Three blister packs of birth control pills on a pink background.

Opill’s FDA Approval: Implications for Pharmaceutical Regulation and Access to Care

By James René Jolin and Susannah Baruch

On July 13, 2023, the United States Food and Drug Administration (FDA) approved Opill (norgestrel) as the first daily oral contraceptive available for non-prescription use in the U.S. While the timeline for availability and price of Opill will ultimately be set by its manufacturer, Perrigo, this recent move represents a significant step forward in improving access to contraceptive health care. Indeed, shortly after Opill’s approval, the American College of Obstetricians and Gynecologists described the FDA’s decision as “a critically important advancement in the accessibility of reproductive health care.”

In response to this development, Petrie-Flom Center intern James René Jolin and Executive Director Susannah Baruch sat down to discuss its legal, regulatory, and public health implications. This interview has been edited for brevity and clarity.

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Image of a pile of contraceptive pills.

The Contraceptive Coverage Mandate Is Urgently Needed

By Gregory Curfman

Within the coming months, the constitutional right to abortion, which has been in place for nearly 50 years, is likely to be overturned.

In this light, it is more crucial than ever that women have unfettered access to contraception at no charge. Accordingly, the Biden Administration should act now to return the Affordable Care Act’s (ACA) contraceptive coverage mandate to its status originally intended by Congress in 2010.

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Mexico City 03082021 Feminist march against gender violence, March 8 in Mexico thousands of women protest in the streets for safety and better living conditions, using banners.

Strengthening Global and National Governance for Gender Equality in Health Emergencies

By Anna Coates

An international instrument on pandemic preparedness and response opens a much-needed space to highlight the centrality of gender inequality considerations in health emergency responses.

With an eye to inclusive governance, investment in gender expertise, and strengthening existing normative mechanisms and architecture for gender equality at global and national levels, a new intergovernmental instrument offers an opportunity for future health emergency preparedness and responses to meaningfully contribute to gender equality.

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A range of contraceptive methods: DMPA, vaginal ring, IUD, emergency contraceptive, contraceptive pills.

Connecting the Dots: Reproductive Justice + Research Justice = Health Justice

By Monica R. McLemore

I believe that together, reproductive justice and research justice should result in health justice.

I am choosing to focus on research because it is the evidence base that is foundational to clinical care provision and because teaching is generated by research.

Thus, research serves as one root cause of harm associated with clinical care and teaching, and a potential barrier to realizing health justice, which has been outlined as a comprehensive approach to resolve the social determinants of health and develop jurisprudence toward health equity. Research justice is critical to the conceptualization, development and implementation of these measures.

However, the law cannot establish health justice without reproductive justice, at least not for pregnant-capable people. Reproductive health, rights, and justice have been the proverbial canaries in the coal mine when considering the loss of bodily autonomy and human rights.

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Abortion rights protest following the Supreme Court decision for Whole Women's Health in 2016

How Social Movements Have Facilitated Access to Abortion During the Pandemic

By Rachel Rebouché

Before the end of 2021, the U.S. Food and Drug Administration (FDA) will reconsider its restrictions on medication abortion. The FDA’s decision could make a critical difference to the availability of medication abortion, especially if the Supreme Court abandons or continues to erode constitutional abortion rights.

Under that scenario of hostile judicial precedents, a broad movement for abortion access — including providers, researchers, advocates, and lawyers — will be immensely important to securing the availability of remote, early abortion care.

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Person typing on computer.

COVID-19 and the New Reproductive Justice Movement

By Mary Ziegler

The COVID-19 pandemic has transformed advocacy for reproductive rights and reproductive justice in what previously had been called an endless, unchanging, and intractable abortion conflict.

The pandemic — and the stay-at-home orders it required — finally shifted the movement’s focus to abortion access, rather than abortion rights, as exemplified by its emphasis on medication and telehealth abortion.

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abortion protest outside supreme court.

The COVID-19 Pandemic Reveals the Stakes of the Campaign Against Abortion

By Mary Ziegler

Once again, we’re talking about whether abortion counts as health care. The COVID-19 pandemic has sparked new efforts to limit access, from the government’s unwillingness to lift in-person requirements for medication abortion to the introduction of stay-at-home orders blocking access altogether. The campaign to frame abortion as a moral, not medical, issue began decades ago. The pandemic has revealed the broader stakes of this campaign — and what it might mean for access to care well after the worst of the pandemic is behind us.

