For Desiree, a 26-year-old home health aide who works as a bartender on weekends, life is a constant scramble. She and her boyfriend, who live in Tucson and have a 3-year-old daughter, want more children – but only after she goes to nursing school and they buy a house.
“We need more time to get settled,” said Desiree, who spoke on the condition that she be identified by only her first name to discuss private matters.
Recently, Desiree’s birth control prescription ran out. To get a new one, she has to wait at least a month to see a doctor. She and her partner are taking steps to avoid a pregnancy, but “it would be way, way easier” if she could just buy pills over the counter, Desiree said.
That day may be coming. For the first time, the Food and Drug Administration is weighing whether to allow a daily contraceptive to be sold OTC – over the counter. Next week, the agency’s outside experts are expected to meet to discuss an OTC request from a French company that makes a contraceptive called Opill. Birth control pills are available in more than 100 countries without a prescription.
The FDA could decide on the application by the end of the summer. If it approves the OTC switch, it would mark the latest milestone in a reproductive health landscape shaken by seismic legal and political upheavals during the past year.
This month marks the 63rd anniversary of the FDA’s approval of the first birth control pill – a move that transformed American society. Many consider the arrival of the pill, promoted for decades by activists determined to give women greater sexual and economic freedom, to be a landmark moment in the 20th century.
Now, a year after the Supreme Court overturned Roe v. Wade, which guaranteed the nationwide right to abortion, the pill should immediately be made more widely available, say reproductive health advocates and medical groups, including the American College of Obstetricians and Gynecologists and the American Medical Association. About 46 percent of U.S. pregnancies are unintended, according to a new study by the Guttmacher Institute, a U.S. research organization that supports reproductive rights.
“We are all living in a post-Roe world where access to contraception is more important than ever,” said Raegan McDonald-Mosley, CEO of Power to Decide and a member of the steering committee of the Free the Pill coalition, an advocacy group. “It creates a new urgency to make contraception as available and accessible as possible.”
Some of the biggest beneficiaries of OTC contraceptives would be people of color and members of other underserved communities who face a constellation of barriers in getting access to prescription birth control pills, public health experts say.
Those obstacles include finding a doctor or other provider, getting to a clinic and arranging child care during doctor’s visits, as well as privacy concerns, said Krishna Upadhya, a pediatrician and adolescent medicine specialist who is vice president of quality care and health equity at Planned Parenthood Federation of America.
“Young people certainly face those barriers,” as do Black, Latino, and LGBTQ people, Upadhya said.
Rural communities, facing waves of hospital and pharmacy closures amid a national maternal mortality and morbidity crisis, also need much better access to birth control, said Brian E. Dixon, director of public health informatics at the Regenstrief Institute and Indiana University Richard M. Fairbanks School of Public Health.
“Pregnancy takes a big toll,” Dixon, who researches rural women’s health, said. “Women who are not seeking to be pregnant should have the ability to prevent it.”
Meanwhile, the prospect of an OTC pill has not set off political and legal battles akin to those ignited by one of the abortion drugs, mifepristone, which is the target of a lawsuit by antiabortion medical organizations and doctors.
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.” Susan B. Anthony 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 OTC application for Opill was submitted last July by HRA Pharma, a Paris firm owned by Perrigo, a giant Dublin-based generic drugmaker. The drug was cleared decades ago under a different name for prescription use but was eventually taken off the market by Pfizer for commercial reasons. HRA Pharma acquired it in 2014 and, in recent years, has been working closely with Ibis Reproductive Health, a Cambridge, Mass., research group that heads Free the Pill.
“We thought there was a need to give women more access and to go for a switch,” said Frédérique Welgryn, Perrigo/HRA Pharma global vice president for women’s health.
By all accounts, the FDA is being extremely cautious in its review. It postponed a meeting of its outside experts, scheduled for last fall, to review more information from the manufacturer. The FDA declined to comment on Opill, saying it does not discuss pending applications.
For proponents of a nonprescription birth control pill, FDA approval would be a significant but not complete win. To ensure access by adolescents, they say, the product must be reasonably priced and available without age restrictions. In addition, they are calling on the Biden administration to explicitly state that insurers must cover the costs of OTC birth control pills.
“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.
The Affordable Care Act requires insurers to cover contraception for free. But plans aren’t required to cover items available over the counter, including emergency contraception sometimes called the “morning after pill,” unless a patient has a prescription, according to the Centers for Medicare and Medicaid Services. That means an OTC birth control pill could still be out of reach for many, depending on the price.
While the agency says it encourages plans to cover OTC contraception for free when someone doesn’t have a prescription, it’s not clear whether the Biden administration could require insurers to do so. In a statement, CMS said the agency “remains committed to ensuring broad access to high-quality, affordable, person-centered health care coverage.”
Some states are adopting a more aggressive posture. Several are requiring the insurance companies they regulate to cover contraceptive products sold without a prescription, according to the Guttmacher Institute. In the meantime, people who want to ensure coverage of their pills can still use one of the many prescription products available.
HRA Pharma is unlikely to announce the price for its nonprescription product until receiving OTC approval from the FDA. The company has said it will offer assistance to people who cannot afford the drug.
There are two main kinds of birth control pills. One contains only progestin, a synthetic form of the natural hormone progesterone. The other contains progestin and a synthetic version of the hormone estrogen.
