Dr Daniel Grossman
Doctors may soon play much less of a part in prescribing birth control, and many are okay with the reduced role.
In July, HRA Pharma submitted an application to the Food and Drug Administration to sell a progestin-based birth control pill without a prescription in retail pharmacies.
“The fact that this pill is so safe, with such a short list of contraindications, it’s a total no-brainer to figure out whether they are eligible or not,” Daniel Grossman, MD, director of the Advancing New Standards in Reproductive Health program at the University of California, San Francisco, said.
Progestin-only birth control pills have fewer potential risks for women with specific health risks like heart conditions. Estrogen-containing birth control is associated with risk of blood clots.
Approximately 112 countries had some form of nonprescription access to oral contraception in 2015, according to a 2019 analysis published in BMJ Global Health.
Dr Melissa Kottke
“Accessing contraception over the counter could be a game changer for people who experience common barriers to accessing clinics,” said Melissa Kottke, MD, associate professor in the Department of Gynecology and Obstetrics at Emory University in Atlanta, Georgia. “For example, this may help people who can’t get an appointment for several months, who don’t have a nearby clinician for care, who can’t get off work or school to attend a clinic appointment, who do not have transportation, who need additional privacy, [or] who prefer to self-manage their contraception. Expanding contraceptive access is particularly important in a political landscape that is increasingly restrictive for reproductive rights.”
The American College of Obstetricians and Gynecologists, the American Medical Association, and the American Academy of Family Physicians have voiced support for making birth control pills available without a prescription.
Grossman said that while HRA Pharma’s product, Opill, would give women an additional birth control option, it should not replace doctor–patient interactions or consultations about contraception.
Some clinicians are concerned that the over-the-counter pills will not reach patients who need them most. Pharmacy and healthcare deserts disproportionately affect Black and Hispanic women, according to Ebony Jade Hilton, MD, an anesthesiologist at The University of Virginia, Charlottesville.
“As we discuss more things being offered over the counter: COVID-19, meds, birth control, can we actually build those counters in Black and Brown communities?” Hilton wrote on Twitter. “We have both hospital and pharmacy deserts. Options mean nothing without access.”
Hilton also said nonprescription birth control must be affordable.
“For the patients who face the most barriers accessing care, the only way over the counter birth control will make a difference to them is if it’s available at an accessible price,” Hilton said.
Grossman said he expects the FDA’s decision to be controversial, as was the case when the agency approved the emergency contraceptive birth control Plan B for retail settings.
“Initially, there was an age restriction put on emergency contraception when it was being considered for an over-the-counter-switch,” Grossman said. “It ended up taking a lawsuit for the product to become fully available.”
Grossman is a senior advisor to Ibis Reproductive Health, a Boston-area nonprofit that has been running a campaign involving more than 100 reproductive health advocates and related groups. IBIS partnered with HRA Pharma in 2016 to help conduct studies for their FDA application.
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