Overview
Title
To allow women greater access to safe and effective oral contraceptive drugs intended for routine use, and to direct the Comptroller General of the United States to conduct a study on Federal funding of contraceptive methods.
ELI5 AI
H. R. 8659 is a bill that wants to make it easier for women to get birth control pills without needing a doctor's note, and it also asks a government office to look at how much money the government has been spending on different types of birth control for the last 15 years.
Summary AI
H. R. 8659 aims to improve women's access to safe and effective oral contraceptive drugs available over the counter. It requires the Secretary of Health and Human Services to prioritize and waive fees for certain supplemental applications for contraceptive drugs, ensuring these drugs are accessible to those 18 and older without a prescription. Additionally, the bill calls on the Comptroller General to study and report on federal funding for contraceptive methods over the past 15 years. This includes reviewing funds from various programs like Medicare, Medicaid, and the Indian Health Service.
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AnalysisAI
The "Allowing Greater Access to Safe and Effective Contraception Act," introduced in the House of Representatives, aims to facilitate improved access to oral contraceptives for women. The bill proposes to streamline the approval process for over-the-counter oral contraceptives intended for routine use, excluding emergency contraceptives or drugs approved for induced abortion. Furthermore, the bill requests a study by the Comptroller General on federal funding related to contraceptive methods over the past fifteen years.
General Summary of the Bill
The bill consists of two main sections. Firstly, it proposes a priority review process by the Secretary of Health and Human Services for applications related to over-the-counter oral contraceptives for routine use. This would potentially expedite the availability of these drugs, yet maintains prescription requirements for individuals under 18. Secondly, it directs the General Accountability Office (GAO) to conduct a comprehensive study on federal funding over the last fifteen years toward contraception-related activities, encompassing programs such as Medicare, Medicaid, and others.
Summary of Significant Issues
Several issues arise from the bill's provisions. In Section 2, the over-the-counter availability for individuals under 18 seems contradictory as these drugs would remain under prescription regulations even after priority approval. Moreover, the lack of clarity around the definition of "routine use" and the fee waiver process may lead to confusion and inconsistency in the drug approval process.
In Section 3, the 15-year timeframe poses challenges due to potential shifts in data collection methods and the impact of inflation. Collecting consistent data across varied programs with different reporting standards could lead to inefficiencies or inaccuracies. Additionally, the inclusion of temporary assistance programs traditionally focused on welfare, rather than health or contraception, adds ambiguity regarding the study's scope.
Impact on the Public
The potential impact of this bill on the public is significant. Improved access to contraceptives could contribute positively to public health by reducing unwanted pregnancies and giving women more control over their reproductive lives. However, the lack of clarity in some provisions may inhibit the bill's effectiveness. Ensuring that women under 18 have correct access and understanding how fee waivers will be administered are crucial for the bill's success in expanding access efficiently.
Impact on Specific Stakeholders
For pharmaceutical companies, the bill could offer positive benefits by potentially streamlining the process for bringing certain contraceptives to the over-the-counter market. However, without clear guidelines, they may face challenges in determining eligibility for priority review.
For healthcare providers and pharmacists, the change might require adjustments in how they dispense contraceptives, particularly concerning the regulations for those under 18. Providers may also be involved in navigating and interpreting the data resulting from the GAO study.
Lastly, stakeholders involved in federal health programs may find the task of collecting and reporting historical funding data burdensome. Clarity in requirements and scope will be essential to ensure the study's effectiveness and relevance.
In summary, while the bill holds promise for improving contraceptive access, the unresolved issues and ambiguities must be addressed to fulfill its potential and ensure practicality within the healthcare and pharmaceutical sectors.
Issues
The provision regarding the over-the-counter availability for individuals under age 18 is somewhat contradicting as it subjects the drug to a prescription requirement under section 503(b)(1) even after priority review approval, which can lead to misinterpretation. (Section 2)
The timeframe of 15 years for the GAO study may make it challenging to accurately collect and analyze data on the funding for contraceptive methods due to changes in programs, data collection methodologies, and inflationary effects over time. (Section 3)
The inclusion of multiple programs under various acts, such as the Social Security Act and the Public Health Service Act, could lead to complexity in gathering consistent data due to differing reporting mechanisms and requirements across these programs, potentially resulting in inaccuracies or inefficiencies in the study. (Section 3)
The bill section does not define how the 'fee waiver' process under section 736(a)(1) should be implemented, potentially leading to confusion regarding whether additional procedures or documentation are required, which could delay the process. (Section 2)
The directive to include temporary assistance for needy families under part A of title IV of the Social Security Act might seem ambiguous as it is traditionally more focused on welfare support rather than health and contraception, which might not align with the primary funding intent, leading to potential misallocation of resources. (Section 3)
The language does not specify what constitutes sufficient 'provider training' or 'patient education,' leading to potential ambiguity in what qualifies as reportable funding under those categories, resulting in varying interpretations and inconsistencies in the study findings. (Section 3)
The text does not specify criteria for what constitutes 'routine use' for oral contraceptive drugs, which could lead to ambiguity in determining eligibility for priority review, resulting in inconsistent application and possible legal challenges. (Section 2)
The applicability clause involves dates relative to the enactment of the bill, which may require additional clarification on how to process applications submitted around the enactment date, leading to administrative challenges and inconsistencies in implementation. (Section 2)
Sections
Sections are presented as they are annotated in the original legislative text. Any missing headers, numbers, or non-consecutive order is due to the original text.
1. Short title Read Opens in new tab
Summary AI
The first section of this bill states that the official title of the legislation is the “Allowing Greater Access to Safe and Effective Contraception Act.”
2. Supplemental applications for over-the-counter contraceptive drugs Read Opens in new tab
Summary AI
The section mandates that the Secretary of Health and Human Services give priority review to applications for over-the-counter oral contraceptives for routine use, excluding emergency contraceptives and drugs approved for abortion, and waive the application fee for such cases. It also states that individuals under 18 would remain subject to prescription requirements even if the drug is approved for over-the-counter use for those 18 and older.
3. GAO study and report on Federal funding of contraceptive methods Read Opens in new tab
Summary AI
The General Accountability Office (GAO) is required to study and report to Congress on the amount of federal funds allocated for various contraception-related activities over the last 15 years. This includes funding through programs like Medicare, Medicaid, the Indian Health Service, and others listed in the text.