's decision
in a Not Approvable letter dated May 6, 2004, (copy enclosed) and available online at :
(www.fda.gov/cder/drug/infopage/p1anB_NALetter .pdJ)
decision was based on his assessment that the data in the supplemental application did not
contain sufficient information about whether younger adolescent women could understand the
label and use the product safely and effectively for emergency contraception without the
professional supervision of a licensed practitioner. Therefore, the data in the application did not
support approval of the supplement . In its Not Approvable letter to the sponsor, FDA outlined
some additional information that would be required for approval to market Plan B as an OTC
drug. The issuance of a Not Approvable letter did not mean that a supplemental application
could not or would not be approved in the future.
In July 2004, the drug's sponsor amended the supplemental application seeking to make Plan B
an OTC product for women age 16 and over, and to have it remain presc ription only for women
under age 16 . The company also sought to market Pl an B in a single package, and sold either as
prescription only or OTC, depending on the age of the purchaser.
In August 2005, FDA wrote a letter to the Duramed Research, Inc ., (copy enclosed an d available
at : http ://www.fda .gov/cder/drug/infopage/p1anB/Plan_B letter20050826 .pdj) stating that FDA
had completed its review of the application and that the scientific data suppo rted the safe and
effective use of Plan B as an OTC product for women ages 17 and over . FDA also stated,
process was initiated with the publication on September 1, 2005, of an Advance Notice of
Proposed Rulemaking (ANPRM) in the Federal Register seeking comment on questions related
to section 503(b) of the Federal Food, Drug, and Cosmetic (FD&C) Act (Title 21, United States
Code 353(b) . The questions the interested parties were asked to respond to concern when an
active ingredient of a drug may be simultaneously marketed as both a prescription and as an
OTC drug product, whether and how OTC availability of a product could be restricted to a
particular subpopulation, and whether the same packaged product could be sold either as
prescription only or OTC, depending on the age of the purchaser . A related concern is how, as a
practical matter, an age-based distinction could be enforced .
Page 3
sidewftV
rulemaking to codify our interpretation of section 503(b) of the FD&C Act regarding when an
active ingredient can simultaneously be marketed in both a prescription drug product and an
OTC drug product for the same indication, strength, dosage form and route of administration .
Although the Agency typically solicits public comment for a minimum of 90 days when
initiating this type of process, in the interest of moving quickly on this issue, the comment period
was shortened to 60 days for this ANPRM. The public comment period on these questions
closed as of November 1, 2005, and FDA is reviewing the comments and letters it received .
While we cannot put an exact timeline on how long it will take to process these comments, we
are committed to moving forward as quickly as possible.
Notwithstanding the outcome of the rulemaking process, there remain deficiencies in the
Inc., on August 26, 2005, while the application sought approval for the switch for ages 16 and
older, CDER found that the data supported only for ages 17 and older. Moreover, the outcome
of FDA's rulemaking process may impact the approvability of the proposed packaging and the
use of age as a criterion on which to base a distinction between OTC and prescription use .
Accordingly, Duramed may need to amend its supplemental application . Please note, however,
that as FDA's August 26 letter to Duramed describes, CDER has completed its scientific review
of their pending supplemental application .
The Agency has found that considerable misinformation has circulated about this application and
the reasons FDA has taken the actions it has to this point . So there will be no confusion about
the public statements FDA actually has made concerning the Barr/Duramed Plan B/OTC
application, in addition to the two letters to the sponsor mentioned above, we are enclosing
copies of the two press releases dated May 7, 2004, and August 26, 2005, that the Agency issued
concerning this application .
Thank you again for contacting Senator Martinez concerning in this matter .
Sincerely,
avid W . Boyer
for Legislation
4 Enclosures
cc : The Honorable Mel Martinez

United States Senate
SUNIt.F.V'Cf
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

