[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[S. 1532 Introduced in Senate (IS)]

114th CONGRESS
  1st Session
                                S. 1532

     To ensure timely access to affordable birth control for women.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                              June 9, 2015

   Mrs. Murray (for herself, Mrs. Boxer, Mrs. Shaheen, Mr. Reid, Mr. 
    Blumenthal, Ms. Baldwin, Mr. Bennet, Mr. Booker, Mr. Brown, Ms. 
Cantwell, Mr. Cardin, Mr. Durbin, Mrs. Feinstein, Mrs. Gillibrand, Mr. 
    Heinrich, Ms. Hirono, Mr. Kaine, Ms. Klobuchar, Mr. Leahy, Mrs. 
  McCaskill, Mr. Merkley, Ms. Mikulski, Mr. Murphy, Mr. Sanders, Mr. 
Schatz, Mr. Schumer, Mr. Franken, Ms. Stabenow, Ms. Warren, Mr. Wyden, 
 and Mr. Menendez) introduced the following bill; which was read twice 
and referred to the Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
     To ensure timely access to affordable birth control for women.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Affordability Is Access Act''.

SEC. 2. PURPOSE.

    The purpose of this Act is to ensure timely access to affordable 
birth control by requiring coverage without cost-sharing for oral birth 
control for routine, daily use that is approved by, or otherwise 
legally marketed under regulation by, the Food and Drug Administration 
for use by women without a prescription.

SEC. 3. FINDINGS.

    Congress makes the following findings:
            (1) Access to the full range of health benefits and 
        preventive services, including access to birth control, as 
        guaranteed under Federal law, provides all people of the United 
        States with the opportunity to lead healthier and more 
        productive lives.
            (2) Birth control is a critical health care benefit and 
        service for women. Almost all women use birth control at some 
        point in their lifetimes. The Centers for Disease Control and 
        Prevention declared it one of the Ten Great Public Health 
        Achievements of the 20th Century.
            (3) Birth control prevents and reduces unintended 
        pregnancies and provides many health and socioeconomic benefits 
        for women. Women with access to birth control are more likely 
        to have higher educational and career achievement, and to earn 
        higher wages.
            (4) Affordability and timely access have long been barriers 
        for women being able to use birth control. Many women struggle 
        to obtain the birth control they need because of cost or other 
        access barriers, which has contributed to the high unintended 
        pregnancy rate in the United States. A national survey found 
        that 1 in 3 women have struggled to afford birth control at 
        some point in their lives, and as a result, have used birth 
        control inconsistently. The rate is even higher for young women 
        who are most likely to experience an unintended pregnancy.
            (5) Three separate studies have found that lack of health 
        coverage is significantly associated with reduced use of 
        prescription contraceptive methods, including birth control.
            (6) The Patient Protection and Affordable Care Act (Public 
        Law 111-148) sought to remove barriers to care and improve 
        access by requiring all new health plans to cover recommended 
        preventive services without cost-sharing, which include women's 
        preventive services, including all contraceptive methods, 
        including birth control and sterilization for women approved by 
        the Food and Drug Administration and related education and 
        counseling.
            (7) The Patient Protection and Affordable Care Act women's 
        preventive services benefit has significantly improved women's 
        access to birth control, including oral birth control for 
        routine, daily use. The Department of Health and Human Services 
        has reported that, as of 2014, more than 55,000,000 women are 
        benefitting from coverage without cost-sharing for women's 
        preventive services, including birth control, under the Patient 
        Protection and Affordable Care Act. Women have saved more than 
        $483,000,000 in out-of-pocket costs for birth control with no 
        copayments in 2012 compared to 2013, an average savings of $269 
        per woman.
            (8) The most appropriate method of birth control varies 
        according to each individual woman's needs, medical history, 
        and stage of life. For instance, women may have medical 
        contraindications that limit their ability to use certain birth 
        control methods. It is critical that the full range of birth 
        control methods approved by the Food and Drug Administration 
        are available and covered without cost-sharing in order to 
        ensure that each woman has access to the birth control method 
        that best meet her needs.
            (9) The determination as to whether a drug should be 
        available for use without a prescription is appropriately and 
        solely made by the Food and Drug Administration. To ensure the 
        safety and efficacy of a drug, including a drug available for 
        over-the-counter use, the appropriate scientific and medical 
        personnel at the Food and Drug Administration, often with input 
        from independent advisory panels of experts, review clinical 
        and other data relating to the safety and efficacy of the drug. 
        This scientific and medical review can occur as part of the 
        Food and Drug Administration's over-the-counter drug review for 
        potential inclusion in a monograph as generally recognized as 
        safe and effective, or as part of the review of a new drug 
        application (or an abbreviated new drug application). As part 
        of these regulatory processes, the appropriate scientific and 
        medical personnel review clinical and other data, including 
        data generated in controlled clinical trials. The Food and Drug 
        Administration also reviews consumer studies and monitors post-
        marketing safety data. All of these processes ensure that the 
        appropriate scientific and medical personnel make the 
        determination of safety, quality, and efficacy of drugs 
        marketed to the people of the United States.
            (10) Leading women's health experts, providers, and medical 
        associations, including the American College of Obstetricians 
        and Gynecologists and the American Academy of Family 
        Physicians, support full insurance coverage and increased 
        access to oral birth control over-the-counter. In 2012, the 
        American College of Obstetricians and Gynecologists issued a 
        Committee Opinion recommending approval by the Food and Drug 
        Administration of certain forms of birth control for over-the-
        counter use to increase timely access to birth control. 
        Furthermore, data demonstrates that birth control that is 
        available over-the-counter has public support and would 
        increase birth control usage and continuation. The Committee 
        Opinion followed similar recommendations made by leading 
        reproductive health experts and published in the American 
        Journal of Public Health.
            (11) Research shows that birth control available over-the-
        counter, as an addition to, not a substitute for, the women's 
        preventive health benefit under the Patient Protection and 
        Affordable Care Act, would increase accessibility for oral 
        birth control for routine, daily use.

