I 

114TH CONGRESS 

1ST SESSION H. R. 3163 

To ensure timely access to affordable birth control for women. 

IN THE HOUSE OF REPRESENTATIVES 

JULY 22, 2015 

Ms. DUCKWORTH (for herself, Mr. CROWLEY, Mr. MURPHY of Florida, Mr. 

RANGEL, Mr. GRIJALVA, Ms. NORTON, Mr. PAYNE, Ms. CLARK of Massachusetts, Mr. BERA, Mr. TED LIEU of California, Mr. MCDERMOTT, Mr. 

POCAN, Mr. BLUMENAUER, Ms. BONAMICI, Mrs. WATSON COLEMAN, Mr. 

RYAN of Ohio, Mr. NADLER, Ms. DEGETTE, Ms. FRANKEL of Florida, 

Ms. CASTOR of Florida, Ms. DELBENE, Mr. DEUTCH, Ms. SLAUGHTER, 

Mr. LEWIS, Mrs. BEATTY, Mr. BEYER, Ms. WASSERMAN SCHULTZ, Mr. 

DAVID SCOTT of Georgia, Miss RICE of New York, Mr. ELLISON, Ms. 

JACKSON LEE, Ms. SPEIER, Mr. GRAYSON, Mrs. DAVIS of California, Mr. 

CUMMINGS, Mrs. CAPPS, Ms. KUSTER, Ms. CLARKE of New York, Ms. 

SCHAKOWSKY, Ms. DELAURO, Mr. WELCH, Ms. HAHN, Ms. WILSON of 

Florida, Mr. ENGEL, Mr. HONDA, Mr. COHEN, Ms. EDWARDS, Mr. 

MOULTON, Ms. PINGREE, Ms. TITUS, Mr. PETERS, Mr. HASTINGS, Mr. 

VAN HOLLEN, Mr. CAPUANO, Mr. BRENDAN F. BOYLE of Pennsylvania, 

Mr. CONYERS, Mr. SEAN PATRICK MALONEY of New York, Mr. 

DESAULNIER, Mr. CA ́RDENAS, Mr. TONKO, Ms. MOORE, Mrs. LAWRENCE, Mr. DEFAZIO, Ms. BROWNLEY of California, Mr. QUIGLEY, Ms. 

MCCOLLUM, Mrs. BUSTOS, Ms. LEE, Mr. LARSEN of Washington, Ms. 

MICHELLE LUJAN GRISHAM of New Mexico, Mr. BRADY of Pennsylvania, 

Mr. DANNY K. DAVIS of Illinois, Mr. JOHNSON of Georgia, Ms. JUDY

CHU of California, Mr. O’ROURKE, Mr. LOEBSACK, and Ms. ROYBALALLARD) introduced the following bill; which was referred to the Committee on Energy and Commerce 

A BILL 

To ensure timely access to affordable birth control for 

women. 


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

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Affordability Is Access 

5 Act’’. 

6 SEC. 2. PURPOSE. 

7 The purpose of this Act is to ensure timely access 

8 to affordable birth control by requiring coverage without 

9 cost-sharing for oral birth control for routine, daily use 

10 that is approved by, or otherwise legally marketed under 

11 regulation by, the Food and Drug Administration for use 

12 by women without a prescription. 

13 SEC. 3. FINDINGS. 

14 Congress makes the following findings: 

15 (1) Access to the full range of health benefits 

16 and preventive services, including access to birth 

17 control, as guaranteed under Federal law, provides 

18 all people of the United States with the opportunity 

19 to lead healthier and more productive lives. 

20 (2) Birth control is a critical health care benefit 

21 and service for women. Almost all women use birth 

22 control at some point in their lifetimes. The Centers 

23 for Disease Control and Prevention declared it one 

24 of the Ten Great Public Health Achievements of the 

25 20th Century. 


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1 (3) Birth control prevents and reduces unin2 tended pregnancies and provides many health and 

3 socioeconomic benefits for women. Women with ac4 cess to birth control are more likely to have higher 

5 educational and career achievement, and to earn 

6 higher wages. 

