FDA Legalizes Nonprescription Birth Control, but Legal Challenges Await

Health & Gender Policy Brief #81 | By: Geoffrey Small | July 28, 2023
Photo taken from: pink.pharmaintelligence.informa.com

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Unintended Pregnancy in the United States

On July 13th, the FDA approved nonprescription birth control pills for use in the United States. Opill, generically referred to as norgestrel, is a progestin-only oral contraceptive that will be available for purchase at drug stores, grocery stores, convenience stores, and online. Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research, stated that the approval “marks the first time a nonprescription daily oral contraceptive will be an available option for millions of people in the United States.” HRA Pharma, recently acquired by Perrigo Company plc, applied for norgestrel to be switched to non-prescription after it met FDA requirements with studies that showed the drug can be “used by consumers safely and effectively, relying only on the nonprescription drug labeling without any assistance from a health care professional.” The approval is a significant victory for reproductive rights, as recent Supreme Court rulings have stripped U.S. citizens of universal access to abortions. However, experts are wary of the legal challenges that may follow the FDA approval. Exploring recent Supreme Court decisions may help the public understand the future of nonprescription birth control.

Policy Analysis 

According to the FDA, “Almost half of the 6.1 million pregnancies in the U.S. each year are unintended. Unintended pregnancies have been linked to negative maternal and perinatal outcomes, including reduced likelihood of receiving early prenatal care and increased risk of preterm delivery, with associated adverse neonatal, developmental and child health outcomes.” Despite this data, reproductive rights have been under siege since the recent infamous Supreme Court ruling that dismantled Roe v. Wade and left the legality of abortion procedures to be determined by the states. 

Many experts also point to the recent challenges of mifepristone, an abortion pill, that could set a precedent for nonprescription birth control. On April 21st, the Supreme Court blocked a lower court decision to ban the FDA-approved drug while lawsuits are challenging the agency’s recent sanctioning of ordering abortion medication online. The ruling doesn’t mean the decision is final. The justices left the decision to ban mifepristone in the hands of the 5th U.S. Court of Appeals. Justice Matthew Kacsmaryk, a Texas U.S. District Judge appointed by the Trump Administration, issued a national ban on April 7th arguing that the approval of the drug 23 years ago was not properly executed. However, Judge Thomas O. Rice in Washington issued a contrary ruling to expand the use of mifepristone minutes after Kacsmaryk’s ruling. Also, The 5th U.S. Circuit Court of Appeals partially limited Kacsmaryk’s decision, as the statute of limitations to challenge the approval passed long ago. Legal experts speculate that the mifepristone decision will almost certainly end back up in the Supreme Court during the next term, because the 5th Circuit still needs to inevitably rule on the lawsuits challenging the drug. 

Lawsuits, backed by anti-reproductive rights groups, for the recent FDA-approval of nonprescription birth control are all but certain to make their way through the federal courts. The mifepristone legal battle is not over and may help determine legal precedents for over-the-counter drugs, like Opill. Organizations like the ACLU are challenging abortion abolitionist legal efforts in the United States. Donating to their organization can help protect reproductive rights from these challenges.


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