FDA is voting on whether or not to make birth control pills available over the counter in May
Federal regulators will meet this spring to decide whether an over-the-counter birth control pill should be made available to women.
Opill, manufactured by French drugmaker HRA Pharma, could become the first over-the-counter progestin-only birth control pill ever approved in the US.
The Food and Drug Administration will meet in May to discuss the company’s application to make Opill, a daily birth control pill that can cost up to $50 per pack without insurance, an over-the-counter drug available without a prescription.
The company first filed the request last summer in the weeks following the Supreme Court’s decision to revoke the federal guarantee of legal and safe abortion. The FDA’s review process can take about a year.
The agency’s decision to deliberate on OTC birth control comes about nine months after Judge Clarence Thomas, who he believes supported the Supreme Court’s decision to remove the federal guarantee on abortion, hinted that legal access to birth control should be reinstated. investigated.
Opill and other oral contraceptives like this have been used safely by millions of women for about 60 years, but the US is an outlier when it comes to making the pills available without a prescription
About three dozen health expert organizations such as the American Medical Association, the American College of Obstetricians and Gynecologists (ACOG), and the American Academy of Family Physicians have been advocating for an over-the-counter birth control pill for years.
Opill and other oral contraceptives like this have been used safely by millions of women for over 60 years, but the US has been an outlier when it comes to making the pills available without a doctor’s prescription.
With recent upheavals in the US legal system over abortion procedures and pills in the US, pressure is mounting on health officials to secure the already tenuous access to contraception for many women.
Two FDA advisory committees — the Over-the-Counter Drugs Advisory Committee and the Reproductive and Urological Drugs Advisory Committee — will meet on May 9 and 10 to consider HRA Pharma’s Rx-to-OTC conversion application for Opill.
Sometimes referred to as the ‘minipill’, Opill contains only progestin, unlike many oral contraceptives which contain both progestin and estrogen.
This is the appeal of the minipill. Since it does not contain estrogen, which increases the risk of blood clotting by a multiple, the progestin-only pills are seen as having a lower risk.
The modus operandi is to thicken the mucus in the cervix, making it difficult for sperm to enter the uterus and fertilize an egg.
Progestogen-only pills do not prevent ovulation as well as combined birth control pills. Therefore, the effectiveness is slightly lower.
Dr. Daniel Grossman, director of the Advancing New Standards in Reproductive Health (ANSIRH) program at the University of California, San Francisco, said: “Oral contraceptives are one of the safest medications I can prescribe to my patients, and the science is clear that they are safe and effective for over-the-counter use. The prescription obligation forms a medically unnecessary barrier that continues to keep healthcare out of reach.’
Many other countries in Latin America and Europe offer access to contraception without a prescription, but the US is lagging behind.
In 2021, the UK approved its first-ever over-the-counter option, also made by HRA Pharma.
When it comes to abortion rights and access to reproductive health care, the US political landscape is fractured and vicious.
Currently, right-wing doctors and political activist groups are battling in court to withdraw FDA approval of mifepristone, one in a cocktail of two drugs that safely and effectively terminates a pregnancy without surgery.
Over-the-counter birth control advocates have been making their case for years, pointing to stark racial and wealth disparities that make access to birth control difficult for minority communities, the young and the poor.
Prescription requirements create barriers for the young and the very poor who do not have health insurance or the financial resources to pay for a doctor and make arrangements around that appointment, such as organizing childcare and transportation.
Over-the-counter birth control available at regular pharmacies would also be a boon to the millions of American women living in so-called birth control deserts — geographic areas that lack funding from federal and state programs, such as Title X and Medicaid, to turn the number low cost family planning clinics needed to serve a particular population.
Victoria Nichols, project leader of the Free the Pill advocacy group said: ‘It is time to release the pill and ensure that those who have long faced the most barriers in care due to systemic inequalities have access to an over-the-counter birth control pill that is affordably priced and covered by insurance.
“The Days of the Current Prescription Requirement — A Barrier Disproportionately Impacting Black, Native, Latina/x, Asian Americans, Native Hawaiian and Pacific Islander Communities, LGBTQ+ People, Youth, People with Disabilities, and Those Who Work to make ends meet – are numbered.’
Access to effective contraception is critical to public health, as about half of all pregnancies are unintended.
The quashing last year in SCOTUS of the 1973 Roe v. Wade decision, which established the federal guarantee for abortion, was not entirely unexpected by abortion advocates and opponents, as a draft opinion had been leaked about a month earlier.
But something about Judge Clarence Thomas’s concurrence sent chills among abortion rights advocacy groups.
Judge Thomas wrote that striking down Roe v. Wade should also open the Supreme Court to review other precedents that could be considered “demonstrably false,” including the right for married couples to purchase and use birth control without government restrictions stemming from the landmark 1965 ruling in Griswold v. Connecticut.