Rockville MD 20857
The Honorable Louise M . Slaughter

Co-Chair, Bipartisan Pro-Choice Caucus
House of Representative s
Washington, D . C . 20515-3228 MAk 2 Z006
Dear Ms . Slaughter :
Thank you for the letter of September 8, 2005, co-signed by the three other Co-chairs of the
Bipartisan Congressional Pro-Choice Caucus . You express concerns about the Food and Drug
Administration's (FDA or the Agency) processing of the supplemental new drug application from
Barr Laboratories (now owned by Duramed Research, Inc .) that proposes -to change the marketing
status of the drug, Plan B, from prescription only to over-the-counter (OTC) .
Your letter referenced the 23-4 vote taken at the joint advisory committee meeting in December
2003, recommending that Plan B be sold OTC . Advisory committee opinions are only advisory
in nature and are not binding on the Agency . The final determination on any new dru g
application (NDA) always is the responsibility of FDA . It is up to the Agency to clarify any
unanswered questions that may remain after the close of an advisory committee meeting or that
were identified during the meeting, even though a vote may have been taken on the main
advisory committee meetings be scheduled well in advance . We certainly value the input from
advisory committee members and the opportunity to hear an exchange of ideas on proposed new
products from experts in their respective scientific fields . It should not be presumed, however,
that a favorable vote by an advisory committee automatically means that a product is ready to go
to the pharmacy shelves .
As you know, FDA is charged by Congress with reviewing new drug applications (NDA) to
determine a proposed new product's safety an d effectiveness for the uses put fo rth by the
manufacturer in the application . As a science-based agency, it is FDA that must make that final
product c an not be approved until FDA determines that the product is safe and effective for the
We would like to take this opportunity to clarify below the current status of the Agency' s
activities concern ing the application of the sponsor, to change the marketing status of Plan B fro m
presc ri ption only to OTC . In May of 2004, FDA completed its first review of the new drug
application to switch Plan B to OTC, and concluded that the application could not be approved at
that time because: 1) adequate data were not provided to suppo rt a conclusion that young
adolescent women can safely and effectively use Pl an B for emergency contraception
Page 2 - The Honorable Louise M . Slaughter
without the professional supe rv ision of a licensed practitioner, and 2) an amended proposal
submitt ed by the sponsor during the review cycle to change the requested indication to allow for
marketing of Plan B as a presc ription only product for women under 16 years of age and a
nonpresc ription product for women 16 years and older was incomplete and inadequate for a full
review . This message was conveyed to the sponsor by the Acting Director of FDA's Center for
Drug Evaluation and Research (CDER) with a full expl an ati on of the reasons behind FDA's
decision in a Not Approvable letter dated May 6, 2004 (copy enclosed) and available online at :
(www.fda .gov/cder/drug/infopage/p1anB_NALetter.pdf ) .
decision was based on his assessment that the data in the supplemental application did not contain
sufficient information about whether younger adolescent women could understand the label and
use the product safely and effectively for emergency contraception without the professional
supervision of a licensed practitioner . Therefore, the data in the application did not support
approval of the supplement . In its Not Approvable letter to the sponsor, FDA outlined some
additional information that would be required for approval to market Plan B as an OTC drug. The
issuance of a Not Approvable letter did not mean that a supplemental application could not or
would not be approved in the future .
In July 2004, the drug's sponsor amended its supplemental application seeking to mak e
Plan B an OTC product for women age 16 and over, and to have-- it remain prescri ptiod only for
women under age 16 . The company also sought to market Plan B in a single package, and sold
either as prescription only or OTC, depending on the age of the purchaser .
In August 2005, FDA wrote a letter to the Duramed Research, Inc ., (copy enclosed and available
at : http://www .fda .gov/cder/drug/infopage/p1anB/Plan_B Ietter20050826 .pdj) stating that FDA
had completed its review of the application and that the scienti fi c data suppo rted the safe and
application, issues for which the Agency is committed to a process for resolving . That process
was initiated with the publication on September 1, 2005, of an Advance Notice of Proposed
Rulemaking (ANPRM) in the Federal Register seeking comment on questions related to section
503(b) of the Federal Food, Drug, and Cosmetic (FD&C) Act (Title 21, United States Code
353(b)) . The questions the interested parties were asked to respond to concern when an active
ingredient of a drug may be simultaneously marketed as both a prescnption and as an-OTC dru g
product, whether and how OTC availability of a product could be restri cted to a particula r
subpopulation, and whether the same packaged product could be sold either as prescription only o r
OTC, depending on the age of the purchaser . A related concern is how, as a practical matter, an
age-based distinction could be enforced .
Page 3 - The Honorable Louise M . Slaughter
presented the Agency with many very difficult and novel policy and regulatory questions. In
active ingredient can simultaneously be marketed in both a prescription drug product and an OTC
drug product for the same indication, strength, dosage form and route of administration .
Although the Agency typically solicits public comment for a minimum
:__ of 90 days when initiating
this type of process, in the interest of moving quickly on this .issue, the comment period was
shortened to 60 days for this ANPRM. The public comment period on these questions closed as
of November 1, 2005, and FDA is reviewing the comments and letters it received . While we
cannot put an exact timeline on how long it will take to process these comments, we are
committed to moving forward as quickly as possible.
Notwithstanding the outcome of the rulemaking process, there remain deficiencies in the sponsor's
application . For example, as set forth in the letter FDA sent to Duram-ed Research, Inc ., on
August 26, 2005, while the application sought approval for the switch for ages 16 and older,
CDER found that the data supported only for ages 17 and older . Moreover, the outcome of
FDA's rulemaking process may impact the approvability of the proposed packaging and the use of
age as a criterion on which to base a distinction between OTC and-pre's'cription use . Accordingly,
Duramed may need to amend its supplemental application . Please note, however, that _ as _ . FDA's
August 26 letter to Duramed describes, CDER has completed its scieritific review-of their pending
supplemental application .
the reasons FDA has taken the actions it has to this point . So there will be no confusion about the
public statements FDA actually has made concerning the Barr/Duramed Plan B/OTC application,
in addition to the two letters to the sponsor mentioned above, we are enclosing copies of the two
press releases dated May 7, 2004, and August 26, 2005, that the Agency-issued concerning this
application .
Thank you again for your interest in this matter. If we can be of further assist ance, please let us
know . A similar response is being sent to each of the other co-signers of your letter.
Sincerely,
Patrick Rona n
for Legislatio n
4 Enclosure s
i
J+',~SLI19fQJ V
? f
•
LI
Public Health Service
i
Rockville MD 2085 7
The Honorable Rob . Si.. . .mmons .

Co-Chair, Bipart isan Pro-Choice Caucus
MAR 2 200 6
Dear Mr. Simmons :
Bipartisan Congressional Pro-Choice Caucus . You express concerns about the Food and Dru g
Barr Laboratories (now owned by Duramed Research, Inc .) that proposes to change the marketing
2003, recommending that Plan B be sold OTC .. .:Advisory
. : ~. . ._ ~. . , committee opinions are only advisory
in nature and are not binding on the Agency . The final determination on any new drug
were identified during the meeting, even though a vote may have been taken on the main
advisory committee meetings be scheduled well in, advance . We certainly value the input from
products from experts in their respective scientific fields . It should not be presumed, however,
determine a proposed new product's safety and effectiveness for the uses put forth by the
activities concerning the application of the sponsor, to change the marketing status of Plan B from
prescription only to OTC . In May of 2004, FDA completed its first review of the new drug
that time because : 1) adequate data were not provided to support a conclusion that young
adolescent women can safely and effectively use Plan B for emergency contraception
Page 2 - The Honorable Rob Simmons
without the professional supervision of a licensed practitioner, and 2) an amended proposal

