An over-the-counter version has long been called for, but it could soon be available if a group of practitioners and advocates have their way.
by Meredith Melnick
July 07, 2010
When Kelly Blanchard advocated to make oral contraceptives over the counter in a New York Times op-ed two weeks ago, she represented a decades-long movement among clinicians, researchers, and women’s-health advocates to remove prescriptions as a barrier to pill access. As early as 1993, Charlotte Ellertson—founder of Ibis Reproductive Health, of which Blanchard is now president—made a similar argument against the prescription status of oral contraceptives in the American Journal of Public Health.
Now a group of health workers and advocates are taking advantage of a mounting body of research that shows the pill could be safe for nonprescription use. They hope to have a proposal before the FDA within the year and an over-the-counter pill available in five years. And though their work focuses on female reproductive care, it offers a glimpse into what the future of American health care and medication could be.
Members of the Oral Contraceptive Over-the-Counter Working Group, a women’s-health clinical and research institution funded by the Hewlitt Foundation and administered by Ibis Reproductive Health, believe that prescription-only access to birth control is patronizing to women, limits contraceptive freedom, and is ineffective against intractably high teen-pregnancy rates. Teenagers are particularly vulnerable to access problems because it is harder for them to get to a doctor without a parent’s help. Almost 20 percent of sexually active teens who do not want to become pregnant are not using contraceptives, according to the Guttmacher Institute. And teenage girls who do not use contraception during their first sexual experience are twice as likely to become teen mothers as their counterparts who use protection.
“I think we see a range of problems with access today; clearly there are economic barriers to access,” says Amy Allina, program and policy director of the National Women’s Health Network and a member of the working group. “But there are also barriers that have more to do with the logistics of insurance, or the policy at the doctor’s office.”
To date, the FDA has never approved an over-the-counter drug that is a “chronic use” medication—a drug taken daily for an unlimited amount of time. Though people use over-the-counter drugs such as aspirin on a daily basis, they are not technically approved for such use.
The majority of the market in oral contraceptives is in “combined” pills, containing both synthetic estrogen and synthetic progesterone. The estrogen elevates the risk of stroke, heart attack, and blood clots, but it is also responsible for clearing up acne, mitigating cramps, and lessening flow. Because of these secondary benefits, combined pills are more marketable to the general public and favored by many women.
The working group is hoping to bring a progestin-only pill or “mini-pill” to the over-the-counter market. It helps that this synthetic hormone already has an over-the-counter application: emergency contraception. Plan B and Next Choice (FDA-approved since 2006), as well as the recently committee-approved Ella, all consist of progestin, a synthetic form of the hormone progesterone.
The mini-pill is typically used by women who are lactating or who have a higher risk of stroke or heart attack, such as smokers and women over 35. Because it has a lower risk of negative side effects, it might be safer to use without a doctor’s input. “The FDA would consider applications to switch oral contraceptives from prescription to nonprescription marketing status,” says Shelly Burgess, an FDA representative. “Companies interested in marketing an oral contraceptive as a nonprescription product would need to provide data to demonstrate that the proposed oral contraceptive can be used appropriately and safely by consumers without the input of a health-care provider.”
That last bit usually means a potentially expensive and time-consuming doctor’s visit as well as an invasive pelvic exam. The questions are: Is the pill safe to use without a doctor’s examination? And will women still get cancer screening if they don’t have to go to their gynecologist for a pill pack?
And should that matter? “Holding birth control hostage until women have had a pelvic exam is a paternalistic attitude to women’s health,” says Dr. Daniel Grossman, a senior researcher at Ibis and an active member of the group. “The Pap smear is for cancer screening, not contraception, and we shouldn’t spread misinformation by linking the two.”
Until recently, family-planning centers that received federal funds followed the American College of Obstetricians and Gynecologists guidelines to perform a pelvic exam and Pap test as part of each appointment to address family planning. New guidelines suggest that women with two consecutive normal Pap smears need examinations only every two to three years, but many clinics continue to follow the outdated norm.
“At the moment, gynecologists are gatekeepers, insisting on regular vaginal exams that are really unnecessary,” agrees a senior researcher at a university medical school who did not want to be named for fear of upsetting colleagues in the obstetrics and gynecology department. “If the control is transferred to the women themselves, that would amount to a loss of revenue [for gynecologists], and they’re going to fight it.”
A 2006 study in the journal Contraception found that 68 percent of women surveyed wanted an over-the-counter option, with interest highest for women who were uninsured. But women on federal programs like Medicaid could run into problems. “When any medication is offered over the counter, it becomes unaffordable for women whose insurance will not pay for an over-the-counter medication,” says Dr. Vanessa Cullins, vice president for medical affairs of the Planned Parenthood Federation of America.
When Plan B transitioned from a prescription to an over-the-counter drug, its cost skyrocketed. Advocates of the pill’s shift to over the counter are currently looking into ways to keep costs low. One strategy is pairing up with an off-brand production plant. “We could make safe, effective birth-control pills for pennies,” says Dr. Susan Harlap of the NYU School of Medicine, who is not affiliated with the working group. “Their low cost in many developing countries shows that pills are outrageously expensive here, and they needn’t be.”
But the actual cost of the pill isn’t the only consideration for low-income communities. Women who are more likely to have complications from it also tend to be from lower-income communities: poor women have chronic conditions such as cardiovascular disease and obesity in higher numbers, and are also more likely to smoke. Furthermore, a 2008 study in the journal Obstetrics & Gynecology of potential contraceptive users revealed that more highly educated women tended to be better at self-screening. “We tend to prioritize the needs of the group that is more marginalized, that has bigger barriers to health care in general,” says Amy Allina about her organization’s consideration of over-the-counter pills. “It pushed us toward the side of saying we don’t really think this is going to be an advance for the women we are most concerned about.”
Evidence from countries where birth control is available without a prescription goes against these arguments: they do not have higher instances of at-risk women taking pills. Further, researchers in Mexico found that women who buy pills directly from pharmacies often have greater understanding of the contraindications than women who visit clinics.
And evidence suggests that there is no harm done to cancer screening either: a two-year pilot program of pharmacy access to hormonal birth control in Washington state revealed that 98.6 percent of the women who were getting their pills over the counter had had a pelvic examination within the previous 24 months.
“Now, with health-care reform, that balance has shifted,” says Allina. “We see that [low-income] women are going to be able to get access to health services in other ways. It makes us less concerned about some of the unintended consequences to vulnerable populations.”
Meredith Melnick is a freelance journalist in New York City.