You're viewing Docket Item 57 from the case Tummino v. Hamburg. View the full docket and case details.

Download this document:




Case: 13-1690 Document: 57-2 Page: 1 05/20/2013 943308 98

No. 13-1690

IN THE UNITED STATES COURT OF APPEALS

FOR THE SECOND CIRCUIT

ANNIE TUMMINO, et al.,

Plaintiffs-Appellees,

v.

MARGARET HAMBURG, Commissioner of Food and Drugs, et al.,

Defendants-Appellants

ON APPEAL FROM THE UNITED STATES DISTRICT COURT

FOR THE EASTERN DISTRICT OF NEW YORK

PLAINTIFFS-APPELLEES’ ADDENDUM TO OPPOSITION
TO DEFENDANTS-APPELLANTS’ MOTION FOR A STAY

PENDING APPEAL

JANET CREPPS
Center for Reproductive Rights
120 Wall Street, 14th Floor
New York, NY 10005

ANDREA COSTELLO
MARA VERHEYDEN-HILLIARD
Partnership for Civil Justice Fund
617 Florida Avenue, NW
Washington, D.C. 20001

KIRSTEN CLANTON

Southern Legal Counsel, Inc.
1229 NW 12th Ave.
Gainesville, FL 32601

Case: 13-1690 Document: 57-2 Page: 2 05/20/2013 943308 98

ADDENDUM TABLE OF CONTENTS

Statutes

Page

Tummino v. Torti, 603 F.Supp.2d 519 (Mar. 23, 2009) (“Tummino I”)……….. Pls-Add-1

Order Amending Tummino I (Mar. 6, 2013)………………………………. Pls-Add-31

Letter from Frank Amanat to Suzanne Novak (Aug. 13, 2010)…………... Pls-Add-33

Statement by Margaret Hamburg (Dec. 11, 2011)………………………... Pls-Add-36

Letter and Statement by Kathleen Sebelius (Dec. 11, 2011)……………… Pls-Add-37

Letter from Scott Landau to Judge Korman (Dec. 12, 2011)……………... Pls-Add-40

Letter from Janet Woodcock to Bonnie Scott Jones (Dec. 12, 2011)……... Pls-Add-41

Declaration of Mary K. Pendergast (Feb. 7, 2012)……………………….. Pls-Add-51

Declaration of Cynthia Harper, Ph.D. (Feb. 3, 2012)…………………….. Pls-Add-69

Case: 13-1690 Document: 57-2 Page: 3 05/20/2013 943308 98

603 F.Supp.2d 519
(Cite as: 603 F.Supp.2d 519)

United States District Court,

E.D. New York.

Annie TUMMINO et al., Plaintiffs,

v.

Frank M. TORTI,FN* Acting Commissioner of the

Food and Drug Administration, Defendant.

FN* Pursuant to Federal Rule of Civil Pro-
cedure 25(d), Acting Commissioner Frank
M. Torti has been substituted for former
Commissioner Andrew C. von Eschenbach
as defendant in this case. Earlier in this liti-
gation, Commissioner von Eschenbach was
substituted for former Commissioner Lester
M. Crawford, the original named defendant.

No. 05-CV-366 (ERK)(VVP).

March 23, 2009.

Background: Challenge was brought against Food
and Drug Administration's (FDA) denial of citizen
petition that sought nonprescription availability for
women of all ages of “Plan B” synthetic hor-
mone-based emergency contraceptive.

Holdings: The District Court, Korman, J., held that:
(1) adolescent girls who challenged denial of citizen
petition satisfied injury-in-fact criterion for constitu-
tional standing;
(2) girls also satisfied prudential standing;
(3) District Court in reviewing denial of citizen peti-
tion could consider administrative record for related
supplemental new drug applications (SNDAs);
(4) sufficient evidence supported finding that im-
proper political influence had borne upon denial of
citizen petition;
(5) FDA's departures from normal procedures also

Page 1

weighed in favor of finding of bad faith; and
(6) remand was appropriate remedy except as to
17-year-olds, for whom contraceptive's safe use was
conceded.

Vacated and remanded.

West Headnotes

[1] Health 198H

323

198H Health

198HI Regulation in General

198HI(E) Drugs; Medical Devices and In-

struments

198Hk323 k. Judicial Review or Interven-

tion. Most Cited Cases

Food and Drug Administration's (FDA) denial of
citizen petition seeking approval of switch from pre-
scription to over-the-counter (OTC) status for partic-
ular drug was reviewable by federal district court, i.e.
was not allocated to Court of Appeals in first instance.
Federal Food, Drug, and Cosmetic Act, § 503(b)(3),
21 U.S.C.A. § 353(b)(3); 21 C.F.R. §§ 10.25(a),
10.45(g).

[2] Federal Civil Procedure 170A

103.5

170A Federal Civil Procedure

170AII Parties

170AII(A) In General

170Ak103.1 Standing

170Ak103.5 k. Pleading. Most Cited

Cases

On motion to dismiss for lack of standing, alle-
gations in complaint must be accepted as true for
purposes of standing.

© 2013 Thomson Reuters. No Claim to Orig. US Gov. Works.

Pls-Add-1Case: 13-1690 Document: 57-2 Page: 4 05/20/2013 943308 98

Page 2

603 F.Supp.2d 519
(Cite as: 603 F.Supp.2d 519)

[3] Federal Civil Procedure 170A

103.2

170A Federal Civil Procedure

170AII Parties

170AII(A) In General

170Ak103.1 Standing

170Ak103.2 k. In General; Injury or

Interest. Most Cited Cases

Federal Civil Procedure 170A

103.3

[5] Federal Civil Procedure 170A

103.2

170A Federal Civil Procedure

170AII Parties

170AII(A) In General

170Ak103.1 Standing

170Ak103.2 k. In General; Injury or

Interest. Most Cited Cases

Plaintiff bears the burden of establishing each
element of constitutional standing. U.S.C.A. Const.
Art. 3, § 2, cl. 1.

170A Federal Civil Procedure

170AII Parties

170AII(A) In General

170Ak103.1 Standing

[6] Health 198H

323

198H Health

170Ak103.3 k. Causation; Redressabil-

198HI Regulation in General

ity. Most Cited Cases

198HI(E) Drugs; Medical Devices and In-

Constitutional standing requires plaintiff to show:
(1) injury in fact; (2) which is fairly traceable to de-
fendant's conduct; and (3) which is likely to be re-
dressed by requested relief. U.S.C.A. Const. Art. 3, §
2, cl. 1.

