Ingram Publishing/Newscom
If you live in the United States, you can't obtain birth control pills without a prescription from a doctor. This federal requirement means that the roughly 10.6 million American women on oral contraception must accept regular, invasive, and unnecessary medical care as part of preventing pregnancy.
When the pill first came to the U.S. in 1960, such prescription-only status made some sense. Medical professionals were uncertain how many women would react physiologically. And hormone levels in the first commercially available brand were incredibly high—10,000 micrograms progestin and 50–150 micrograms estrogen, compared to 50–150 micrograms progestin and 20–50 micrograms estrogen on average recently.
But in the nearly 60 years since then, pill formulations have become at least as benign as your average drugstore-aisle offering. Decades of research favors the idea that over-the-counter (OTC) oral contraceptives are safe. They're sold without a prescription in nations across the world, and high-dose emergency contraception has been sold over-the-counter in the U.S. for years. Safety isn't the issue.
Nor is there an obvious political impediment. Republicans believe (at least sporadically) in individual rights and deregulation, and a number of GOP lawmakers have recently supported ending the prescription requirement. Democrats often wax on about a woman's right to take control of her reproductive destiny, and in the past many have pushed for freeing the pill, too. So legalizing OTC contraception should represent common policy ground.
Yet the prescription requirement remains on the books. Why?
For years, blame could be cast on the traditional villains of progressive politics: social conservatives who opposed the pill, the Bible thumpers in the Republican Party who pandered to them, and drug companies with no incentive to do anything that might puncture their profits.
But recently, thanks to Obamacare, Democrats have become the primary impediment to freeing up rules around the sale of contraception. In 2019, it's liberals, not conservatives, who are holding the pill hostage for political gain.
The Case for OTC Contraception
America's paternalistic gatekeeping to contraceptive access is not supported by medical evidence, influential health care groups, or popular opinion.
To put America's prescription rule in context, consider how uncommon it is internationally. Out of 147 countries, the U.S. is among just 45 where a prescription is necessary to obtain birth control pills, according to a study from Daniel Grossman of Ibis Reproductive Health. Polling consistently shows that women favor over-the-counter access. A 2017 survey by the Kaiser Health Foundation found three quarters of women of reproductive age supported "making oral contraceptives available over the counter if the FDA said it was safe and effective."
That support may be especially high among women who previously had an unintended pregnancy or abortion, suggesting that OTC pills could be quite effective in reducing unintended pregnancies.
A 2014 survey from UCSF's Bixby Center focused on members of that group, finding that all but 19 percent were in favor of making birth control pills prescription-free. Only 42 percent said they planned to go on the pill soon, but 61 percent said they would if they could get it over the counter. And around a third of women "who planned to use no contraceptive following their abortion said they would use an over-the-counter pill, as did 38% who planned to use condoms afterward," note the study authors in Perspectives on Sexual and Reproductive Health.
Studies also show that women and teens can effectively self-screen for contraindications to hormonal birth control, that they're prone to err on the side of caution concerning any gray areas, and that doctors aren't always reliable prescribers anyway. Birth control "recommendations of family medicine physicians were found to be inconsistent with CDC guidelines 23% of the time for oral contraceptives (OCs) and 40% of the time for intrauterine devices (IUDs)," according to one study from 2003–06.
Yet under the current status quo, obtaining birth control generally requires a specialized doctor's visit and fee plus a separate trip to the pharmacy, as well as a spate of unrelated tests, since doctors have long made cervical cancer testing and other invasive vaginal examinations a condition of getting contraception. Women must return to the doctor every year or two to maintain the prescription and, in many cases, are barred from obtaining more than a three-month supply of pills at a time.
As a result, a significant number of U.S. women report difficulties in obtaining prescription birth control. A 2016 study found that among U.S. women who had tried to get or refill a prescription, nearly one-third ran into trouble. (Ten years earlier, only one-fourth of women had trouble, according to a 2006 study published in the journal Contraception.) Uninsured women, Spanish-speaking women, and women with less than a high-school education were the most likely to report issues.