submitted by the sponsor duri ng the review cycle to change the requested indication to allow for
marketing of Plan B as a presc ri ption only product for women under 16 years of age and a
nonprescription product for women 16 years and older was incomplete and inadequate for a full
review . This message w as conveyed to the sponsor by the Acting Director of FDA's Center for
Drug Evaluation and Research (CDER) with a full expl an ation of the reasons behind FDA's
(www .fda .gov/cder/drug/infopage/p1anB_NALetter .pd, f ) .
supervision of a licensed practitioner . Therefore, the data in the application did not support
additional information that would be required for approval to market Plan B as an OTC drug . The
In July 2004, the drug's sponsor amended its supplemental application seeking to mak e
Plan B an OTC product for women age 16 and over, and to have it remain prescription only for
In August 2005, FDA wrote a letter to the Duramed Research, Inc ., (copy enclosed and .available
at :' http ://www,f'da.gov/cder/drug/infopage/p1anB/Plan_B_Ietter20050826 .pdf) stating that FDA
had completed its review of the application and that the scientific . data suppo rt ed the safe and
effective use of Plan B as an OTC product for women ages 17 and over . FDA also stated,
however, that it was unable at that time to reach a fi nal decision on the approvability of the
In the letter to the sponsor, FDA identified three difficult . and novel issues presented by the
application, issues for which the Agency is commi tt ed to a process for resolving . That process
503(b) of the Federal Food, Drug, and Cosmetic (FD&C) Act ( Title 21, United States Code
353(b)) . The questions the interested pa rt ies were asked to respond to concern when an active
ingredient of a drug may be simultaneously marketed as both a presc ri ption and as an OTC drug
product, whether an4 how OTC availability of a product could be rest ri cted to a pa rticular
subpopulation, and whether the same packaged product could be sold either as presc ri ption only or
OTC, depending on the age of the purchaser . A related concern is how, as a practical ma tt er, an
Page 3 - The Honorable Rob Simmons
presented the Agency with many very difficult and novel policy and regulato ry questions . In
some cases, the questions re qui ring an FDA response were unprecedented for this Agency .
active ingredient can simultaneously be marketed in both_ a prescription drug product and an OTC
Although the Agency typically solicits public comment for a minimum of 90 days when initiating
this type of process, in the interest of moving quickly on this issue, the comment period was
shortened to 60 days for this ANPRM. The public comment period on these questions closed as
committed to moving forward as quickly as possible .
application . For example, as set forth in the letter FDA sent to Duramed Research, Inc ., on
CDER found that the data supported only for ages 17 and older . Moreover, the outcome of
FDA's rulemaking process may impact the approvability of the proposed packaging and the use of
age as a criterion on which . to base a distinction between OTC and prescription use . Accordingly,
Duramed may need to amend its supplemental application . Please note, however, that as FDA's
August 26 letter to Duramed describes, CDER has completed its scientific review of their pending
the reasons FDA has taken the actions, it has to,this point . So there will be no confusion_about_th
,epublicstamnFDAculyhasmdeoncrigthBa/DumedPlnBOTCapicto
press releases dated May 7, 2004, and August 26, 2005, that the Agency issued concerning this
application .
Thank you again for your interest in this matter . 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,
Patrick Ronan
for Legislation
4 Enclosures
r
, ~p 54riKES.4 . .

- . . _. , _ , . __ . ._ . . :
_ ~~`t►~.~a
Rockville MD 2085 7
The Honorable Judy Biggert

Co-Chair, Bipartisan Pro-Choice Caucus
Washington, D .C . 20515-131 3 MAN 2 200 6
Dear Ms . Biggert :
Bipartisan Congressional Pro-Choice Caucus . You express concerns about the Food and Drug
Barr Laboratories (now owned by Duramed Research, Inc)tfiat proposes to change the marketing
2003, recommending that Plan B be sold OTC . Advisory committee opinions are only advisory
in nature and are not binding on the Agency . The final determination on any new drug
were identified during the meeting,
.. even though a vote may have been taken on the mai n
question(s) before the commlttee . The busy_ schedules of the committee members require
._._ tha
._ t
. .~
advisory committee meetings be scheduled well in advance .- We certainly value the input from
products from experts in their respective scientific fields . It should not be presumed, however ;
activities concerning the application of the sponsor, to change the marketing status of Plan B from
prescription only to OTC . In May of 2004, FDA completed its first review of the new drug
that time because : 1) adequate data were not provided to support a conclusion that young
adolescent women can safely and effectively use Plan B for emergency contraception
f
Page 2 - The Honorable Judy Biggert
without the professional supervision of a licensed practitioner, and 2) an amended proposal

