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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Black and white photograph of the front of the Supreme Court. Pro-abortion protestors stand holding signs, one of which reads "I stand with Whole Woman's Health"

A Brief History of Abortion Jurisprudence in the United States

By James R. Jolin

POLITICO’s leak of Supreme Court Justice Samuel Alito’s draft majority opinion in Dobbs v. Jackson Women’s Health Organization suggests that U.S. abortion rights are on the verge of a fundamental shift.

If the official decision, expected this month, hews closely to the draft, the constitutional right to abortion affirmed in Roe v. Wade (1973), Planned Parenthood v. Casey (1992), and other seminal Supreme Court rulings will disappear.

This brief history of abortion rights and jurisprudence in the United States aims to clarify just what is at stake in this case.

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United States Capitol Building - Washington, DC.

Psychedelic Policy on the Federal Level: Key Takeaways from a Petrie-Flom Center Panel

By James R. Jolin

To navigate the myriad interests and stakes involved in creating federal psychedelic policy, the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School convened a virtual panel discussion with three leading psychedelic policy advocates.

The conversation was situated against the backdrop of the “psychedelics renaissance” in the United States, which has been fueled by a wave of local and state legislation reducing or eliminating the criminal penalties associated with these substances.

Though many localities have made significant strides in addressing the legal questions surrounding psychedelic substances such as psilocybin and dimethyltryptamine (DMT), federal policymakers have not pursued similar initiatives.

Suggestions and considerations for federal psychedelic policy thus formed the substance of the discussion among the panelists:

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Female hand writing signature on the paper document.

How to Construct Better Organ Donation Policy and Achieve Health Equity

By James R. Jolin

The United States is facing an organ donation crisis, with massive gaps between supply and demand.

Per estimates from the Department of Health and Human Services (HHS), over 106,000 Americans are currently awaiting this life-saving medical treatment. Further, the burden of this shortage falls unequally:  in 2020, while approximately 48% of white patients in need of transplants received an organ, only 27% of Black patients secured one.

The stakes are too high to allow the organ donation crisis to proceed in the U.S. without bold intervention. But with many policy options on the table, unresolved ethical concerns, and a patchwork of organ donation laws across the country, the proper path forward is not immediately clear.

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umbrella covering home under heavy rain.

Weathering the Climate Crisis: The Health Benefits and Policy Challenges of Home Weatherization

By James R. Jolin

Weatherization serves as an important yet strikingly neglected tool not only to meet vulnerable communities’ energy needs, but also to combat the negative health effects associated with the climate crisis.

In the United States, households with lower gross income experience higher “energy burdens” — that is, the proportion of a household’s income that is expended to meet energy costs. Indeed, households earning 200% of the federal poverty line spend an estimated 8% of their income on meeting energy costs, as compared to the national median of 3%. Weatherization, the catch-all term for home improvements intended to improve the efficiency of home energy use, is a way to decrease disparate energy costs across socioeconomic classes.

Standard weatherization measures, which include (but are not limited to) repairing and modernizing temperature control systems and installing insulation, reduce the amount of money households need to spend on heating and cooling. In all, weatherization measures save over $280 on average per year, according to the U.S. Department of Energy — a modest but nonetheless important savings.

Crucially, however, weatherization also confers significant health benefits, which are not only ideal in their own right, but also result in further significant financial savings.

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