"Difficulties included cost barriers or lack of insurance (14%), challenges obtaining an appointment or getting to a clinic (13%), the clinician requiring a clinic visit, exam, or Pap smear (13%), not having a regular doctor/clinic (10%), difficulty accessing a pharmacy (4%), and other reasons (4%)," notes Ibis Reproductive Health.
Affordability presented an obstacle to medical care for about one-quarter of women in the 2017 Kaiser survey. But it was far from the only barrier, with roughly similar percentages citing a lack of time in general or inability to get time off work, and 14 percent citing unreliable transportation or issues with child care.
As these surveys make clear, insurance coverage alone—even coverage that makes pills themselves "free"—is an insufficient condition for expanding birth control access. That's why women's rights advocates have long supported lifting restrictions on access to contraception—a notion that conservatives traditionally opposed.
When Deregulating Contraception Was a Liberal Priority
As recently as a decade ago, it seemed unthinkable that conservatives would ever support over-the-counter access to oral contraception. Despite its appeal to a broad swath of medical professionals and American women on both sides of the partisan divide, the right was dug in.
Democrats' support for selling emergency contraception without a prescription was used in campaigns to smear them as being in favor of minors having sex. Scienceblogs.com ran headlines like "Why the wingnuts hate Plan B." A controversy over whether pharmacists should have the freedom not to fill emergency contraception prescriptions raged. In 2005, at the peak of the emergency contraception debate, the head of the Food and Drug Administration's Office of Women's Health resigned because of how the agency was handling the issue.
But a yearslong fight over the "Plan B" pill exhausted culture-war passions for the issue. Ironically, it was the GOP's effort to maintain abortion restrictions that paved the way for the party to come around on expanding contraception access.
Throughout the George W. Bush presidency and into the Obama administration, fighting for freer contraception was a mainstream liberal priority. During the first dozen or so years of this century, prominent left-of-center groups and lawmakers campaigned hard to get a form of hormonal contraception approved for nonprescription sale.
In November of 2005, NARAL Pro-Choice America, one of the country's most prominent reproductive rights groups, sent out an email complaining that "Despite widespread scientific support, the FDA has repeatedly delayed an application to make the morning-after pill available over the counter." NARAL was pushing a petition from Democratic Sens. Hillary Clinton and Patty Murray, who had urged the FDA to stop stalling and threatening to block then–President Bush's pick to lead the agency until the situation was resolved.
The so-called "morning after pill"—now generally referred to as emergency contraception (E.C.)—can be taken up to several days after sex to prevent pregnancy. Like the daily pills in widespread use by many American women, E.C. interferes with conception by halting ovulation or, if an egg has already dropped, by stopping sperm from getting to it.
Emergency contraception was a cultural flashpoint for more than a decade following the 1999 FDA approval of "Plan B," the brand name E.C. pill, for prescription use. Many religious groups opposed it on the grounds that it could theoretically cause an already-fertilized egg not to implant, rather than just blocking the fertilization of the egg in the first place—making it an "abortifacient." Other conservatives fretted that it could encourage risky sex. Some conservative physicians resisted prescribing it. So it wasn't much of a surprise when a 2003 application to move Plan B to over-the-counter status ran into political resistance.
Yet liberals maintained a steady campaign to change this, and by the end of 2006, Plan B was being sold prescription-free here. At first, sales were from behind a pharmacy counter and only to women ages 18 and up. But after a few rounds of court battles, Plan B became available for nonprescription purchase by women 17 and older, then 16, then 15, and then without point-of-sale restrictions. Finally, in February 2014, the FDA approved unrestricted OTC sale of the generic version of the pills.
Throughout the ruckus about emergency contraception, both the evidence and the political coalition for making regular birth control pills available over the counter was growing. It seemed inevitable that conventional oral contraception—"the pill" three generations of women had been safely taking—would follow the same path as E.C.
Republicans for Contraceptive Access
Under President Barack Obama, the GOP started to talk about birth control pills again. But this time, many sounded a lot like their Democratic counterparts had a few years earlier. Suddenly, it was Republicans—both men and women—who were pushing for easier access to the pill.
In January 2013, Republican Barbara Comstock, then a state representative, and 13 other Virginia lawmakers petitioned Health and Human Services Secretary Kathleen Sebelius to make birth control pills non-prescription. "This is a reform that makes sense, and the Obama administration could quickly move on with bipartisan support," they wrote.