[4] Federal Civil Procedure 170A

103.2

170A Federal Civil Procedure

170AII Parties

170AII(A) In General

170Ak103.1 Standing

170Ak103.2 k. In General; Injury or

Interest. Most Cited Cases

“Injury in fact,” for purposes of constitutional
standing requirements, is defined as invasion of le-
gally protected interest which is: (1) concrete and
particularized, and (2) actual or imminent, not con-
jectural or hypothetical. U.S.C.A. Const. Art. 3, § 2,
cl. 1.

struments

198Hk323 k. Judicial Review or Interven-

tion. Most Cited Cases

Adolescent girls satisfied injury-in-fact criterion
for constitutional standing in their challenge to Food
and Drug Administration's (FDA) denial of nonpre-
scription availability for women of all ages of “Plan
B” emergency contraceptive; delay occasioned by
having to obtain prescription prior to purchasing con-
traceptive could increase chance of unwanted preg-
nancy, given its effectiveness duration of 72 hours,
and parents' obtaining Plan B on behalf of their
daughters absent prescription for daughters' use would
violate FDCA. U.S.C.A. Const. Art. 3, § 2, cl. 1;
Federal Food, Drug, and Cosmetic Act, §§ 301(k),
303(a)(1), 503(b)(3), 21 U.S.C.A. §§ 331(k),
333(a)(1), 353(b)(3); 21 C.F.R. § 10.25(a).

[7] Health 198H

323

198H Health

198HI Regulation in General

198HI(E) Drugs; Medical Devices and In-

© 2013 Thomson Reuters. No Claim to Orig. US Gov. Works.

Pls-Add-2Case: 13-1690 Document: 57-2 Page: 5 05/20/2013 943308 98

Page 3

603 F.Supp.2d 519
(Cite as: 603 F.Supp.2d 519)

struments

struments

198Hk323 k. Judicial Review or Interven-

198Hk323 k. Judicial Review or Interven-

tion. Most Cited Cases

tion. Most Cited Cases

Advocacy organization and its members satisfied
injury-in-fact criterion for constitutional standing in
their challenge to Food and Drug Administration's
(FDA) point-of-sale restriction on availability of “Plan
B” emergency contraceptive, which required that
contraceptive be kept behind pharmacy counter; bur-
den imposed by restriction might delay woman's abil-
ity to obtain Plan B quickly, and thereby reduce its
efficacy. U.S.C.A. Const. Art. 3, § 2, cl. 1; Federal
Food, Drug, and Cosmetic Act, § 503(b)(3), 21
U.S.C.A. § 353(b)(3); 21 C.F.R. § 10.25(a).

[8] Health 198H

323

198H Health

198HI Regulation in General

On challenge against Food and Drug Admin-
istration's (FDA) denial of citizen petition that sought
over-the-counter (OTC) availability for women of all
ages of “Plan B” emergency contraceptive, federal
district court was not limited to consideration of ad-
ministrative record compiled for petition alone, but
could also consider administrative record for sup-
plemental new drug applications (SNDAs) submitted
by drug's sponsor; SNDA materials were before FDA
when it acted on citizen petition, and issues presented
by citizen petition and SNDAs were identical. Federal
Food, Drug, and Cosmetic Act, § 503(b)(3), 21
U.S.C.A. § 353(b)(3); 21 C.F.R. § 10.25(a).

[10] Administrative Law and Procedure 15A

314

198HI(E) Drugs; Medical Devices and In-

struments

15A Administrative Law and Procedure

198Hk323 k. Judicial Review or Interven-

15AIV Powers and Proceedings of Administrative

tion. Most Cited Cases

Adolescent girls satisfied prudential standing in
their challenge to Food and Drug Administration's
(FDA) denial of nonprescription availability for
women of all ages of “Plan B” emergency contracep-
tive; girls were within zone of interests of FDCA since
they were among class of individuals whom FDCA
was intended to protect by providing non-prescription
access to a drug when prescription would be burden-
some and unnecessary. Federal Food, Drug, and
Cosmetic Act, § 503(b)(1, 3), 21 U.S.C.A. § 353(b)(1,
3); 21 C.F.R. § 10.25(a).

Agencies, Officers and Agents

15AIV(A) In General

15Ak314 k. Bias, Prejudice or Other Dis-

qualification to Exercise Powers. Most Cited Cases

To support claim of improper political influence
on federal administrative agency, warranting finding
of bad faith and consequent abuse of discretion under
Administrative Procedure Act (APA), there must be
some showing that political pressure was intended to
and did cause agency's action to be influenced by
factors not relevant under controlling statute. 5
U.S.C.A. § 706(2)(A).

[9] Health 198H

323

[11] Administrative Law and Procedure 15A

314

198H Health

198HI Regulation in General

15A Administrative Law and Procedure

198HI(E) Drugs; Medical Devices and In-

15AIV Powers and Proceedings of Administrative

© 2013 Thomson Reuters. No Claim to Orig. US Gov. Works.

Pls-Add-3Case: 13-1690 Document: 57-2 Page: 6 05/20/2013 943308 98

Page 4

603 F.Supp.2d 519
(Cite as: 603 F.Supp.2d 519)

Agencies, Officers and Agents

15AIV(A) In General

struments

198Hk305 k. Prescription Requirement;

15Ak314 k. Bias, Prejudice or Other Dis-

Ethical Drugs. Most Cited Cases

qualification to Exercise Powers. Most Cited Cases

In event of improper political influence on federal
administrative agency, agency's consideration of some
relevant factors does not “immunize” agency's deci-
sion, i.e. does not preclude finding of bad faith and
consequent abuse of discretion under Administrative
Procedure Act (APA). 5 U.S.C.A § 706(2)(A).

[12] Health 198H

305

198H Health

198HI Regulation in General

198HI(E) Drugs; Medical Devices and In-

struments

198Hk305 k. Prescription Requirement;

Ethical Drugs. Most Cited Cases

Sufficient evidence supported finding that im-
proper political influence had borne upon Food and
Drug Administration's (FDA) denial of citizen petition
seeking over-the-counter (OTC) availability for
women of all ages of “Plan B” emergency contracep-
tive, as required to support determination of bad faith
and abuse of discretion by FDA; denial went against
recommendations of FDA's advisory committee and
its scientific review staff, there was evidence of White
House pressure upon FDA commissioner, and deci-
sion to permit OTC sales to women over 18 appeared
timed to facilitate commissioner's confirmation. 5
U.S.C.A. § 706(2)(A); Federal Food, Drug, and
Cosmetic Act, § 503(b)(3), 21 U.S.C.A. § 353(b)(3);
21 C.F.R. § 10.25(a).

