I 
109TH CONGRESS 
1ST SESSION H. R. 4229 
To require the Commissioner of Food and Drugs to determine whether to 
allow the marketing of Plan B as a prescription drug for women 15 
years of age or younger and a nonprescription drug for women 16 
years of age or older, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
NOVEMBER 3, 2005 
Mrs. MALONEY (for herself, Mr. SHAYS, Mr. INSLEE, Mr. CROWLEY, Ms. 
WASSERMAN SCHULTZ, Mr. BISHOP of New York, Mr. FARR, Mrs. 
CAPPS, Ms. ESHOO, Mr. BERMAN, Ms. LINDA T. SA´NCHEZ of California, 
Ms. SCHAKOWSKY, Mr. WAXMAN, Ms. BALDWIN, Mr. DEFAZIO, Mr. 
ROTHMAN, Mr. HONDA, Mr. FILNER, Ms. SOLIS, Mr. FRANK of Massa-
chusetts, Mr. MORAN of Virginia, Ms. MATSUI, Mr. GRIJALVA, Mr. 
LARSEN of Washington, Mr. GUTIERREZ, Mr. ENGEL, Ms. MCCOLLUM 
of Minnesota, Mr. KENNEDY of Rhode Island, Mr. HINCHEY, Mr. 
MCGOVERN, Mr. ACKERMAN, Mr. SABO, Mrs. MCCARTHY, Ms. 
DELAURO, Mr. EVANS, Mr. ISRAEL, Ms. WOOLSEY, Mr. KUCINICH, and 
Mr. WU) introduced the following bill; which was referred to the Com-
mittee on Energy and Commerce 
A BILL 
To require the Commissioner of Food and Drugs to deter-
mine whether to allow the marketing of Plan B as a 
prescription drug for women 15 years of age or younger 
and a nonprescription drug for women 16 years of age 
or older, and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Plan B for Plan B 
Act of 2005’’. 
SEC. 2. FINDINGS. 
The Congress finds as follows: 
(1) The Food and Drug Administration has de-
clared Plan B to be safe and effective in preventing 
unintended pregnancy, reducing the risk by as much 
as 89 percent if taken within days of unprotected 
intercourse and up to 95 percent if taken in the first 
24 hours. 
(2) On April 21, 2003, product manufacturers 
Women’s Capital Corporation, controlled by Barr 
Pharmaceuticals, submitted a supplemental new 
drug application to the Food and Drug Administra-
tion to switch Plan B from prescription-only to over- 
the-counter status for women of all ages. 
(3) On December 16, 2003, a joint panel of the 
Food and Drug Administration’s Reproductive 
Health Drugs Advisory Committee and Non-Pre-
scription Drugs Advisory Committee voted 28–0 that 
Plan B could be used safely in a non-prescription 
setting. 
(4) On December 16, 2003, a joint panel of the 
Food and Drug Administration’s Reproductive 
Health Drugs Advisory Committee and Non-Pre-
scription Drugs Advisory Committee voted 23–4 to 
recommend that the Food and Drug Administration 
approve the application to make Plan B available 
over-the-counter for women of all ages. 
(5) On May 6, 2004, the Food and Drug Ad-
ministration deemed the application not approvable, 
directly contradicting the overwhelming weight of 
their own scientific evidence. 
(6) At the suggestion of the Food and Drug 
Administration, Barr Pharmaceutical submitted a 
formal response, dated July 16, 2003, to the Admin-
istration’s non-approvable determination, supporting 
the marketing of Plan B as a prescription drug for 
women 15 years of age or younger and a non-
prescription drug for women 16 years of age or 
older. 
(7) On January 21, 2005, the Food and Drug 
Administration delayed issuing a decision on the 
Plan B application. 
(8) A letter dated July 13, 2005, from Sec-
retary of Health and Human Services Michael O. 
Leavitt to Chairman Mike Enzi of the Committee on 
Health, Education, Labor, and Pensions of the Sen-
ate stated that the Food and Drug Administration
would act on the Plan B application by September 
1, 2005. 
(9) On August 26, 2005, the Food and Drug 
Administration did not approve or disapprove the 
Plan B application, and instead decided to publish 
an advance notice of proposed rulemaking in the 
Federal Register, even while concluding that ‘‘the 
available scientific data are sufficient to support the 
safe use of Plan B as an OTC product . . . for 
women who are 17 years of age or older’’. 
(10) On August 31, 2005, Susan F. Wood, 
serving as the Food and Drug Administration’s as-
sistant commissioner for women’s health and direc-
tor of the Office of Women’s Health, resigned her 
position because of the Administration’s refusal to 
issue a final decision on the Plan B application, say-
ing that she could not serve at the Administration 
when ‘‘scientific and clinical evidence, fully evaluated 
and recommended for approval by the professional 
staff [at the Administration], has been overruled’’. 
(11) On September 1, 2005, the Food and 
Drug Administration issued an advance notice of 
proposed rulemaking (70 FR 52050) to request 
comment by November 1, 2005, on whether to ini-
tiate a rulemaking to codify the Administration’s in-
terpretation of section 503(b) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 353(b)) regard-
ing when an active ingredient may be simultaneously 
marketed in both a prescription drug product and an 
over-the-counter (OTC) drug product, potentially 
adding years of unnecessary regulatory delays to an 
already extended process which is keeping Plan B 
from over-the-counter status. 
SEC. 3. DECISION BY FDA ON MARKETING OF EMERGENCY 
CONTRACEPTION. 
(a) IN GENERAL.—Not later than 30 days after the 
date of the enactment of this Act, the Commissioner of 
Food and Drugs shall approve or disapprove the supple-
mental new drug application for Plan B, as amended by 
the formal response to the non-approvable letter. 
(b) FAILURE TO APPROVE OR DISAPPROVE.—If the 
Commissioner fails to approve or disapprove the applica-
tion described in subsection (a) by the deadline described 
in such subsection— 
(1) the Commissioner is deemed to have ap-
proved the application; and 
(2) such deemed approval shall continue in ef-
fect unless the Commissioner publishes in the Fed-
eral Register a determination to approve or dis-
approve the application.
(c) DEFINITIONS.—In this Act: 
(1) The term ‘‘Commissioner’’ means the Com-
missioner of Food and Drugs. 
(2) The term ‘‘formal response’’ means the for-
mal response, dated July 16, 2003, to the non-ap-
provable letter, supporting the marketing of Plan B 
as a prescription drug for women 15 years of age or 
younger and a nonprescription drug for women 16 
years of age or older. 
(3) The term ‘‘Plan B’’ means 0.75 mg 
levonorgestrel tablets. 
(4) The term ‘‘prescription drug’’ means a drug 
subject to section 503(b)(1) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 353(b)(1)). 
(5) The term ‘‘supplemental new drug applica-
tion for Plan B’’ means the supplemental new drug 
application submitted under section 505(b) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355(b)) on April 21, 2003, by product manufactur-
ers Women’s Capital Corporation, controlled by Barr 
Pharmaceuticals, to the Food and Drug Administra-
tion to switch Plan B from prescription-only to non-
prescription status for women of all ages. 
(6) The term ‘‘non-approvable letter’’ means 
the non-approvable letter dated May 6, 2004, from