Opill, which is a progestin-only pill, prevents pregnancy by suppressing ovulation and thickening the mucus in the cervix, preventing sperm from entering the uterus. Progestin-only pills are more popular in Europe than in the United States, where most pills are the combination type.
Both kinds of pills are safe and effective, although the combination pill has more “contraindications” – meaning people with certain medical conditions should avoid it.
Neither birth control pill is recommended for women with a history of breast cancer. Women who are cigarette smokers and older than 35, and those with high blood pressure, are urged to avoid combination pills – which also have been linked to extremely rare blood clots. Progestin-only pills can result in occasional bleeding between menstrual periods, and users are urged to take them at about the same time every day to ensure maximum protection.
For the FDA, drugmakers seeking to sell their products without a prescription must provide evidence that consumers can understand the label and use the medication safely without a doctor’s supervision. The agency has approved over-the-counter status for dozens of drugs, including the opioid-overdose treatment Narcan, the heartburn drug Nexium, and the allergy medication Claritin.
The emergency contraceptive Plan B, which is designed to prevent pregnancy after unprotected sex, was approved by the FDA for over-the-counter sale in 2006, seven years after being cleared for prescription use. But an age restriction on the OTC version spurred political and legal battles until 2013 when the age rule was finally dropped.
Many of the advocacy efforts involving Opill arose out of frustration stemming from previous administrations’ handling of Plan B, said Dana Singiser, co-founder of the nonprofit advocacy group Contraceptive Access Initiative. She wrote in Stat, a medical news site, that Plan B became ensnared in “endless ‘pink tape’ – the extra hurdles that women’s products must clear as a result of societal bias.”
Cadence, a small pharmaceutical company in Oakland, Calif., has said it is planning to ask the FDA for permission to sell a combination birth control pill over the counter. But that effort is years behind HRA Pharma.
Because more health conditions make combination pills inappropriate for some people, Cadence has developed a technology-assisted label, consisting of a series of questions, to help consumers determine whether the product is right for them, according to Samantha Miller, the company’s co-founder and co-CEO.
Opposition to OTC birth control has emerged largely from Catholic groups that have traditionally opposed birth control in favor of natural family planning methods that rely on tracking a woman’s cycle, and fertility, throughout the month. Catholic groups that oppose OTC status focus, in part, on safety issues.
“We strenuously oppose the non-prescription availability of Opill,” the U.S. 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.
Tim Millea, chair of the Catholic Medical Association’s healthcare policy committee, noted a recent study suggested there is an increased – albeit extremely small – risk of breast cancer for users of hormonal birth control and said patients should be required to see their doctor at least once a year to check for risk factors.
“The convenience of over-the-counter availability is going to be more than outweighed by the risk of missing things that could be caught early,” Millea said.
Victoria Nichols, project director for Free the Pill, said in a statement that the study cited by Millea did not “draw a causal link” between hormonal contraception and breast cancer but did provide important information for people considering what contraceptive method to use.
Female sterilization is the most common form of contraception in the United States, but the pill is the most popular form of reversible birth control.
White women use the pill at about twice the rate of Black and Hispanic women, federal researchers found. Women who are Black, Hispanic, and under 30 are less likely to use any method of contraception, according to researchers.
Beau Nelson, a sophomore at Williams College in Massachusetts and a member of Advocates for Youth, an advocacy group, takes the pill to regulate menstrual periods and reduce pain. But Nelson can’t get the drug now because their doctor, who practices in their hometown of Sarasota, Fla., won’t renew the prescription until Nelson comes in for an appointment, and Nelson is tied up at school.
When Sriha Srinivasan, a senior at the University of California at Los Angeles, told her mother she was going to join the campaign for OTC status for birth control pills, her mother was surprised to hear oral contraceptives were not available over the counter in the United States. In her mother’s native India, women could just go to the drugstore and buy them, Srinivasan said.
Women with little access to health care might benefit most from the availability of an OTC pill. Georgia Democratic Sen. Kim Jackson, an Episcopal priest who runs a program for homeless people near Atlanta, said many of the women she helps do not have regular access to a physician.
“The women often are quite transient, homeless, engaging in survival sex work, so having access to OTC contraception would be incredibly helpful for them,” she said, adding that she believes such a change would reduce the number of abortions.
Nonprescription birth control pills have been available in Asia and Latin America for years. The United States has lagged, experts say, for several reasons: a lack of interest by the pharmaceutical industry, caution by the FDA, the stigma surrounding women’s reproductive health issues, and the battle involving Plan B.
“It became such a big political fight that I think it scared off pharmaceutical companies,” UCSF’s Grossman said. “They saw they could do all this investment and research and still there could be political opposition to derail the whole project.”
Leah Dolan, a 32-year-old mother with three children under age 8, said she uses an intrauterine device – IUD – for birth control. But she would consider switching to an OTC pill for convenience.
“Time is everything to a parent,” said Dolan, who lives in Phoenix. She said she’s fortunate to be able to drop her children off at her in-laws when she has to go to the doctor, but “with three little kids, it is hard to get out of the house. You have to pack 1,000 things.”
Dolan supports an OTC pill for another reason: “Women are just getting tired of other people deciding what is healthy and good for them, especially concerning their sex lives.”
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