[13] Health 198H

305

198H Health

198HI Regulation in General

198HI(E) Drugs; Medical Devices and In-

citizen petition

Food and Drug Administration's (FDA) depar-
tures from normal procedures weighed in favor of
finding of bad faith, and abuse of discretion, in
agency's denial of
seeking
over-the-counter (OTC) availability for women of all
ages of “Plan B” emergency contraceptive; agency
departed by acting against its advisory committee's
recommendation, by placing additional members on
advisory committee to achieve ideological balance, by
apparently making decision before scientific reviews
were complete, and by refusing to extrapolate actu-
al-use study data
to
16-and-under group. 5 U.S.C.A. § 706(2)(A); Federal
Food, Drug, and Cosmetic Act, § 503(b)(1, 3), 21
U.S.C.A. § 353(b)(1, 3); 21 C.F.R. § 10.25(a).

from older age group

[14] Health 198H

323

198H Health

198HI Regulation in General

198HI(E) Drugs; Medical Devices and In-

struments

198Hk323 k. Judicial Review or Interven-

tion. Most Cited Cases

On district court's finding that Food and Drug
Administration (FDA) had acted in bad faith and
abused its discretion by denying citizen petition
seeking over-the-counter (OTC) availability for
women of all ages of “Plan B” emergency contracep-
tive, remand to FDA was appropriate remedy, except
as to 17-year-olds for whom drug's safe use was con-
ceded; agency had new commissioner, so that remand
was not necessarily futile, and district court was in no
position
synthetic hor-
mone-based drug was safe without prescription for
girls of very young ages. Federal Food, Drug, and
Cosmetic Act, § 503(b)(3), 21 U.S.C.A. § 353(b)(3);

to determine whether

© 2013 Thomson Reuters. No Claim to Orig. US Gov. Works.

Pls-Add-4Case: 13-1690 Document: 57-2 Page: 7 05/20/2013 943308 98

Page 5

603 F.Supp.2d 519
(Cite as: 603 F.Supp.2d 519)

21 C.F.R. § 10.25(a).

*522 Andrea H. Costello, Newberry, FL, Suzanne
Ilene Novak, Janet Crepps, Sanford Cohen, Bonnie
Scott Jones, New York, NY, Natalie N. Maxwell,
Southern Legal Counsel, Inc., Gainesville, FL, for
Plaintiffs.

F. Franklin Amanat, United States Attorneys Office,
Eastern District of New York, Brooklyn, NY, for
Defendant.

MEMORANDUM & ORDER

KORMAN, District Judge:

Plan B is an emergency contraceptive that can be
used to reduce the risk of unwanted pregnancy after
sexual intercourse. When used as directed, it can re-
duce the risk of pregnancy by up to 89 percent. Plan B
acts mainly by stopping the release of an egg from an
ovary. It may also prevent sperm from fertilizing an
egg that has been released or, if fertilization has al-
ready occurred, block implantation of the resulting
embryo in the uterus. Plan B does not have any known
serious or long-term side effects, though it may have
some mild and short-term side effects, such as nausea
or abdominal pain, in some users. The approved
dosage of Plan B is two pills taken 12 hours apart,
each containing 0.75 mg of levonorgestrel, a synthetic
hormone similar to the naturally occurring hormone
progesterone. Because the drug works best when taken
within 24 hours of sexual intercourse, it is commonly
referred to as a “morning-after pill.” Nevertheless, the
drug is effective if the first dose is taken within 72
hours of sexual intercourse. Studies have shown that
Plan B is equally effective if the two doses of levo-
norgestrel are taken less than 12 hours apart or at the
same time.

Plan B was approved for prescription-only use in
the United States in 1999 and is the only emergency
contraceptive drug currently available in the United
States. Plan B and other emergency contraceptives

with the same active ingredient are available without a
prescription or age restriction in much of the world,
including virtually all major industrialized nations.
Plaintiffs-individuals and organizations advocating
wider distribution of and access to emergency con-
traceptives, as well as parents and their minor children
seeking access to the same-brought this action chal-
lenging the denial of a Citizen Petition, *523 which
requested that the Food and Drug Administration
(“FDA”) make Plan B available without a prescription
to women of all ages.

new

drug

The FDA considered the Citizen Petition in tan-
dem with a number of proposals-referred to as sup-
plemental
applications
(“SNDA”)-submitted by Women's Capital Corpora-
tion, the drug's original manufacturer. Women's Cap-
ital Corporation sold its right to market Plan B to Barr
Pharmaceuticals, Inc. during the course of the pro-
ceedings described below. I refer to them collectively
as the “Plan B sponsor.” The first SNDA, like the
Citizen Petition, sought non-prescription access to
Plan B for women of all ages. After the FDA denied
such access, the Plan B sponsor submitted a second
SNDA, seeking non-prescription access for women 16
and older. The FDA rejected that application too de-
spite nearly uniform agreement among FDA scientific
review staff that women of all ages could use Plan B
without a prescription safely and effectively. The Plan
B sponsor then submitted a third SNDA, which pro-
posed making Plan B available without a prescription
to women 17 and older. While FDA scientists and
senior officials found that 17 year olds could use Plan
B safely without a prescription, the FDA Commis-
sioner determined that, because of “enforcement”
concerns, Plan B would be available without a pre-
scription only to women 18 and older. Putting aside
for the moment the specifics of the many claims
brought by plaintiffs and the details of each of the
FDA's decisions, the gravamen of plaintiffs' claims is
that the FDA's decisions regarding Plan B-on the
Citizen Petition and the SNDAs-were arbitrary and
capricious because they were not the result of rea-

© 2013 Thomson Reuters. No Claim to Orig. US Gov. Works.

Pls-Add-5Case: 13-1690 Document: 57-2 Page: 8 05/20/2013 943308 98

Page 6

603 F.Supp.2d 519
(Cite as: 603 F.Supp.2d 519)

soned and good faith agency decision-making.

the

involved

Plaintiffs are right. The FDA repeatedly and un-
reasonably delayed issuing a decision on Plan B for
suspect reasons and, on two occasions, only took
action on Plan B to facilitate confirmation of Acting
FDA Commissioners, whose confirmation hearings
had been held up due to these repeated delays. The
first occasion
confirmation of
then-Acting FDA Commissioner Lester M. Crawford,
who froze the review process for seven months in
2005. In order to overcome a hold that had been placed
on his nomination by two Senators, the Secretary of
Health and Human Services promised that the FDA
would act on Plan B by September 2005. After Dr.
Crawford was confirmed by the Senate in July 2005,
however, he reneged on the promise and, instead,
delayed action another eleven months to pursue, and
then abandon, a rulemaking with respect to Plan B.
There is also evidence that when the FDA finally
decided to approve non-prescription use of Plan B for
women 18 and older, it did so to facilitate the con-
firmation of Commissioner Crawford's successor,
then-Acting FDA Commissioner Andrew C. von
Eschenbach, whose confirmation certain Senators had
vowed to block because of the continued delays on
Plan B.