SEC. 4. SENSE OF THE SENATE.

    It is the sense of the Senate that--
            (1) in order to increase women's access to oral birth 
        control, it must be both easier to obtain and affordable and, 
        to make it either easier to obtain or more affordable, but not 
        both, is to leave unacceptable barriers in place for women;
            (2) it is imperative that the entities that research and 
        develop oral birth control and whose medical and scientific 
        experts have developed clinical and other evidence that oral 
        birth control for routine, daily use is safe and effective for 
        women when sold without a prescription, apply to the Food and 
        Drug Administration for review and approval for sale of such 
        birth control without a prescription;
            (3) upon the receipt of such an application, the Food and 
        Drug Administration should determine whether the oral birth 
        control meets the rigorous safety, efficacy, and quality 
        standards for over-the-counter use under the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), and if the 
        product meets those standards, the Food and Drug Administration 
        should approve the application without delay; and
            (4) if and when the Food and Drug Administration approves 
        an oral birth control that is available over-the-counter, such 
        birth control should be covered by health insurance, without a 
        prescription and without cost-sharing.

SEC. 5. ENSURING COVERAGE OF ORAL BIRTH CONTROL FOR USE WITHOUT A 
              PRESCRIPTION.

    Section 2713(a)(4) of the Public Health Service Act (42 U.S.C. 
300gg-13(a)(4)) is amended by inserting ``(including oral 
contraceptives for routine, daily use approved by the Food and Drug 
Administration for use without a prescription, even if the individual 
does not have a prescription for such contraceptive)'' after 
``additional preventive care''.

SEC. 6. RULES OF CONSTRUCTION.

    (a) Non-Interference With FDA Regulation.--Nothing in this Act (or 
the amendment made by this Act) shall be construed to modify or 
interfere with Food and Drug Administration processes to review or 
approve, or otherwise determine the safety and efficacy of, and make 
available, non-prescription drugs or devices, modify or interfere with 
the scientific and medical considerations of the Food and Drug 
Administration, or alter any other authority of the Food and Drug 
Administration.
    (b) Non-Preemption.--Nothing in this Act (or the amendment made by 
this Act) preempts any provision of Federal or State law to the extent 
that such Federal or State law provides protections for consumers that 
are greater than the protections provided for in this Act.

SEC. 7. DUTIES OF RETAILERS TO ENSURE ACCESS TO ORAL BIRTH CONTROL FOR 
              USE WITHOUT A PRESCRIPTION.

    (a) In General.--Any retailer that stocks oral birth control for 
routine, daily use that is approved by, or otherwise legally marketed 
under regulation by, the Food and Drug Administration for use without a 
prescription may not interfere with an individual's access to or 
purchase of such birth control or access to medically accurate, 
comprehensive information about such birth control.
    (b) Limitation.--Nothing in this section shall prohibit a retailer 
that stocks oral birth control for routine, daily use from refusing to 
provide an individual with such oral birth control that is approved by, 
or otherwise legally marketed under regulation by, the Food and Drug 
Administration if the individual is unable to pay for the birth 
control, directly or through insurance coverage.
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