submitted by the sponsor during the review cycle to change the requested indication to allow for
marketing of Plan B as a prescription only product for women under 16 years of age and a
nonprescription product for women 16 years and older was incomplete and inadequate for a full
review . This message was conveyed to the sponsor by the Acting Director of FDA's Center for
Drug Evaluation and Research (CDER) with a full explanation of the reasons behind FDA's
(www.fda .gov/cder/drug/infopage/p1anB NALetter .pdj) .
data and analysis and after discussions withal] of the appropriate Agency personnel . This
supervision of a licensed practitioner. Therefore, the data in the application did not support
additional information that would be required for approval to market Plan B as an OTC drug . The
In July 2004, the drug's sponsor amended its supplemental application seeking to make
Plan B an OTC product for women age 16 and over, and to have it remain prescription only for
In August 2005, FDA wrote a le tt er to the Duramed Research, Inc ., (copy enclosed and available
at : http.//www.fda.gov/cder/drug/infopage/p1anB/Plan_B Ietter20050826.pdf) stating that FDA
had completed its review of the application and that the scienti fi c data supported the safe and
application, issues for which the Agency is committed to a process for resolving . That process
503(b) of the Federal Food, Drug, and Cosmetic (FD&C) Act (Title 21, United States Code
353(b)) . The questions the interested parties were asked to respond to concern when an active
ingredient of a drug may be simultaneously marketed as both a prescription and as an OTC drug
product, whether and how OTC availability of a product could be restricted to a particular
subpopulation, and whether the same packaged product could be sold either as prescription only or
OTC, depending on the age of the purchaser . A related concern is how, as a practical matter, an
questions that FDA was asked to answer, and the proposal that was put forward by the sponsor ,
i
Page 3 - The Honorable Judy Biggert
active ingredient can simultaneously be marketed in both a prescription drug product and an OTC
Although the Agency typically solicits public comment for a minimum of 90 days when initiating
this type of process, in the interest of moving quickly on this issue, the comment period was
shortened to 60 days for this ANPRM . The public comment period on these questions closed as
committed to moving forward as quickly as possible .
application . For .example, as set forth in .the letter FDA sent to Duramed Research, Inc ., on
CDER found that the data supported only for ages 17 and older. Moreover, the outcome of
FDA's rulemaking process may impact the approvability of the proposed packaging and the use of .
age as a criterion on which to base a distinction between OTC and prescription use . Accordingly,
Duramed may need to amend its supplemental application . Please note, however, that as FDA's
August 26 letter to Duramed describes, CDER has completed its scientific review of their pending
the reasons FDA has taken the actions it has to this point . So there will be no confusion about the
public statements FDA actually has made concerning the Barr/Duramed Plan B/OTC application,
press releases dated May 7, 2004, and August 26, 2005, that the Agency issued concerning this
application .
Thank you again for your interest in this matter . 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 .
Patrick Rona n
for Legislation
4 Enclosures
MICHAEL B . ENZI, WYOMING, CHAIRMA
E EDWARD M. KENNEDY,
NJUDGRE,NWHAMPSIR MASSACHUSETTS
BILL FRIST, TENNESSEE CHRISTOPHER J. DODD, CONNECTICUT
LAMAR ALEXANDER, TENNESSEE TOM HARKIN, IOWA
RICHARD BURR, NORTH CAROLINA BARBARA AMIKULSKI, MARYLAND
JOHNNY ISAKSON, GEORGIA
MIKE DEWINE, OHI O
JOHN ENSIGN, NEVADA
ORRIN G . HATCH, UTAH
JEFF SESSIONS, ALABAMA
JAMES M . JEFFORDS (II, VERMONT
JEFF BINGAMAN, NEW MEXICO
PATTY MURRAY, WASHINGTON
JACK REED, RHODE ISLAND
HILLARY RODHAM CLINTON, NEW YOR K
'United ~$tates $errate
PAT ROBERTS, KANSAS COMMITTEE ON HEALTH, EDUCATION,
LABOR, AND PENSION S
KATHERINE BRUNETT MeGUIRE, STAFF DIRECTOR
J. MICHAEL MYERS, MINORITY STAFF DIRECTOR AND CHIEF COUNSE
WASHINGTON, DC 20570-630 0
://hel p . senate .gov L ht p
September 2, 200 5
Dr . Lester Crawford
Commissioner
U .S . Food and Drug Administration
5600 Fishers Lan e
Rockville, MD 2085 7
~Ez
Dear Dr . Crawford : ti.j
I write today regarding the pending application before the Food and Drug Administration
(FDA) to make PlanB available over-the-counter on 6644e=r`estricted basis . - Your
announcement of August 26, that the FDA was ~unable to reach a 'decision on the
pending application, and would instead initiate an open-ended notice- and =comment
rulemaking, was surprising to me .
As you know, Health and Human Services Secretary Michael O . Leavitt sent me a letter
on July 13, 2005, indicating that "the FDA will act on this application by September 1,
2005 . "
Although I have concerns about wider availability of Plan B, I am deeply disappointed

that your announcement did not comport with the agreed-upon deadline for a decision .
Regarding the rulemaking, I agree that there are complex legal and regulatory questions
raised by this application . However, I note that the appfication was deemed complete
by your agency on July 21, 2004 .
It is not clear to me why it took over a year to decide that answering these legal and
regulatory questions merited a rulemaking . Many of these questions were apparent the
day the application was deemed complete . In addition, lbelieve you were aware of
these questions because you testified to their novelty and complexity during your
confirmation hearing before my committee on March 17 of this year .
Given the nature of the questions involved, and the requirements of the Administrative
Procedures Act, this rulemaking could take months ; if not years .
zo o s- 6 o 2S
Page Tw o
Dr . Lester Crawford
You have indicated that expediting this rulemaking will be a personal priority of yours .
In order to assess your attention to this issue, I request that you-answer the following
questions by September 16, 2005 .
1 . What are the next steps in your rulemaking process on this issue? Do you intend to
publish an interim final rule and then issue a final rule? Or do you intend to move
from the proposed rule directly to a final rule ?
2 . How long of a comment period do you intend to offer during each step of the
rulemaking process?
3 . Are there any steps that must be taken other than conclusion of the rulemaking
process before the FDA is able to .reach a final decision on the pending Plan B
. .. . ... . . _ . . . , . . _. : FVCV.+. w .xMa: .. . . ... .F+. . .Ain.._ . .
application ?
4 . How long after conclusion of the rulemaking process will it take for FDA to-issue- a
final decision on the pending PlanB application ?
I look forward to receiving your responses to these important questions .
Sincerely ,
Michael B . Enzi
Chairma n
cc : Secretary Michael 0 . Leavitt

