Birth control pills could soon be available over-the-counter — a moment that would mark a milestone in a reproductive health landscape shaken by seismic legal and political upheavals this past year.
For the first time, the Food and Drug Administration is weighing whether to allow a daily contraceptive to be sold without a prescription. The agency’s outside experts are set to meet next week to discuss the shift reproductive health advocates and major medical groups have pushed for years. Groups like the American College of Obstetricians and Gynecologists say the Supreme Court’s decision to overturn Roe v. Wade adds urgency to the effort.
The FDA could decide by the end of the summer on the question, which hasn’t ignited a legal or political battle like the abortion pill mifepristone. The opposition has largely emerged from Catholic groups traditionally opposed to birth control in favor of natural family planning methods.
Yet, there are some major questions looming, particularly over how much the pills would cost and whether insurers would cover them free without a prescription. For supporters of the effort, FDA approval wouldn’t be a total win: They are calling on the Biden administration to explicitly state that insurers must cover the costs of the pills.
About the effort: Last July, HRA Pharma submitted the OTC application for Opill, a progestin-only pill. By all accounts, the FDA is proceeding cautiously in its review. The agency postponed a meeting of its outside experts last fall to review more information from the manufacturer. (The FDA declined to comment on Opill, saying it doesn’t discuss pending applications.)
On the other side: Catholic groups critical of the switch have focused in part on alleged safety issues.
“We strenuously oppose the nonprescription availability of Opill,” the United States Conference of Catholic Bishops, National Catholic Bioethics Center, Catholic Medical Association and National Association of Catholic Nurses wrote to the FDA’s outside advisers in November, citing concerns with obtaining the medication before seeing a doctor.
Meanwhile, antiabortion groups are largely staying mum. Asked about over-the-counter birth control, the National Right to Life organization said it “does not take a stance on anything that prevents fertilization.” SBA Pro-Life America said its focus is on “advancing laws that protect unborn children and their mothers from abortion, especially from dangerous mail-order abortion pills.”
The Affordable Care Act mandates insurers cover contraception at no cost. But plans aren’t required to cover items available over the counter, like Plan B, unless a patient has a prescription, according to the Centers for Medicare and Medicaid Services.
While the agency says it encourages insurers to cover over-the-counter contraception free without a prescription, it’s not clear whether the Biden administration will make that a requirement. In a statement, CMS said the agency “remains committed to ensuring broad access to high-quality, affordable, person-centered health care coverage.”
Another unknown: The price. HRA Pharma is unlikely to announce a cost for its nonprescription product until it receives the greenlight from the FDA, though the company has said it’ll offer assistance to people who cannot afford the drug.
For the first time, the Food and Drug Administration is weighing whether to allow a daily contraceptive to be sold without a prescription. The agency’s outside experts are set to meet next week to discuss the shift reproductive health advocates and major medical groups have pushed for years. Groups like the American College of Obstetricians and Gynecologists say the Supreme Court’s decision to overturn Roe v. Wade adds urgency to the effort.
The FDA could decide by the end of the summer on the question, which hasn’t ignited a legal or political battle like the abortion pill mifepristone. The opposition has largely emerged from Catholic groups traditionally opposed to birth control in favor of natural family planning methods.
Yet, there are some major questions looming, particularly over how much the pills would cost and whether insurers would cover them free without a prescription. For supporters of the effort, FDA approval wouldn’t be a total win: They are calling on the Biden administration to explicitly state that insurers must cover the costs of the pills.
The details
The advisory committee meeting begins May 9, which also happens to be the 63rd anniversary of the FDA’s approval of the first birth control pill.About the effort: Last July, HRA Pharma submitted the OTC application for Opill, a progestin-only pill. By all accounts, the FDA is proceeding cautiously in its review. The agency postponed a meeting of its outside experts last fall to review more information from the manufacturer. (The FDA declined to comment on Opill, saying it doesn’t discuss pending applications.)
- Birth control pills are available without a prescription in over 100 countries. Experts say the United States has lagged behind for several reasons: a lack of interest from the pharmaceutical industry, caution by the FDA and past battles over the emergency contraceptive Plan B.
The arguments
Supporters say some of the biggest beneficiaries would be women from rural or low-income areas – disproportionally women of color – who face barriers to obtaining prescription pills. Those obstacles include finding a doctor or other provider, getting to a clinic and finding child care. Both the progestin-only pills and combination pills are deemed safe and effective.On the other side: Catholic groups critical of the switch have focused in part on alleged safety issues.
“We strenuously oppose the nonprescription availability of Opill,” the United States Conference of Catholic Bishops, National Catholic Bioethics Center, Catholic Medical Association and National Association of Catholic Nurses wrote to the FDA’s outside advisers in November, citing concerns with obtaining the medication before seeing a doctor.
Meanwhile, antiabortion groups are largely staying mum. Asked about over-the-counter birth control, the National Right to Life organization said it “does not take a stance on anything that prevents fertilization.” SBA Pro-Life America said its focus is on “advancing laws that protect unborn children and their mothers from abortion, especially from dangerous mail-order abortion pills.”
The cost conundrum
The ease of buying the pill over-the-counter, like any medication, will partly depend on its price.The Affordable Care Act mandates insurers cover contraception at no cost. But plans aren’t required to cover items available over the counter, like Plan B, unless a patient has a prescription, according to the Centers for Medicare and Medicaid Services.
While the agency says it encourages insurers to cover over-the-counter contraception free without a prescription, it’s not clear whether the Biden administration will make that a requirement. In a statement, CMS said the agency “remains committed to ensuring broad access to high-quality, affordable, person-centered health care coverage.”
Another unknown: The price. HRA Pharma is unlikely to announce a cost for its nonprescription product until it receives the greenlight from the FDA, though the company has said it’ll offer assistance to people who cannot afford the drug.
- “The only way that this will be seen as a win for reproductive rights is if this is not just approved but also approved for all ages, at an accessible price and covered by insurance,” said Daniel Grossman, director of the Advancing New Standards in Reproductive Health research program at the University of California at San Francisco.