For antiabortion leaders, there are obvious strategic reasons to insist that abortion is not health care. The stigma surrounding abortion is real and durable. Notwithstanding recent increases, many obstetric programs do not provide comprehensive abortion training (if they provide any training at all). A 2020 study in Plos One found that a majority of patients believed that they would be looked down upon “at least a little” for having had an abortion. This perceived stigma affects those refused abortions — and causes longer-term adverse mental health outcomes. Stigma has long been an effective tool for the antiabortion movement. The pandemic has done nothing to change that.

But, put in historical context, today’s effort to treat reproductive services as unessential means much more. That campaign is part of a broader agenda to undermine the idea of an autonomy-rooted abortion rights — and lay the groundwork for overturning Roe v. Wade.

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Image of a pile of contraceptive pills.

The Contraceptive Mandate Takes Another Hit  

By Elizabeth Sepper and John Aloysius Cogan, Jr.

Known for his national injunctions of federal legislation, district court judge Reed O’Connor is at it again. In DeOtte v. Azar [PDF], he issued a permanent injunction granting religious exemptions to two nationwide classes that object to the Affordable Care Act’s contraception mandate. Judge O’Connor’s decision is notable for both its expansion of religious exemptions—in contradiction of eight out of nine appellate courts to consider the issue—and its casual disregard for the realities of health insurance markets.

DeOtte is the latest in a series of lawsuits pitting the Religious Freedom Restoration Act, which bars the federal government from substantially burdening a person’s exercise of religion, against the ACA’s mandate that insurance plans cover FDA-approved contraceptives.

Initially, under the mandate, churches were exempt and religious non-profit employers—like hospitals and universities—received an accommodation. So long as non-profits gave notice of their objection, their plans could exclude contraception. Their employees then would receive contraception coverage through the insurance company or health plan administrator. In 2014, the Supreme Court extended the accommodation to closely held for-profit corporations in Burwell v. Hobby Lobby, Inc. Read More

Institutional Conscience, Individual Conscience

The debate over compulsory coverage for contraception rages on, with Notre Dame changing their policy on coverage for birth control again under Trump executive order allowing them to do so. The university had initially claimed that a requirement mandating them to provide contraceptive coverage was a burden on its exercise of religion, and discontinued coverage last October, before quickly reversing course after a protracted outcry from students, faculty and staff. Over 17,000 people are currently covered by the institution’s insurance plan. The university’s current position is to cut coverage for birth control that the university considers to be inconsistent with Catholic teachings; continuing coverage for ‘simple contraception’ while discontinuing coverage for contraception that ‘kills a fertilized egg’.  

The Affordable Care Act required that insurers cover the cost of contraception without any out-of-pocket costs by the claimant, with exemptions for houses of worships and closely-held for-profits, with the proviso that organisations that wished to avail of the exemption must notify the federal government, who would then contract directly with the insurer to provide unimpeded access to birth control for employees and their dependents. Under Trump administration rules, the exemption has been expanded to include non-profit organizations and for-profit companies, including public corporations, and a separate HHS rule allows similar moral objections for most institutions.

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Why Are So Many American Women Dying in Childbirth?

By Clíodhna Ní Chéileachair

In November Serena Williams, indisputably one of the greatest – if not the greatest – tennis player in history gave birth to her daughter by emergency Caesarean section. After the surgery, Williams reported to an attending nurse that she was experiencing shortness of breath and immediately assumed she was experiencing pulmonary embolism. The star athlete has a history of blood clots and had discontinued blood thinners before the surgical delivery. Contrary to William’s requests for a CT scan and blood thinners, medical staff assumed that pain medication had made her confused. A later CT scan confirmed Williams’ self-diagnosis. Stripping out the fact of Williams’ identity turns this near-miss into a terrifyingly common story in US maternal care, albeit one with a happier ending than many. The global trend in maternal death rates – the rate of women dying in childbirth and post-childbirth – has rapidly decreased over the past 15 years. At the same time, the US, despite recording one of the highest per capita income levels in the world, has one of the highest maternal mortality rates in the developed world.

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