These political considerations, delays, and im-
plausible justifications for decision-making are not the
only evidence of a lack of good faith and reasoned
agency decision-making. Indeed, the record is clear
that the FDA's course of conduct regarding Plan B
departed in significant ways from the agency's normal
procedures regarding similar applications to switch a
drug product from prescription to non-prescription
use, referred to as a “switch application” or an
“over-the-counter switch.” For example, FDA upper
management, including the Commissioner, wrested
control over the decision-making on Plan B from staff
that normally would issue the final decision on an
over-the-counter switch application; the FDA's deni-
al*524 of non-prescription access without age re-

striction went against the recommendation of a com-
mittee of experts it had empanelled to advise it on Plan
B; and the Commissioner-at the behest of political
actors-decided to deny non-prescription access to
women 16 and younger before FDA scientific review
staff had completed their reviews.

In light of this evidence, the FDA's denial of the
Citizen Petition is vacated and the matter is remanded
to the FDA for reconsideration of whether to approve
Plan B for over-the-counter status without age or
point-of-sale restrictions. While the FDA is free, on
remand, to exercise its expertise and discretion re-
garding the proper disposition of the Citizen Petition,
no useful purpose would be served by continuing to
deprive 17 year olds access to Plan B without a pre-
scription. Indeed, the record shows that FDA officials
and staff both agreed that 17 years olds can use Plan B
safely without a prescription. The FDA's justification
for this age restriction, that pharmacists would be
unable to enforce the prescription requirement if the
cutoff were age 17, rather than 18, lacks all credibility.

I now proceed to outline the statutory and regu-
latory framework for the FDA's consideration of
over-the-counter switch applications in general, detail
the FDA's evaluations of and decisions regarding Plan
B, and recount the procedural history of this action. I
then turn to the merits of plaintiffs' claim that the
FDA's denial of the Citizen Petition was arbitrary and
capricious.

I. Background

A. Statutory and Regulatory Background

Under the Federal Food, Drug, and Cosmetic Act
(“FDCA”), 21 U.S.C. §§ 301 et seq., no new drug
product may be sold in the United States unless the
Secretary of Health and Human Services (“Secretary”)
first approves a new drug application (“NDA”) sub-
mitted by the drug's sponsor. Id. § 355. The Secretary
delegated primary responsibility over drug regulation
to the Commissioner of the FDA (“Commissioner”).
Id. § 393(d). As part of the NDA, the drug sponsor

© 2013 Thomson Reuters. No Claim to Orig. US Gov. Works.

Pls-Add-6Case: 13-1690 Document: 57-2 Page: 9 05/20/2013 943308 98

Page 7

603 F.Supp.2d 519
(Cite as: 603 F.Supp.2d 519)

must submit, inter alia, “full reports of investigations
which have been made to show whether or not such
drug is safe for use and whether such drug is effective
in use” to the FDA. Id. § 355(b)(1)(A). An NDA will
be denied if “the investigations ... do not include ad-
equate tests by all methods reasonably applicable to
show whether or not such drug is safe for use under the
conditions prescribed, recommended, or suggested in
the proposed labeling thereof,” “the results of such
tests show that such drug is unsafe for use under such
conditions or do not show that such drug is safe for use
under such conditions,” or there is “insufficient in-
formation to determine whether such drug is safe for
use under such conditions.” Id. §§ 355(d)(1), (2), (4).

A drug must be dispensed by prescription if,
“because of its toxicity or other potentiality for
harmful effect, or the method of its use, or the collat-
eral measures necessary to its use, [it] is not safe for
use except under the supervision of a practitioner
licensed by law to administer such drug.” Id. §
353(b)(1)(A). A drug may be moved from prescrip-
tion-only to non-prescription status when the Secre-
tary deems that the prescription requirement is not
necessary for the protection of the public health. Id. §
353(b)(3). Specifically, the applicable regulation
provides that:

Any drug limited to prescription use ... shall be
exempted from prescription-dispensing require-
ments when the Commissioner finds such require-
ments are not necessary for the protection of the
public health by reason of the drug's toxicity or
other potentiality for harmful *525 effect, or the
method of its use, or the collateral measures nec-
essary to its use, and he finds that the drug is safe
and effective for use in self-medication as directed
in proposed labeling.

21 C.F.R. § 310.200(b). Many new drugs are ini-
tially approved for prescription-only status and then
later considered for non-prescription status, i.e., an
over-the-counter or OTC switch. A drug is suitable for

OTC use when found to be safe and effective for
self-administration and when its labeling clearly pro-
vides directions for safe use and warnings regarding
unsafe use, side effects, and adverse reactions. See id.
§ 330.10(a)(4). These regulations were promulgated
following the adoption of the Durham-Humphrey
Amendment to the FDCA in 1951. The amendment
was intended, in part, “to relieve retail pharmacists
and the public from burdensome and unnecessary
restrictions on the dispensing of drugs that are safe for
use without the supervision of a physician.” S.Rep.
No. 82-946 (1951), as reprinted in 1951 U.S.C.C.A.N.
2454, 2454; H.R.Rep. No. 82-700 at 2454 (1951).

There are two means by which the FDA can
switch a prescription-only drug to non-prescription
status. First, it can promulgate a regulation changing
the drug's status. See 21 U.S.C. § 353(b)(3). This
rulemaking process may be initiated by the Commis-
sioner, 21 C.F.R. § 310.200(b), or by any interested
person who files a citizen petition. Id. § 10.25(a).
Within 180 days of receipt of the petition, the Com-
missioner must either approve or deny the petition or
provide “a tentative response [to the petitioner], in-
dicating why the agency has been unable to reach a
decision on the petition.” Id. § 10.30(e)(2)(iii). Al-
ternatively, a drug
request an
over-the-counter switch. Id. § 310.200(b). Unlike the
first mechanism, this process does not require rule-
making. See 21 U.S.C. §§ 355(c), (d); 21 C.F.R. §
314.71. Nevertheless, only the drug sponsor can sup-
plement its initial new drug application. 21 C.F.R. §
314.71(a). All of the rules and procedures applicable
to new drug applications, discussed above, apply to
supplemental new drug applications (SNDAs). Id. §
314.71(c).

sponsor may

The Commissioner delegated authority over OTC
switch applications to the FDA's Center for Drug
Evaluation and Research (“CDER”). FDA Staff
Manual
1410.30(1),
1410.104(1). OTC switch applications are reviewed
by two offices within CDER: the Office of Drug

(“SMG”)

Guidelines

© 2013 Thomson Reuters. No Claim to Orig. US Gov. Works.