7 (4) Affordability and timely access have long 

8 been barriers for women being able to use birth con9 trol. Many women struggle to obtain the birth con10 trol they need because of cost or other access bar11 riers, which has contributed to the high unintended 

12 pregnancy rate in the United States. A national sur13 vey found that 1 in 3 women have struggled to af14 ford birth control at some point in their lives, and 

15 as a result, have used birth control inconsistently. 

16 The rate is even higher for young women who are 

17 most likely to experience an unintended pregnancy. 

18 (5) Three separate studies have found that lack 

19 of health coverage is significantly associated with re20 duced use of prescription contraceptive methods, in21 cluding birth control. 

22 (6) The Patient Protection and Affordable Care 

23 Act (Public Law 111–148) sought to remove bar24 riers to care and improve access by requiring all new 

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1 ices without cost-sharing, which include women’s 

2 preventive services, including all contraceptive meth3 ods, including birth control and sterilization for 

4 women approved by the Food and Drug Administra5 tion and related education and counseling. 

6 (7) The Patient Protection and Affordable Care 

7 Act women’s preventive services benefit has signifi8 cantly improved women’s access to birth control, in9 cluding oral birth control for routine, daily use. The 

10 Department of Health and Human Services has re11 ported that, as of 2014, more than 55,000,000 

12 women are benefitting from coverage without cost13 sharing for women’s preventive services, including 

14 birth control, under the Patient Protection and Af15 fordable Care Act. Women have saved more than 

16 $483,000,000 in out-of-pocket costs for birth control 

17 with no copayments in 2012 compared to 2013, an 

18 average savings of $269 per woman. 

19 (8) The most appropriate method of birth con20 trol varies according to each individual woman’s 

21 needs, medical history, and stage of life. For in22 stance, women may have medical contraindications 

23 that limit their ability to use certain birth control 

24 methods. It is critical that the full range of birth 

25 control methods approved by the Food and Drug 


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1 Administration are available and covered without 

2 cost-sharing in order to ensure that each woman has 

3 access to the birth control method that best meets 

4 her needs. 

5 (9) The determination as to whether a drug 

6 should be available for use without a prescription is 

7 appropriately and solely made by the Food and Drug 

8 Administration. To ensure the safety and efficacy of 

9 a drug, including a drug available for over-the10 counter use, the appropriate scientific and medical 

11 personnel at the Food and Drug Administration, 

12 often with input from independent advisory panels of 

13 experts, review clinical and other data relating to the 

14 safety and efficacy of the drug. This scientific and 

15 medical review can occur as part of the Food and 

16 Drug Administration’s over-the-counter drug review 

17 for potential inclusion in a monograph as generally 

18 recognized as safe and effective, or as part of the re19 view of a new drug application (or an abbreviated 

20 new drug application). As part of these regulatory 

21 processes, the appropriate scientific and medical per22 sonnel review clinical and other data, including data 

23 generated in controlled clinical trials. The Food and 

24 Drug Administration also reviews consumer studies 

25 and monitors post-marketing safety data. All of 


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1 these processes ensure that the appropriate scientific 

2 and medical personnel make the determination of 

3 safety, quality, and efficacy of drugs marketed to 

4 the people of the United States. 

5 (10) Leading women’s health experts, providers, 

6 and medical associations, including the American 

7 College of Obstetricians and Gynecologists and the 

8 American Academy of Family Physicians, support 

9 full insurance coverage and increased access to oral 

10 birth control over-the-counter. In 2012, the Amer11 ican College of Obstetricians and Gynecologists 

12 issued a Committee Opinion recommending approval 

13 by the Food and Drug Administration of certain 

14 forms of birth control for over-the-counter use to in15 crease timely access to birth control. Furthermore, 

16 data demonstrates that birth control that is available 

17 over-the-counter has public support and would in18 crease birth control usage and continuation. The 

19 Committee Opinion followed similar recommenda20 tions made by leading reproductive health experts 

21 and published in the American Journal of Public 

22 Health. 

23 (11) Research shows that birth control available 

24 over-the-counter, as an addition to, not a substitute 

25 for, the women’s preventive health benefit under the 


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1 Patient Protection and Affordable Care Act, would 

2 increase accessibility for oral birth control for rou3 tine, daily use. 

