HHS Secretary Robert F. Kennedy Jr. tells FDA to review safety of mifepristone – The Wisconsin Independent

Report on the U.S. Food and Drug Administration’s Review of Mifepristone and its Alignment with Sustainable Development Goals

Introduction and Context

The U.S. Department of Health and Human Services has directed the Food and Drug Administration (FDA) to conduct a safety review of the medication mifepristone. This directive follows the publication of a non-peer-reviewed report by the Ethics and Public Policy Center (EPPC), a think tank involved with Project 2025. Given that mifepristone was used in 63% of all U.S. abortions in 2023 and has been FDA-approved for 25 years, this review has significant implications for several United Nations Sustainable Development Goals (SDGs), particularly those concerning health, gender equality, and institutional integrity.

Assessment of SDG 3: Good Health and Well-being

The review directly impacts SDG 3, which aims to ensure healthy lives and promote well-being for all at all ages. Specifically, it relates to Target 3.7: ensure universal access to sexual and reproductive health-care services.

• Established Safety Record: Mifepristone has a 25-year history of safe and effective use by 7.5 million people in the United States. Decades of peer-reviewed, scientific evidence confirm its safety, with numerous studies finding serious complication rates of less than 1%.
• Challenge to Evidence-Based Health Policy: The EPPC report, which was not peer-reviewed or published in a medical journal, claims a serious adverse event rate of nearly 11%. Medical experts, including the president of the American College of Gynecology, have stated this report “manipulates data to drive a myth that medication abortion isn’t safe,” challenging the foundation of evidence-based public health.
• Access to Essential Healthcare: Medication abortion provides a private and effective method for ending a pregnancy, contributing to the spectrum of reproductive health services essential for achieving SDG 3. Questioning its safety based on non-scientific reports threatens access to this critical healthcare component.

Analysis of Impact on SDG 5 (Gender Equality) and SDG 10 (Reduced Inequalities)

Restricting access to mifepristone would create significant setbacks for gender equality and exacerbate existing health disparities, undermining progress on SDG 5 and SDG 10.

1. Reproductive Autonomy and Gender Equality: SDG Target 5.6 aims to ensure universal access to sexual and reproductive health and reproductive rights. Access to safe abortion methods is a fundamental aspect of bodily autonomy and is critical for achieving gender equality, allowing individuals to control their reproductive lives.
2. Role of Telehealth in Reducing Inequality: Since the 2022 reversal of Roe v. Wade, telehealth has become the sole method for accessing abortion care in states with bans. This service is vital for overcoming geographic and economic barriers, directly addressing SDG 10 (Reduced Inequalities).
3. Risk of Increased Disparities: Experts suspect the FDA review is intended to justify reimposing in-person dispensing requirements, thereby eliminating telehealth access. Such a policy change would disproportionately harm individuals in states with abortion bans, low-income communities, and rural populations, widening the gap in healthcare access and outcomes.

Examination of SDG 16: Peace, Justice, and Strong Institutions

The nature of the review raises concerns about the integrity of public health institutions, a key component of SDG 16, which promotes effective, accountable, and inclusive institutions at all levels.

• Politicization of Scientific Bodies: The directive from the HHS Secretary, a political appointee without medical qualifications, to single out a specific drug for review based on a political think tank’s report is highly unusual. This action risks undermining the scientific independence and evidence-based mandate of the FDA, conflicting with SDG Target 16.6.
• Disregard for Scientific Standards: The reliance on a non-peer-reviewed report over decades of rigorous scientific data represents a departure from standard epidemiological principles. Critics note the EPPC report’s methodological flaws, such as defining any emergency room visit as a “serious adverse event” and using a non-standardized definition of “hemorrhage.”
• Threat to Institutional Trust: Using “junk science” to drive regulatory review erodes public trust in scientific and governmental institutions, jeopardizing their ability to protect public health effectively.

Sustainable Development Goals (SDGs) Addressed in the Article

1. SDG 3: Good Health and Well-being

   • The article’s central theme is the safety, efficacy, and accessibility of mifepristone, a medication used for abortion. This directly relates to public health, patient well-being, and access to essential healthcare services. The debate over the drug’s safety review by the FDA and the conflicting data on adverse events are core to ensuring good health outcomes for individuals seeking reproductive care.