V
if PETER J . VISCLOSK Y 2256 RAYBURN BUILDING

1ST DISTRICT, INDIAN A WASHINGTON, DC 20515-140 1
(202) 225-248 1
COMMITTEE ON APPROPRIATIONS
701 EAST 83RD AVENUE, SUITE 9
Tung rP as of t4je ~ni#rb § # a#P~

SUBCONIMITTEES : MERRILLVILLE, NV 4641 0
DEFENSE (2191 795-184 4
ENERGY AND WATER DEVELOPMENT
CaToll
l Froe
CONGRESSIONAL STEEL CAUCUS
VICE-CHAIRMAN ?joust of Representatilurs 1 888 423 PETE
(1 888 423-7383)
U .S . HOUSE LAW ENFORCEMENT INTERNET:

CAUCUS It as4ington, IN 211515-140 1 httP:!lwww .house .gov/visdoskYl
September 6, 200 5
The Honorable Lester Crawford

5600 Fishers Lan e
Dear Commissioner Crawford :
I write on behalf of M resident of Indiana's First Congressional District .
MsIlMas contacted me to express her concerns regarding the FDA's action s

concerning Plan B em r enc contraception . Enclosed, please find a copy of the correspondence
I have received from I would appreciate your addressing her concerns and making
her correspondence part of the official comments you receive for the proposed regulation .
Thank you in advance for your serious consideration of this matter . Do not hesitate to let
me know if you have any questions or need addjk~~ormation ,
I
Peter J. Visclosky
Member of Congres s
PJV jd E~,1
Enclosure
2.Oo S - (,plff THIS STATIONERY PRINTED ON PAPER MADE OF RECYCLED FIBERS

®®1'
Gomez-Cruz, Blyth e
From : PJV
Sent : Wednesday, August 31, 2005 2 :01 AM
To : Gomez-Cruz, Blyth e
Subject : FW: WriteRep Response s
>
>----------
>From : Write your representative[SMTP :WRITEREP@HEOC-WWW6 .HOUSE
_ . : ._.GOV J
>Sent : Wednesday, August 31, 2005 2 :01 :22 A M
>To : PJV
>Subject : WriteRep Responses
>Auto forwarded by a Rul e
>
DATE : August 31 . 200 5 01 :5C AM
NAME :
ADDR1 :
ADDR2 :
ADDR3 :
CITY :
STATE :
ZIP :
PHONE :
EMAIL :
msg :
Representative Pete Visclosky

U .S . House of Representative s
2256 Rayburn House Office Building
Washington, DC 20515-000 1
Dear Representative Visclosky ,
I am writing to voice my concern about the FDA's failure to rule on the application to
make Plan B emergency contraception (EC) available over the counter . This decision is a
major public health setback for American women . We cannot allow anti-choice ideology to
corrupt science . Please speak out against the government's willingness to sacrifice the
health and lives of women to promote a narrow ideological agenda . Call now for a hearing
to investigate this decision .
Unintended pregnancy is a significant public health problem in the United States, and
women deserve a chance to prevent it . Increased ac cess to Plan B .-emergency contraception
.____ . .. . _ .. .~ . _ ___ ~
will aTso 7ielp to~reduce ~~ need ~or a`bortion . P~an B emergency contraception is safe,
effective, and easy to use . But time is of the essence . The sooner it's taken, the better
it works . Women in this country deserve the same access that women in 38 other countries
around the world already enjoy . Millions of women, including survivors of rape, stand
ready to benefit from this opportunity .
Sincerely,
a s
Yr~~