Pls-Add-7Case: 13-1690 Document: 57-2 Page: 10 05/20/2013 943308 98

Page 8

603 F.Supp.2d 519
(Cite as: 603 F.Supp.2d 519)

Evaluation (“ODE”) V, which reviews all OTC switch
applications, and, in this case, the ODE III, which
includes the Division of Reproductive and Urologic
Drug Products (“DRUDP”). CDER may seek scien-
tific advice from outside experts by empanelling an
advisory committee to provide a recommendation on
an application. After reviewing the OTC switch ap-
plication and the advice of the advisory committee, the
directors of the two ODEs make a decision. If the
Director of CDER disagrees with that decision, the
Director may change the decision. Pls.' Ex. B at 9
(General Accountability Office, Food and Drug Ad-
ministration: Decision Process to Deny Initial Ap-
plication for Over-the-Counter Marketing of the
Emergency Contraceptive Drug Plan B Was Unusual,
GAO Doc. No. GAO-06-109 (November 2005),
hereinafter “GAO Report”).

B. Factual Background

In February 1997, the FDA announced that cer-
tain combined oral contraceptives are safe and effec-
tive for emergency use, and requested sponsors to
submit new drug applications for that use. On July 28,
1999, the FDA approved an NDA for Plan B submit-
ted by the Plan B sponsor. Plan B then became
available to consumers in the United States on a pre-
scription-only basis.

*526 1. Filing of the Citizen Petition and First OTC
Switch Application

On February 14, 2001, one of the named plain-
tiffs, the Association of Reproductive Health Profes-
sionals (“ARHP”), and sixty-five other organizations
(together the “petitioners”) filed a Citizen Petition,
asking the FDA to switch Plan B, and all emergency
contraceptives like it, from prescription-only to
over-the-counter status without age or point-of-sale
restrictions. The petition included affidavits from Dr.
David Grimes, the chair of the World Health Organi-
zation task force that had conducted the largest and
most definitive trials on Plan B to date, and Dr. Eliz-
abeth Raymond, who conducted the label compre-
hension and actual use studies which the Plan B

sponsor would ultimately submit in support of its
SNDA. Numerous national organizations, including
the American Medical Association, the American
College of Obstetricians and Gynecologists, and the
American Public Health Association, endorsed the
petition. Def.'s Ex. 1 at CP020-28.

Upon receipt of the Citizen Petition in February
2001, the FDA noted that (1) “[t]he petition clearly
outlines how ... Plan B[ ] meet[s] all the criteria for
OTC availability,” (2) the statements in the petition
“are supported by scientific data and the cited litera-
ture,” and (3) “DRUDP [Division of Reproductive and
Urologic Drug Products] agrees with much of the
scientific information presented in the supporting
statements.” Def.'s Ex. 3 at T-30004. Nevertheless,
Dr. Andrea Leonard-Segal of the Division of the
Over-the-Counter Drug Products (“DOTCDP”), who
reviewed the Citizen Petition in April 2001, identified
a number of safety concerns which needed evaluation
through an actual use study. Id. at Tummino (“T”)
30023. Among these concerns were whether con-
sumers would use emergency contraception instead of
more effective forms of birth control, whether ado-
lescent girls could comprehend and use emergency
contraception, and whether the availability of emer-
gency contraception would dissuade consumers from
being tested for sexually transmitted diseases. Dr.
Segal noted that the sponsor of Plan B “expressed a
willingness to work with the Agency to address the[ ]
concerns” raised by the petition. Id.

On September 6, 2001, the FDA advised the pe-
titioners that it had not yet resolved the issues raised in
the Citizen Petition, but that it would respond “as soon
as we have reached a decision on your request.” Def.'s
Ex. 1 at CP029. The FDA did not respond for nearly
five more years, when it announced, on June 9, 2006,
that it had denied the petition. Id. at CP001-19. During
this period, however, the FDA communicated regu-
larly with the Plan B sponsor about its anticipated
SNDA. Indeed, in February 2001, shortly before the
Citizen Petition had been filed, FDA staff met with the

© 2013 Thomson Reuters. No Claim to Orig. US Gov. Works.

Pls-Add-8Case: 13-1690 Document: 57-2 Page: 11 05/20/2013 943308 98

Page 9

603 F.Supp.2d 519
(Cite as: 603 F.Supp.2d 519)

Plan B sponsor to discuss a development plan for an
over-the-counter switch application, including the
details for a proposed actual use study and label
comprehension study. Def.'s Ex. 3. at T-30005-17.
Specifically, the FDA made a number of recommen-
dations regarding the age composition of participants
in a proposed actual use study and the importance of
enrolling young adolescents. The sponsor indicated
that it would seek to enroll at least 50 participants aged
17 years of age or younger. Id. at T-30047. The FDA
did not disapprove of this figure or recommend a
larger number. See id. at T-30254. Indeed, in subse-
quent meetings prior to the filing of the SNDA, FDA
staff assured the sponsor that the actual use study, the
study the FDA considered “pivotal” to the application,
“appear[ed] to be adequate for filing.” Id. Moreover,
as early as April 2002, the FDA informed the Plan B
sponsor that results from trials in *527 the adult pop-
ulation could be extrapolated to the postmenarcheal
pediatric population. Pls.' Ex. F-1 at T-30100. The
Director of the Office of New Drugs (“OND”), Dr.
John K. Jenkins, noted that “the Agency has a long
history of extrapolating findings from clinical trials in
older patients to adolescents.” Pls.' Ex. A-3 at
T-30898.

On April 21, 2003, over two years after it had
begun discussions with the FDA, the Plan B sponsor
submitted an SNDA formally requesting that Plan B
be switched from prescription-only to OTC status
without age or point-of-sale restriction. On June 9,
2003, the FDA accepted the SNDA for review and set
a goal date of February 20, 2004 to render a decision
on the application. Def.'s Ex. 3 at T-30284.