4 SEC. 4. SENSE OF THE HOUSE OF REPRESENTATIVES. 

5 It is the sense of the House of Representatives that— 

6 (1) in order to increase women’s access to oral 

7 birth control, it must be both easier to obtain and 

8 affordable and, to make it either easier to obtain or 

9 more affordable, but not both, is to leave unaccept10 able barriers in place for women; 

11 (2) it is imperative that the entities that re12 search and develop oral birth control and whose 

13 medical and scientific experts have developed clinical 

14 and other evidence that oral birth control for rou15 tine, daily use is safe and effective for women when 

16 sold without a prescription, apply to the Food and 

17 Drug Administration for review and approval for 

18 sale of such birth control without a prescription; 

19 (3) upon the receipt of such an application, the 

20 Food and Drug Administration should determine 

21 whether the oral birth control meets the rigorous 

22 safety, efficacy, and quality standards for over-the23 counter use under the Federal Food, Drug, and Cos24 metic Act (21 U.S.C. 301 et seq.), and if the prod25 uct meets those standards, the Food and Drug AdVerDate Sep 11 2014 02:26 Jul 25, 2015 Jkt 049200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H3163.IH H3163

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1 ministration should approve the application without 

2 delay; and 

3 (4) if and when the Food and Drug Adminis4 tration approves an oral birth control that is avail5 able over-the-counter, such birth control should be 

6 covered by health insurance, without a prescription 

7 and without cost-sharing. 

8 SEC. 5. ENSURING COVERAGE OF ORAL BIRTH CONTROL 

9 FOR USE WITHOUT A PRESCRIPTION. 

10 Section 2713(a)(4) of the Public Health Service Act 

11 (42 U.S.C. 300gg–13(a)(4)) is amended by inserting ‘‘(in12 cluding oral contraceptives for routine, daily use approved 

13 by the Food and Drug Administration for use without a 

14 prescription, even if the individual does not have a pre15 scription for such contraceptive)’’ after ‘‘additional pre16 ventive care’’. 

17 SEC. 6. RULES OF CONSTRUCTION. 

18 (a) NON-INTERFERENCE WITH FDA REGULA19 TION.—Nothing in this Act (or the amendment made by 

20 this Act) shall be construed to modify or interfere with 

21 Food and Drug Administration processes to review or ap22 prove, or otherwise determine the safety and efficacy of, 

23 and make available, non-prescription drugs or devices, 

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1 erations of the Food and Drug Administration, or alter 

2 any other authority of the Food and Drug Administration. 

3 (b) NON-PREEMPTION.—Nothing in this Act (or the 

4 amendment made by this Act) preempts any provision of 

5 Federal or State law to the extent that such Federal or 

6 State law provides protections for consumers that are 

7 greater than the protections provided for in this Act. 

8 SEC. 7. DUTIES OF RETAILERS TO ENSURE ACCESS TO 

9 ORAL BIRTH CONTROL FOR USE WITHOUT A 

10 PRESCRIPTION. 

11 (a) IN GENERAL.—Any retailer that stocks oral birth 

12 control for routine, daily use that is approved by, or other13 wise legally marketed under regulation by, the Food and 

14 Drug Administration for use without a prescription may 

15 not interfere with an individual’s access to or purchase 

16 of such birth control or access to medically accurate, com17 prehensive information about such birth control. 

18 (b) LIMITATION.—Nothing in this section shall pro19 hibit a retailer that stocks oral birth control for routine, 

20 daily use from refusing to provide an individual with such 

21 oral birth control that is approved by, or otherwise legally 

22 marketed under regulation by, the Food and Drug Admin23 istration if the individual is unable to pay for the birth 

24 control, directly or through insurance coverage. 

Æ 


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