Rockville MD 20857
The Honorable Peter J . Visclosky

Washington, D .C . 20515-140 1 FEB 2 7 Zon 6
Dear Mr. Visclosky :
Thank you for the letter of September 6, 2005, on behalf of your constituent, M s
+~e The constituent expresses concerns about the Food and Drug Administration's (FDA
or the Agency) processing of the supplemental new drug application from Barr Laboratories
(now owned by Duramed Research, Inc .) that proposes to change the marketing status of the
drug, Plan B, from prescription to over-the-counter (OTC) .
manufacturer in the application . As a science-based agency, it is FDA that must make that
final determination on whether an application for a product adequately demonstrates that the
data presented supports the proposed uses stated by the manufacturer in the proposed labeling .
A product cannot be approved until FDA determines that the product is safe and effective for
the indications stated in the proposed labeling .
from prescription only to (OTC) . In May of 2004, FDA completed its first review of the
NDA to switch Plan B to OTC, and concluded that the application could not be approved at
that time because : 1) adequate data were not provided to support a conclusion
Page 2 - The Honorable Peter J . Visclosky
that young adolescent women can safely and effectively use Plan B for emergency
contraception without the professional supervision of a licensed practitioner, and 2) an
amended proposal submitted by the sponsor during the review cycle to change the requested
indication to allow for marketing of Plan B as a prescription only product for women under 16
years of age and a non-prescription product for women 16 years and older was incomplete and
inadequate for a full review . This message was conveyed to the sponsor by the Acting
Director of FDA's Center for Drug Evaluation and Research (CDER) with a full explanation
of the reasons behind FDA's decision in a Not Approvable letter dated May 6, 2004, (copy
enclosed) and available online at : (www.fda.gov/cder/drug/infopage/planB_NALetier:pdJ) .
That decision by the Acting Director of CDER was made after full review of all the
underlying data and analysis and after discussions with all of the appropriate Agency
personnel . This decision was based on his assessment that the data in the supplemental
application did not contain sufficient information about whether younger adolescent women
could understand the label and use the product safely and effectively for emergency
contraception without the professional supervision of a licensed practitioner . Therefore, the
data in the application did not support approval of the supplement . In its Not Approvable
letter to the sponsor, FDA outlined some additional information that would be required for
approval to market Plan B as an OTC drug . The issuance of a Not Approvable letter did not
mean that a supplemental application could not or would not be approved in the future .
In July 2004, the drug's sponsor amended its supplemental application seeking to make
Plan B an OTC product for women age 16 and over, and to have it remain presc ri ption only
for women under age 16 . The company also sought to market Plan B in a single package,
and sold either as presc ri ption only or OTC, depending on the age of the purchaser.
In August 2005, FDA wrote a letter to the Duramed Research, Inc ., (copy enclosed and
available at : http ://www.fda .gov/cder/drug/infopage/planB/Plan_B_Ietter20050826 .pdJ)
stating that FDA had completed its review of the application and that the scientif c data
suppo rt ed the safe and effective use of Plan B as an OTC product for women ages 17 and
over . FDA also stated, however, that it was unable at that time to reach a final decision on
the approvability of the application due to unresolved issues that related to the application .
process was initiated with the publication on September 1, 2O05 ; of an Advance Notice of
Proposed Rulemaking (ANPRM) in the Federal Register seeking comment on questions
related to section 503(b) of the Federal Food, Drug, and Cosmetic(FD&C Act (Title 21,
United States Code 353(b) . The questions the interested parties were-asked to respond to
concern when an active ingredient of a drug may be simultaneously marketed as both a
prescription and as an OTC drug product, whether and how OTC availability of a product
could be restricted to a particular subpopulation, and whether the same packaged product
could be sold either as prescription only or OTC, depending on the age of the puretiaser : A
related concern is how, as a practical matter, an age-based distinction could be enforced .
Page 3 - The Honorable Peter J . Visclosky
questions that FDA was asked to answer, and the proposal that was put forward by the
sponsor, presented the Agency with many very difficult and novel policy and regulatory
questions . In some cases, the questions requiring an FDA response were unprecedented for
this Agency .
An ANPRM is a mechanism to ask for public comments on whether the Agency should
initiate a rulemaking to codify our interpretation of section 503(b) of the FD&C Act regarding
when an active ingredient can simultaneously be marketed in both a prescription drug product
and an OTC drug product for the same indication, strength, dosage form and route of
administration . Although the Agency typically solicits public comment for a minimum of 90
days when initiating this type of process, in the interest of moving quickly on this issue, the
comment period was shortened to 60 days for this ANPRM . The public comment period on
these questions closed as of November 1, 2005 ; and FDA is reviewing the comments and
letters it received . While we cannot put an exact timeline on how long it will take to process
these comments, we are committed to moving forward as quickly as possible .
Notwithstanding the outcome of the rulemaking process, there remain deficiencies in the
Inc ., on August 26, 2005, while the application sought approval for the switch for ages 16 and
older, CDER found that the data supported only for ages 17 and older . Moreover, the
outcome of FDA's rulemaking process may impact the approvability of the proposed
packaging and the use of age as a criterion on which to base a distinction between OTC and
prescription use . Accordingly, Duramed may need to amend its supplemental application .
Please note, however, that as FDA's August 26 letter to Duramed describes, CDER has
completed its scientific review of their pending supplemental application .
The Agency has found that considerable misinformation has circulated about this application
and the reasons FDA has taken the actions it has to this point . So there will be no confusion
about the public statements FDA actually has made concerning the Barr/Duramed Plan
B/OTC application, in addition to the two letters to the sponsor mentioned above, we are
enclosing copies of the two press releases dated May 7, 2004, and August 26, 2005, that the
Agency issued concerning this application .
Thank you again for your continued interest in this matter . If we can be of further assistance,
please let us know .
Sincerely,
atrick Ronan
for Legislatio n
4 Enclosures
I
2256 RAYBURN BUILDIN G
PETER J . VISCLOSKY WASHINGTON, DC 20515-1401
1ST DISTRICT, INDIAN A ( 202) 225-246 1
COMMITTEE ON APPROPRIATIONS 701 EAST 83RD AVENUE, SUITE 9
(Congress of t 4r Ull nitrb 9tates

SUBCOMMITTEES : MERRILLVILLE. I NN 4841 0
( 219) 795-184 4
DEFENS E
ENERGY AND WATER DEVELOPMENT Call Toll Free
i4 uus E of Rr~sr~es en ttttiues

1 888 423 PETE
CONGRESSIONAL STEEL CAUCUS
(1 888 423-7383 1
VICE-CHAIRMAN
INTERNET:
U .S. HOUSE LAW ENFORCEMENT
CAUCUS ® tts 4ing# on, :43C 2II515-140 1 http ://www .houx.povlvisclosky/
September 7, 200 5
The Honorable Lester Crawford

5600 Fishers Lan e
Dear Commissioner Crawford:
I write on behalf of several residents of Indiana's First Congressional District .
They have contacted me to express their concerns regarding the FDA's actions
concerning Plan B emergency contraception . Enclosed, please find a copy of the correspondence
I have received from them . I would appreciate your addressing their concerns and making their
correspondence part of the official comments you receive for the proposed regulation .
Thank you in advance for your serious consideration of this matter . Do not hesitate to let
me know if you have any questions or need additional information .
PJV :jd
Enclosures
THIS STATIONERY PRINTED ON PAPER MADE OF RECYCLED FIBERS