2. Review of First OTC Switch Application: OTC
Access Without Age Restriction

As discussed above, while the Plan B sponsor did
not formally submit the SNDA until April 2003, the
FDA was aware of and anticipated the application well
in advance. Indeed, at an Office of the Commissioner's
meeting in June 2002, FDA officials-including then
Deputy Commissioner Dr. Lester Crawford-and re-

view staff discussed the “political sensitivity” of a
potential switch to OTC status for Plan B. Pls.' Ex.
A-1 at T-30167. These discussions regarding the po-
litical implications of the switch applications were not
limited to intra-agency meetings: On the very same
day that the Plan B sponsor first formally requested
OTC status, then-FDA Commissioner Dr. Mark
McClellan discussed the pending application with Jay
Lefkowitz, the Deputy Assistant to the President for
Domestic Policy at the White House. Id. at T-509.
Commissioner McClellan testified that he had pro-
vided several updates on the Plan B application to
relevant policy staff at the White House. Pls.' Ex. D-2
at McClellan Dep. 140:19-141:13.

Moreover, deposition testimony of several FDA
senior staff members reveals that political and ideo-
logical factors played a determinative role in the
nomination and selection process for membership on
the Advisory Committee for Reproductive Health
Drugs, which, along with the Advisory Committee for
the “Advisory
Non-prescription Drugs (together
Committee”), was empanelled by the FDA to make
recommendations as to how the FDA should respond
to the OTC switch applications. See 68 Fed. Reg.
66113 (Nov. 25, 2003).

The common procedure for selecting members of
such committees was for the offices and divisions
within CDER to “put together a panel of nominees and
send those up [to the Office of the Commissioner] for
clearance. [However, i]n this case names were sent
down.” Pls.' Ex. D-1 at Houn Dep. 30:16-18; Pls.' Ex.
D-2 at Kweder Dep. 37:16-20. According to Dr. Jen-
kins, “[i]t wasn't as if names were being floated for
internal vetting. These names were being sent down as
these are new people who will be on the Committee.”
Pls.' Ex. D-2 at Jenkins Dep. 258:12-15. The Deputy
Director of the Office of New Drugs (OND), Dr.
Sandra Kweder, who had been involved in the for-
mation of many advisory committees, id. at Kweder
Dep. 37:12-15, testified that the Office of the Com-
missioner appointed several individuals to the com-

© 2013 Thomson Reuters. No Claim to Orig. US Gov. Works.

Pls-Add-9Case: 13-1690 Document: 57-2 Page: 12 05/20/2013 943308 98

Page 10

603 F.Supp.2d 519
(Cite as: 603 F.Supp.2d 519)

mittee “who would [not] normally [be] considered as
the kind of people we would be looking for to be on
the panel.” Id. at 35:3-5. These people had “very lim-
ited experience in product development, clinical trials.
They were not well-published.” Id. at 35:8-10; Pls.'
Ex. D-1 at Houn Dep. 31:13-15, 39:13-40:4. Dr.
Florence Houn, Director of the ODE III, testified that
the individuals appointed by the Office of the Com-
missioner did not have “[e]xpertise recognized on a
regional or national level or specialty field *528 that
would help our deliberations.” Pls.' Ex. D-1 at Houn
Dep. 39:1-3.

The Office of the Commissioner appointed
members to the Advisory Committee not for their
expertise, but to achieve what the Office of the
Commissioner called a “balance of opinion” on the
panel. Pls.' Ex. D-2 at Kweder Dep. 30:2-22. Indeed,
Dr. Kweder testified that the Commissioner's office
rejected many qualified nominees proposed by CDER
in favor of individuals who shared a common ideo-
logical viewpoint. Id. at 30:4-21, 28:16-29:3. Specif-
ically, “the backgrounds of many of the candidates
that were forwarded [by the Commissioner's office] ...
had an ideological commonality.... They were ... peo-
ple who were very active in the Right to Life antia-
bortion world.” Id. at 37:4-6, 8-10. According to Dr.
Kweder, the CDER is “not ... looking for people who
have an opinion coming in [to their participation on
the committee]. That's exactly what we don't want. We
want people who can look at what's before them and
render an assessment and recommendation on the
basis of that.” Id. at 30:13-18.

In preparation for the Advisory Committee
meeting, which would consider whether to recom-
mend approval of the Plan B sponsor's switch appli-
cations, review staff met with and informed Commis-
sioner McClellan that “[t]he results of the AUS [actual
use study] demonstrated that the frequency of unpro-
tected sex did not increase, condom use did not de-
crease, and the overall use of effective contraception
did not decrease [with use of Plan B].” Def.'s Ex. 3 at

T-30394. Staff noted that while only 5 percent of
subjects recruited for the actual use study were in the
16 and younger age group, the Plan B sponsor sup-
plemented the actual use study data with reports and
behavioral studies from the medical literature. Id.
These studies enrolled more than 1,000 subjects ages
16 and younger, Pls.' Ex. A-3 at T-30868; Pls.' A-2 at
T-30809, and lent further support to a finding that
young adolescents can use Plan B safely in an OTC
setting.

On December 16, 2003, the Advisory Committee
voted 23 to 4 in favor of the recommendation to ap-
prove Plan B for over-the-counter status without age
or point-of-sale restrictions. Def.'s Ex. 2 at T-10792; it
voted unanimously that Plan B is safe for use in a
non-prescription setting, and voted 27 to 1 that the
actual use study data submitted by the Plan B sponsor
could be generalized to the overall population of po-
tential non-prescription users of Plan B, i.e., data from
older age groups could be extrapolated to younger
ones. Id. at T-10754. Only a few panel members raised
questions concerning the quality of the supporting
data regarding young adolescent use and possible
substitution of Plan B for other forms of contracep-
tion. See id. at T-10753-56, 10763-67, 10776-78,
10789, 10792. And, significantly, at least two of those
raising such concerns appear to have been appointed
by the Commissioner's office to achieve ideological
balance on the panel. See Pls.' Ex. D-1 at Houn Dep.
33:19-35:20.

While the Advisory Committee does not have the
final say regarding the OTC switch applications, the
FDA has followed advisory committee recommenda-
tions in every OTC switch application in the last
decade: Of the 23 OTC switch applications reviewed
by advisory committees from 1994 to 2004, the Plan B
over-the-counter switch application was the only one
that was not approved after the joint committee voted
to recommend its approval. See Pls.' Ex. B, GAO
Report at 1-4, 34-35. A meeting in late December
2003 or early January 2004 sheds light on the reasons

© 2013 Thomson Reuters. No Claim to Orig. US Gov. Works.