2. SDG 5: Gender Equality

   • The discussion on abortion access is intrinsically linked to gender equality. Access to safe and legal abortion is a critical component of women’s reproductive rights and their ability to make autonomous decisions about their bodies and lives. The article highlights how political actions and challenges to the availability of mifepristone, particularly through telehealth, directly impact women’s access to essential healthcare and their reproductive freedom.

3. SDG 16: Peace, Justice and Strong Institutions

   • The article raises significant concerns about the integrity and independence of public institutions, specifically the FDA. Experts quoted in the article suggest that the review of mifepristone is politically motivated, driven by a non-peer-reviewed report from a partisan think tank, rather than by “gold standard science.” This challenges the principle of having effective, accountable, and transparent institutions that operate based on evidence rather than political pressure.

Specific SDG Targets Identified

1. Target 3.7: Ensure universal access to sexual and reproductive health-care services.

   • The article focuses on mifepristone, a key component of medication abortion, which is a fundamental sexual and reproductive health service. The potential for the FDA review to reimpose in-person dispensing requirements and eliminate telehealth prescribing directly threatens universal access, especially for individuals in states with abortion bans who rely on telehealth for care.

2. Target 3.8: Achieve universal health coverage, including access to safe, effective, quality and affordable essential medicines.

   • Mifepristone is presented as a safe and effective essential medicine, used by millions. The debate over its safety, fueled by a report claiming a high rate of adverse events, directly questions its quality and safety. The article emphasizes the importance of telehealth in ensuring access to this medicine, connecting to the goal of universal health coverage.

3. Target 5.6: Ensure universal access to sexual and reproductive health and reproductive rights.

   • The entire conflict described in the article revolves around a service that is central to reproductive rights. The actions to review and potentially restrict access to mifepristone are portrayed as a direct challenge to the ability of individuals to exercise their reproductive rights, particularly after the reversal of Roe v. Wade.

4. Target 16.6: Develop effective, accountable and transparent institutions at all levels.

   • The article questions the effectiveness and accountability of the FDA’s decision-making process. A former FDA associate commissioner is quoted expressing concern that the HHS Secretary is singling out a specific drug for scrutiny based on politics rather than science, undermining the institution’s standard, evidence-based procedures.

Indicators for Measuring Progress

1. Indicators for SDG 3 (Good Health and Well-being)

   • Rate of serious adverse events following medication abortion: The article explicitly discusses this as a key point of contention. The EPPC report claims a rate of nearly 11%, while numerous peer-reviewed studies and the American College of Gynecology state that serious complications occur in less than 1% of patients. This data is a direct measure of the medicine’s safety.
   • Proportion of abortions performed using medication: The article states that in 2023, mifepristone was used in “63% of all abortions performed in the country.” This statistic serves as an indicator of the reliance on and accessibility of this particular healthcare method.
   • Accessibility of services via telehealth: The article implies this as a crucial indicator, noting that telehealth is “the only way that patients in states with abortion bans have been able to access abortion care.” The continuation or elimination of telehealth prescribing is a measure of access to care.

2. Indicators for SDG 5 (Gender Equality)

   • Number of people accessing safe abortion services: The article mentions that the pill has been “used safely and effectively by 7.5 million Americans,” which serves as a cumulative indicator of access to this form of reproductive healthcare over 25 years.
   • Legal and regulatory framework for abortion access: The article implies this through its discussion of the FDA’s role in regulating mifepristone, the potential for reimposing in-person dispensing requirements, and the context of the Supreme Court’s reversal of Roe v. Wade. Changes in these regulations are direct indicators of the status of reproductive rights.

3. Indicators for SDG 16 (Peace, Justice and Strong Institutions)

   • Reliance on peer-reviewed scientific evidence in policymaking: The article strongly implies this as an indicator by contrasting the “gold standard science” and “peer-reviewed studies” with the “new junk science reports” and a study that was “neither peer-reviewed nor published in a medical journal.” The basis for the FDA’s review (whether it’s the former or the latter) is an indicator of the institution’s integrity.

Table of SDGs, Targets, and Indicators

Source: wisconsinindependent.com