I 

108TH CONGRESS 

2D SESSION H. R. 4377 

To provide for the review by the Commissioner of Food and Drugs of the 

process by which the Food and Drug Administration made the decision 

not to approve the commercial distribution of the emergency-contraceptive 

drug Plan B as an over-the-counter drug, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

MAY 17, 2004 

Mrs. MALONEY (for herself, Mr. GRIJALVA, Mr. CONYERS, Mr. JACKSON of 

Illinois, Mrs. CAPPS, Ms. MILLENDER-MCDONALD, Mr. LANTOS, Mr. 

CROWLEY, Ms. JACKSON-LEE of Texas, Ms. WOOLSEY, Mr. NADLER, Mr. 

FILNER, Ms. SCHAKOWSKY, Mr. FRANK of Massachusetts, Ms. LEE, Ms. 

DELAURO, and Mr. SHAYS) introduced the following bill; which was referred to the Committee on Energy and Commerce 

A BILL 

To provide for the review by the Commissioner of Food 

and Drugs of the process by which the Food and Drug 

Administration made the decision not to approve the 

commercial distribution of the emergency-contraceptive 

drug Plan B as an over-the-counter drug, and for other 

purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 
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1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Science Over Politics 

3 Act’’. 

4 SEC. 2. FINDINGS. 

5 The Congress finds as follows: 

6 (1) Emergency contraceptive pills (‘‘ECPs’’) are 

7 approved for use by the Food and Drug Administra8 tion (‘‘FDA’’). 

9 (2) Emergency contraceptive pills are a con10 centrated dosage of ordinary birth control pills that 

11 can dramatically reduce a woman’s chance of becom12 ing pregnant. 

13 (3) If ECPs are taken within 72 hours of con14 traceptive failure or unprotected sex, ECPs can re15 duce a woman’s risk of pregnancy by up to 89 per16 cent. 

17 (4) Emergency contraceptive pills do not cause 

18 abortion but rather prevent pregnancy by inhibiting 

19 ovulation, fertilization, or implantation before a 

20 pregnancy occurs. 

21 (5) Emergency contraception cannot interrupt 

22 or disrupt an established pregnancy. 

23 (6) Increased use of ECPs could reduce the 

24 number of unintended pregnancies and abortions by 

25 half. 
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1 (7) A 2002 study revealed that ECP use was 

2 likely responsible for up to 43 percent of the decline 

3 in abortions between 1994 and 2000, with ECP use 

4 preventing over 50,000 abortions in 2000 alone. 

5 (8) Over-the-counter sales of ECPs would be 

6 particularly beneficial for sexual assault victims as 

7 approximately 25,000 women per year in the United 

8 States become pregnant as a result of rape. An esti9 mated 22,000 of these pregnancies, 88 percent, 

10 could be prevented if sexual assault victims had 

11 timely access to emergency contraception. 

12 (9) More than 70 organizations, including the 

13 American Nurses Association, the American College 

14 of Obstetricians and Gynecologists, the American 

15 Academy of Pediatrics, the American Medical Asso16 ciation, the American Public Health Association, and 

17 the Association of Reproductive Health Profes18 sionals, support over-the-counter access to ECPs. 

19 (10) On April 21, 2003, product manufacturers 

20 Women’s Capital Corporation submitted an applica21 tion to the Food and Drug Administration request22 ing to switch the emergency contraceptive Plan B 

23 from prescription-only to over-the-counter (‘‘OTC’’) 

24 status. 
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1 (11) ECPs meet all the customary FDA criteria 

2 for over-the-counter status in that they are safe and 

3 effective, are not associated with any serious or 

4 harmful side-effects, are easily self-administered, 

5 and require no need for medical supervision. More6 over, ECPs are not harmful to an existing preg7 nancy and their use does not lead to riskier behavior 

8 or less frequent use of other forms of contraception, 

9 has no potential for overdose or addiction, is not 

10 harmful to an existing pregnancy, is easily self-ad11 ministered, and requires no need for medical screen12 ing. 

13 (12) FDA staff and experts appointed to the 

14 advisory committees considered volumes of evidence 

15 showing that making Plan B available over-the16 counter was safe and effective for women of all re17 productive age. 

18 (13) On December 16, 2003, a joint panel of 

19 the FDA’s Reproductive Health Drugs Advisory 

20 Committee and Non-Prescription Drugs Advisory 

21 Committee voted 28–0 that Plan B could be safely 

22 sold as an over-the-counter medication. 

23 (14) On December 16, 2003, a joint panel of 

24 the FDA’s Reproductive Health Drugs Advisory 

25 Committee and Non-prescription Drugs Advisory 
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1 Committee voted 23–4 to recommend that the FDA 

2 approve the application to make Plan B available 

3 over-the-counter for women of all ages. 

4 (15) The FDA’s rejection of over-the-counter 

5 status for Plan B on May 6, 2004, directly contra6 dicted the overwhelming weight of scientific evi7 dence. 

8 (16) The limited options offered by the FDA 

9 for future consideration of over-the-counter sale of 

10 Plan B are not warranted by the volumes of existing 

11 evidence and run counter to the advice of the FDA’s 

12 independent experts, staff, and precedent. 

13 (17) Evidence suggests that the FDA’s decision 

14 resulted from an unprecedented political takeover of 

15 what is supposed to be an independent scientific re16 view. 

17 SEC. 3. FDA DENIAL OF OTC STATUS FOR EMERGENCY18 CONTRACEPTIVE DRUG PLAN B; REVIEW BY 

19 COMMISSIONER OF FOOD AND DRUGS. 

20 (a) IN GENERAL.—Not later than 30 days after the 

21 date of the enactment of this Act, the Commissioner of 

22 Food and Drugs shall— 

23 (1) review the decision of the Food and Drug 

24 Administration not to approve the supplemental ap25 plication submitted under section 505(b) of the Fed-
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1 eral Food, Drug, and Cosmetic Act to obtain ap2 proval for the commercial distribution of the drug 

3 Plan B (levonorgestrel in 0.75 mg. tablet form) as 

4 a drug that is not subject to the requirements of sec5 tion 503(b)(1) of such Act (commonly known as an 

6 over-the-counter, or OTC, drug); and 

7 (2) affirm, under penalty of law, that such deci8 sion— 

9 (A) was not politically influenced; 

10 (B) was based on sound science; and 

11 (C) conformed to precedents and proce12 dures of the Food and Drug Administration. 

13 (b) PUBLICATION IN FEDERAL REGISTER.—The af14 firmation under subsection (a) shall be made through a 

15 statement published in the Federal Register. 

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