Gomez-Cruz, Blyth e
From : PJV
Sent : Wednesday, August 31, 2005 12 :33 AM
Subject : FW : WriteRep Response s
>
>----------
>From : Write your representative[SMTP :WRITEREP@HEOC-WWW 6 . ::0USE .GOV ]
>Sent : Wednesday, August 31, 2005 12 :33 :08 AM
>To : PJ V
>
DATE : August 31 , 2005 00 :23 AM
NAME :
ADDR1 :
ADDR2 :
ADDR3 :
CITY :
STATE :
ZIP :
PHONE :
EMAIL :
ms a :

U .S . House of Representatives
2256 Rayburn House Office Buildin g
to in•sestigate this decision .
women deserve a chance to prevent it . Increased access to Plan B emergency contraception
will also help to reduce the need for abortion . Plan B emergency contraception is safe,
Sincerely,
1
Gomez-C ruz, BIVth e
From : PJV
Sent : Wednesday, August 31, 2005 4 :32 PM
>
>----------
>From : Write your representative ( SMTP :WRITEREP@HEOC-WWW'o .HOUSE :GOV)
>Sent : Wednesday, August 31, 2005 4 :32 :11 P M
>To : PJ V
>
DATE : August ~31, 200 5 4 :23 P M
NAME :
ADDR1 :
ADDR2 :
ADDR3 :
CITY :
STATE' :
ZIP :
PHONE :
EMAIL :
msg :

22 5 6 Rayburn House Office Buildin g
0 Washington, DC 20515-000 1
Sincerely,
1
-S .
G omez-Cruz, Blyth e
From : PJ V
I Sent : Wednesday, August 31, 2005 9 :02 AM

>
>----------
>From : Write your representative[SMTP :WRITEREP@HEOC-WWW6 .HOUSE .GOV)
>Tc : PJ V
>
DATE :
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a Washington, DC 20515-000 1
Dear Representative Visclosky,
Sincerely,
1
Gomez-Cruz, B lyth e
From : PJ V
~ Sent : Wednesday, August 31, 2005 2 :02 PM
Subject : FW: WriteRep Response s
>
>----------
>From : Write your representati N7 e[SMTP :WRITEREP@'r.EOC-WWW6 .HOUSE .GOV]
>Sent : Wednesday, August 31, 2005 2 :02 :18 P M
>To : PJ V
>Autc forwarded by a Rul e
>
DATE : August 2005 1 :58 PM
P2
NAME :
ADDR1 :
ADDR2 :
ADDR3 :
CITY :
STATE :
ZIP :
PHONE :
EMAIL :
_nsg :

D 2256 Rayburn House Office Buildin g

it works . Women in this country deserve the same access that women in 38 other countrie s
.. -.
__e__, ~ ~. . _ _ .
around the world already enjoy . Millions of women, including survi_v
.or_
~ s
of, 'r-'a p ., stand _
Sincerely ,
1
From : PJ V
~ Sent : Wednesday, August 31, 2005 9 :32 AM
Subject : FW : WriteRep Responses
>
>----------
>From : Write your representative(SMTPiF]RITEREP@HEOC-WWW6 .HOUSE .GOVJ
>To : PJ V
>
DATE : a ugust 31, 2QO,~t _ Q,0LLJ,5 AM
NAME :
ADDR 1
ADDR2 :
ADDR3 . ~
CITY :
STATE :
ZIP :
PHONE :
EMAIL :
msg :

0 Washington, DC 20515-000 1
effective, and easy to use . But time is of the essence . The sooner it's taken,' the better
Sincerely,
From : PJ V
~ Sent : Wednesday, August 31, 2005 9 :02 AM
>
>----------
>From : Write your representative[SMTP :WRITEREP@HEOC-FW~1 6 .H0USE .GOV]
>To : PJV
>Subjec -: : WriteRep Responses
>
DATE : A~lgust 31, 2005 08 :51 AM
NAME :
ADDR1 :
ADDR2 :.
ADDR3 :
CITY :
STATE :
ZIP :
PHONE :
EMAIL :
msg :

around the world already enjoy . Millions of women, including survivors of rape, stan _ .d
Sincerely,
1
View f:lemailobj120050911191124700 .txt Page 1 of 2
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No From : Write your representative <writerep@heoc-www6 .house .gov >

Date : 9/1/2005 12 :31 :30 P M
To : IN01 IMA@mail .house.gov
Subject : WriteRep Response s
Representative Pete Visciosky

I am writing to voice my concern about the FDA's failure to rule

on the application to make Plan B emergency contraception (EC)
available over the counter . This decision is a major publi c
health setback for American women . We cannot allow anti-choice
ideology to corrupt science . Please speak out against the
government's willingness to sacrifice the health and lives of
women to promote a narrow ideological agenda . Call now for a
hearing to investigate this decision .
Unintended pregnancy is a significant public health problem in

the United States, and women deserve a chance to prevent it.
Increased access to Plan B emergency contraception will also
help to reduce the need for abortion . Plan ,B emergency
~ contraception is safe, effective, and easy to use . But time is
of the essence . The sooner it's taken, the better it works .
Women in this country deserve the same access that women in 38
other countries around the world already enjoy . Millions o f
women, including survivors of rape, stand ready to benefit from
this opportunity .
Sincerely ,
==== Original Formatted Message Starts Here === =
DATE : S e
NAM
ADD R
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msg :
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hftp ://in0l :800/tc asp/view _webmail .asp?object_id=f%3A%o5Cemailobj%o5C200 : . . 09%06%2005
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View f :\emailobj1200509\1\9193008 .tzf
From : Write your representative <write rep@heoc-www6 . house . gov>

Date : 8/31/2005 11 :01 :40 P M
To : IN01 IMA@mail .house .gov
Subject : WriteRep Responses