Pls-Add-10Case: 13-1690 Document: 57-2 Page: 13 05/20/2013 943308 98

Page 11

603 F.Supp.2d 519
(Cite as: 603 F.Supp.2d 519)

for this departure from the FDA's decision-making
process.

*529 During that meeting, Dr. Woodcock, Acting
Deputy Commissioner, and Dr. Steven Galson, Acting
Director for the Center for Drug Evaluation and Re-
search (CDER), told their subordinates, Drs. Jenkins
and Kweder, “that Plan B could not be approved on
this round,” Pls.' Ex. D-2 at Kweder Dep. 45:6-7, and
that the decision was to be made at the level of CDER
Director or at the Commissioner's level. Pls.' Ex. D-1
at Jenkins Dep. 17:9-11, 18:16-17. This was a depar-
ture from usual FDA procedures because under its
“normal schema” a switch to OTC of a first in class
drug, such as Plan B, would be handled at the Office
Director level and would not require approval or sign
off by the Commissioner's office. Id. at 16:9-21.
Moreover, they were told that the White House had
been involved in the decision on Plan B. Dr. Kweder
testified that Dr. Woodcock had told her at that
meeting that:

Dr. McClellan had [not] made [the decision] on his
own but ... the White House was involved ... we
were told, and that it was made very clear that there
were a lot of constituents who would be very un-
happy with ... an over-the-counter Plan B, and ...
[there] was part of the public that needed to have the
message that we were taking adolescents and re-
productive issues seriously.

Pls.' Ex. D-2 at Kweder Dep. 56:18-57:4; Pls.'
Reply Ex. 4 at Kweder Dep. 72:20-73:4. Moreover,
the pressure coming from the White House appears to
have been transmitted down by the Commissioner's
office in such a way as to significantly affect Dr.
Galson's position on the over-the-counter switch ap-
plication. While Dr. Galson would ultimately concur
with Commissioner McClellan's decision and sign the
Not-Approvable letter in May 2004, Dr. Jenkins tes-
tified

that during the time that we were reviewing the
Application before we went to the Advisory Com-

mittee, I never had any indication from either Dr.
Woodcock or Dr. Galson that they felt that the
product should not be available over the counter
without age restriction, so nothing in their commu-
nications with me ever led me to think that they
were thinking that this should not be approved or
should not be available.

if he didn't agree with

Pls.' Reply Ex. 4 at Jenkins Dep. 231:18-232:4.
Dr. Jenkins further testified that “[o]ver the course of
the time after [this] lunch meeting” and subsequent
meetings with review staff and the Commissioner
“there were occasions where ... Dr. Galson ... told me
that he felt that he didn't have a choice, and ... that he
wasn't sure that he would be allowed to remain as
Center Director
the
[Not-Approvable] Action.” Id. at 232:5-17; see also
Pls.' Ex. D-1 at Jenkins Dep. 51:2-8. Dr. Jenkins'
testimony is corroborated by the deposition testimony
of Dr. Susan Wood, then-Assistant Commissioner for
Women's Health and Director of the FDA Office of
Women's Health. Dr. Wood testified that Dr. Galson
conveyed that “he felt that he would not be able to
work with the leadership of the Agency in an effective
manner if [the Not-Approvable] letter ... did not go
through.” Pls.' Reply Ex. 4 at Wood Dep. 24:13-16.

Nevertheless, FDA review staff continued their
“first review cycle” for the OTC switch application
submitted by the Plan B sponsor. On January 9, 2004,
Dr. Curtis Rosebraugh, Deputy Director of the Divi-
sion of OTC Drugs, recommended approval of the
application submitted by the Plan B sponsor, con-
cluding that Plan B has a “low misuse and abuse po-
tential” and is “safe and effective.” Pls.' Ex. F-1 at
T-30454. Moreover, he suggested that Plan B could
decrease unwanted teen pregnancy by up to 70 percent
and reduce teen abortions. Id. at T-30455.

*530 On January 15, 2004, less than a week after
Rosebraugh circulated his memorandum, and before
other FDA offices had completed their respective
reviews, Dr. Galson met with and informed members

© 2013 Thomson Reuters. No Claim to Orig. US Gov. Works.

Pls-Add-11Case: 13-1690 Document: 57-2 Page: 14 05/20/2013 943308 98

Page 12

603 F.Supp.2d 519
(Cite as: 603 F.Supp.2d 519)

of the ODE III, ODE V and OND that the Commis-
sioner's office had decided that the FDA would issue a
Not-Approvable letter because of a lack of adequate
data to support appropriate use of Plan B by adoles-
cents under 16. Def.'s Ex. 3 at T-30666-70; Pls.' Ex.
D-1 at Houn Dep. 21:7-12. There is evidence that
Commissioner McClellan made this decision before
FDA staff had completed their scientific reviews of
that data. See Pls.' Ex. B, GAO Report at 21-22. In-
deed, Dr. Houn testified that it was “very unusual” that
Dr. Galson had informed review staff at the January
15, 2004 meeting that the data was insufficient be-
cause

we had not finished the evaluation process, and we
were in the middle of getting data on the question of
adolescent use of emergency contraception. So if
we were to continue an evidence-based approach,
we would hope to have all of the evidence in hand
before an evaluation and decision was made.

Pls.' Ex. D-1 at Houn Dep. 22:3-9. This testimony
is corroborated by Dr. Jenkins' deposition testimony:
[F]or the Commissioner to convey through Dr.
Galson a definitive opinion on the Application and
an Action before the reviews were completed and
before it had gone up through the subsequent levels
of the organization is something I've never en-
countered before.

Id. at Jenkins Dep. 33:12-17; see also id. at
29:7-19. The timing of the Commissioner's decision is
particularly striking in light of Dr. Galson's ac-
knowledgment, at the January 15 meeting, that addi-
tional data, which Dr. Galson and the Commissioner
were not familiar with, existed on the use of Plan B in
adolescent girls in that age group. Def.'s Ex. 3 at
T-30666-70. Indeed, as part of its OTC switch appli-
cation, the Plan B sponsor submitted eight behavioral
studies on the use of emergency contraceptives. See
Pls.' Ex. F-1 at T-30448-50.