Washington ; DC 20515-000 1
Dear Representative Visciosky ,


the United States, and women deserve a chance to prevent it .
help to reduce the need for abortion . Plan B emergency
contraception is safe, effective, and easy to use . But time is
this opportunity .
Sincerely ,
==== Original Formatted Message Sta rt s Here === =
DATEAQgW31, 2Q45 10:.44 PM

NAM
ADDITT ree
ADDR2 :
ADD R
CITY :
ST.
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msg :
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hftp ://in0l :800/tc asp/view _webmail .asp?object_id=f%3A%o5Cemailohj%5C200 . 0970612005
View f:\emailobj\200509\1\91223534b .txt Page 1 of 2
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111 From : Write your representative <writerep@heoc-www6 . house . gov>

Date : 9/1/2005 10 :31 :56 P M
To : I N 01 IMA@mail .house .gov
Subject : WriteRep Response s


hearing to investigate this decision . '

this opportunity .
Sincerely ,
==== Original Forma tt ed Message Start s Here
DATE: ~gpt p mbgr 1 „29,Q5 1 Q2WM

NAME :
ADDRI : 1
ADDR2 :
ADDR3 :
CITY :
STAT
ZIP :
PHO N
EMA
msg :
http ://in01 :800/tc_asp/view_webmaii .asp?object_id=f%3A%o5Cemailobj%5C200 . . : 09/06/2005

E~-Mail Viewe r
#11 7305788 - Ms . Margaret L . Willis, In ID : 2344312, Out ID : 2484567 .
From : Write your representative <writerep@heoc-

www6 . house . gov >
Date : 9/1/2005 8 :31 :44 PM
Subject :WriteRep Response s



of the essence . The sooner it's taken, the better it works ._
a other countries around the world already enjoy . Millions o f
this opportunity .
Sincerely ,
==== Original Formatted Message Starts Here
DATE : Septernber 1, 2005 8 :19 PM

NA
ADD F
ADDR2 :
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CITY'
STAT
ZIP : 4
PHO O
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msg :
~Reprsntaiv Visclosky
Pete
http ://in01 :800/tc asp/ima text_popup_v2 .asp?xxx=53739 :15&oid=2484567&ro . . . 09/06/2005

, E;-Mail Viewe r Page 1 of 2
#17 189994 - Ms . MaryAnn Thompson, in ID : 2344337 ; Out ID: 2484625
From : Write your representative <writerep@heoc-

0 www6 . house . gov>
Date : 9/2/2005 1 :01 :55 PM
Subject :WriteRep Response s


on the application to make Plan B emergency contraception (EC )
health setback for American women, We cannot allow anti-choice

this opportunity .
Sincerely ,
==== Original Formatted Message Starts Here === =
DATE: Septem
NAME;
ADD I
ADDR2 :
ADDR3 :
CITY :
STAT
ZI P i
PHO
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msg :

http :/Iin01 :800/tc asp/ima text popup_v2 .asp?xxx=53965 :01 &oid=2484625&ro . . . 09/06/2005

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration

. The Honorable Linda T . Sanchez

DEPARTMENT OF HEALTH & HUMAN SERVICES

. The Honorable Albert R . Wynn

Dear Mr. Wynn :

Food and Drug Administration

• The Honorable William J . Jefferson

Dear Mr. Jefferson :

DEPARTMENT OF HEALTH & HUMAN SERVICES

• The Honorable Jim McDermott

DEPARTMENT OF HEALTH & HUMAN SERVICES

Md+re3a Food and Drug Administration

, The Honorable James P . Moran

DEPARTMENT OF HEALTH & HUMAN SERVICES

. The Honorable Jerrold Nadler

Dear Mr. Nadler:

DEPARTMENT OF HEALTH & HUMAN SERVICES

. The Honorable Donald M . Payne

. The Honorable Carolyn B . Maloney

Food and Drug Administration

. The Honorable Julia Carson

DEPARTMENT OF HEALTH & . HUMAN SERVICES

Food and Drug Administration

. The Honorable Danny K . Davis

Dear Mr. Davis :

DEPARTMENT OF HEALTH & HUMAN SERVICES

Dear Mr. Carnahan :

DEPARTMENT OF HEALTH & HUMAN SERVICES

. The Honorable Steve Israel

Dear Mr. Israel :

This is in response to your letter dated July 13, 2006, co-signed

'United ~5tates *nate FOREIGN RELATION S

June 15, 2006

I am contacting you on behalf of my constituent, Ms . x

cc : The Honorable Mel Martinez

(202) 224-3041 1/4*1~ BANKING

'United *aten .16enate '60's'. FOREIGN RELATION S

WASHINGTON, DC 20510-0 906 ~~6+

June 12, 2006

Mr. Amit Sachde v

I am contacting you on behalf of my constituent, M~~~~

M4Ws concerned about over-the-counter approval of "Plan B" emergency

' Tracking # 171735-D C

Web Mail Subject : FDA - Plan B

InterTrac Tracksheet 01 1 06/12/2006

Food and Drug Administration

cc : The Honorable Mel Martinez

DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

Food and Drug Administration

The Honorable Louise M . Slaughter

The Honorable Rob . Si.. . .mmons .

without the professional supervision of a licensed practitioner, and 2) an amended proposal

DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

The Honorable Judy Biggert

Page 2 - The Honorable Judy Biggert

without the professional supervision of a licensed practitioner, and 2) an amended proposal

Although I have concerns about wider availability of Plan B, I am deeply disappointed

I look forward to receiving your responses to these important questions .

cc : Secretary Michael 0 . Leavitt

if PETER J . VISCLOSK Y 2256 RAYBURN BUILDING

Tung rP as of t4je ~ni#rb § # a#P~

U .S . HOUSE LAW ENFORCEMENT INTERNET:

The Honorable Lester Crawford