Dr. Woodcock called Dr. Houn a day or two after
the January 15 meeting at which the decision not to
approve the Plan B sponsor's OTC switch application
was announced to find out the “reaction [of] the team.
[Dr. Woodcock] conveyed to [Dr. Houn] ... that this
was the only way to go to issue a non-approval letter to
appease the [present] administration's constituents.”
Pls.' Ex. D-1 at Houn Dep. 59:16-20; id. at 59:21-60:6;
Pls.' Ex. D-2 at Kweder Dep. 55:14-56:7. Neverthe-
less, a week after the January meeting, Dr. Jonca Bull,
Director of ODE V, circulated a memorandum which
concurred with the favorable reviews submitted by a
number of other FDA staff reviewers, supra. Dr. Bull
wrote

There is no basis on which to assume that young
women of child bearing potential would suddenly
become promiscuous because of this product. In-
deed, the data submitted evidenced a decrease in
sexual activity short term.... I am unable to identify
evidence in the medical literature to support the
assertion that the availability of contraception di-
rectly increases high risk sexual behavior.

Pls.' Ex. F-1 at T-30649-50 (emphasis added). Dr.
Bull concluded that the Plan B sponsor “adequately
demonstrated that women of reproductive potential
across relevant age subgroups can use the product
appropriately.” Id. at T-30651.

In mid-February, FDA staff attempted to address
Commissioner McClellan's expressed concerns re-
garding the impact of non-prescription access to Plan
B on young adolescents. They presented him with an
*531 analysis of additional data available on the OTC
use of Plan B by adolescents. Def.'s Ex. 3 at
T-30720-21. Staff concluded that “the benefits of
timely access outweighed any risk for all women,
including adolescents,” and supported OTC availabil-
ity without any age restriction. Id. at T-30720. Com-
missioner McClellan, however, was “not convinced
the studies had enough power to determine if there
were behavioral differences between adults and ado-

© 2013 Thomson Reuters. No Claim to Orig. US Gov. Works.

Pls-Add-12Case: 13-1690 Document: 57-2 Page: 15 05/20/2013 943308 98

Page 13

603 F.Supp.2d 519
(Cite as: 603 F.Supp.2d 519)

lescents” and directed CDER to work with the drug's
sponsor on a marketing plan to restrict Plan B access
to appropriate age groups. Id. at T-30721.

Responding to these concerns, the Plan B sponsor
indicated its willingness to modify its original pro-
posal that would have made Plan B available
over-the-counter without any age restriction. Instead,
the Plan B sponsor submitted an informal proposal to
market Plan B OTC to consumers age 16 and over,
while maintaining the product's prescription status for
consumers under age 16. Def.'s Ex. 4 at SNDA
001-004. Under this proposal, both prescription and
OTC Plan B would be marketed in the same package
and would be distributed from behind pharmacy
counters with proof-of-age required. Id. Notwith-
standing this revised proposal, FDA scientific review
staff uniformly and strongly supported approval of
Plan B for OTC sales without age or point-of-sale
restrictions. Numerous scientists submitted memo-
randa to this effect in March and April 2004. Signifi-
cantly, the memoranda squarely addressed upper
management concerns that there was insufficient data
on young adolescent use. Reviewers analyzed the
actual use data as well as data from five other studies
that were submitted with the initial SNDA. Of the
more than 11,000 enrollees in those studies, just over
1,000 were under 16, nearly 2,000 were 17 or younger,
and at least 200 of the subjects in one study were aged
13 to 15. Pls.' Ex. A-3 at T-30868; Pls.' Ex. A-2 at
T-30809 & n. 5.

In reviewing the available data, Dr. Daniel Davis,
Division of Reproductive and Urologic Drug Products
(DRUDP) Medical Officer, squarely addressed
“concern [s] over the OTC availability of emergency
contraception and the effect that this might have on
adolescent behavior (e.g., increasing sexual promis-
cuity).” Pls.' Ex. A-2 at T-30810. Dr. Davis found that
the data did not support these concerns, rather it
“suggest[ed] that ready access to OTC Plan B ...
would have little impact on sexual behavior and con-
traceptive practices in younger adolescents.” Id. at

T-30812. Dr. Rosebraugh concluded similarly:

The data ... is quite compelling to dispel any poten-
tial concerns regarding adolescent use or changes in
sexual[ ] behaviors associated with plan B use.... In
terms of OTC switch applications, this drug has
more information available to allow us to predict
consumer behaviors than any drug the Divisions
ha[ve] approved for switch in recent memory. If this
is not enough data upon which to base a decision, it
is unclear what would constitute enough data or
even if that is an obtainable goal.

Id. at T-30757 (emphasis added).

The positive reviews from staff in favor of the
OTC switch without age restriction continued: In
April 2004, Dr. Donna Griebel, Deputy Director of
Division of Reproductive and Urologic Drug Products
(DRUDP), concluded that the risk-benefit ratio of
non-prescription access to Plan B supported its ap-
proval for OTC status. Pls.' Ex. A-3 at T-30829-79.
She concluded that there was no justification for “re-
strict[ing] access to the benefit of this product on the
basis of age.” Id. at T-30877. Dr. Julie Beitz, Deputy
Director of ODE III, also found sufficient data on the
*532 safe and effective use of Plan B to approve use at
all age levels. Id. at T-30881-90. With respect to the
younger adolescent group, Dr. Beitz noted not only
that “[o]ver a thousand adolescents aged <=16 years
have been evaluated” but that the “[f]indings regard-
ing the use of EC [emergency contraception], fre-
quency of unprotected sex, and frequency of preg-
nancy and STDs are remarkably consistent across
studies, clinical settings, and age strata.” Id. at
T-30888.

Later in April 2004, Dr. Jenkins, Director of the
Office of new Drugs, issued his review concurring
with the recommendations of ODE III and ODE V. Id.
at T-30897-99. He concluded

© 2013 Thomson Reuters. No Claim to Orig. US Gov. Works.

Pls-Add-13Case: 13-1690 Document: 57-2 Page: 16 05/20/2013 943308 98

Page 14

603 F.Supp.2d 519
(Cite as: 603 F.Supp.2d 519)

that increased access for adolescents to emergency
contraception did not result in inappropriate use of
Plan B as a routine form of contraception, an in-
crease in the number of sexual partners, an increase
in the frequency of unprotected intercourse, or an
increase in the frequency of sexually transmitted
diseases.

Id. at T-30898 (emphasis added). Responding
directly to concerns that the label comprehension and
actual use studies enrolled too few young adolescents,
Dr. Jenkins noted:

While it is true that the number of adolescents en-
rolled in the sponsor's studies was relatively small,
these studies did not exclude adolescent women
from enrollment and were conducted in settings that
would be expected to captur