Not long after, a group of male Republicans, including Colorado Sen. Cory Gardner and former Louisiana Gov. Bobby Jindal, also embraced over-the-counter sale. Gardner and former Rep. Mia Love (R–Utah) would go on to sponsor bills meant to kickstart the process.
By the time the 2016 presidential campaign was underway, Republican candidates from Carly Fiorina to Donald Trump were endorsing OTC birth control, with Trump declaring just weeks before the election, "It should not be a prescription."
You might think that would have settled the issue. But just as Republicans were changing their tune, prominent Democrats and groups such as Planned Parenthood started arguing against the idea.
Ilyse Hogue, president of NARAL Pro-Choice America, called Republican endorsements of over-the-counter birth control "a cheap ploy by politicians seeking to distract from their anti-choice records."
"We have to be very careful not to put political pressure on the FDA without going through the regular process," Sen. Murray said, slamming GOP politicians who were pushing for OTC access.
Some flip-flopping can be attributed to simple partisan posturing. Democrats had become comfortable with the Republicans-hate-people-having-sex narrative and weren't about to abandon that playbook. But something else had clearly changed.
That something was the contraception mandate contained in the Affordable Care Act (ACA), the health law enacted in 2010 and colloquially known as Obamacare.
Under the ACA, insurance companies are required to cover certain preventative healthcare services without passing on any upfront costs to the insured. The Department of Health and Human Services (HHS) determined that one such service would be contraception, including all forms commercially available and approved by the FDA. The sorts of exceptions to this requirement that would be available for religious employers became a thorny issue and has been the subject of significant litigation ever since.
Republicans stood with employers who had ethical objections to participating in birth control provision—a move popular among those who believe in freedom of conscience and religious liberty but also one that opened them to political mudslinging that portrayed them as an entire party of religious fundamentalists engaged in a "war on women." Some moderate Republicans saw over-the-counter contraception as a way around this quagmire (and the political problems it posed for them with women voters).
Making birth control available over the counter played well with younger conservatives who still opposed abortion but were less (if at all) concerned with the immorality of birth control or premarital sex per se. Expanding access through nonprescription sales could be considered both a "pro-life" position, in that it had the potential to prevent unintended pregnancies and thus reduce abortion rates, and a "pro-choice" position. Most importantly, making the pill widely available in drug stores would drive up access and drive down costs without burdening religious employers who object to subsidizing contraception.
But it was precisely the compromise nature of this effort that offended progressives, who had already shown no mercy for morality-based opt-outs. Many couldn't see beyond a suspicion that sudden conservative support for OTC pills was just some attempt to undermine the ACA contraception mandate.
A Dark Moment for Democrats
Rather than working with Republicans to craft a compromise measure—say, one that protected insurance coverage for contraception but also paved the way for over-the-counter pills—and helping to secure a rare bipartisan win for women's health care, liberals actively advocated against conservative colleagues' efforts.
Cecile Richards, president of Planned Parenthood, suggested, without evidence, that making pills available over the counter would hike costs for individual women to $600 a year. Republican politicians pushing for OTC pills, she said, would somehow "drag women back to the 1950s."
In 2014, Planned Parenthood's political arm bought ads in multiple states. "In its first TV ad buy of the 2014 cycle," noted HuffPost, "Planned Parenthood's political arm is warning voters in North Carolina and Colorado that Republican Senate candidates' support for over-the-counter birth control is not what it seems."
A representative 2015 piece in Salon by feminist writer Katie McDonough called the OTC pill push "a transparent attempt to chip away at the Affordable Care Act" that would "do very little to expand access, particularly to low-income women in rural areas." Apparently, expanding access wasn't really expanding access unless insurance companies were involved.
This was a dark moment in Democratic politics: Even as they ramped up efforts to portray Republicans as the harbingers of a Handmaid's Tale scenario and to portray themselves as hip to the needs of marginalized groups, Democrats sacrificed an opportunity to help women struggling to obtain birth control prevent unintended pregnancies. Instead, at the expense of undocumented immigrants, low-income women, victims of domestic violence, and others, they opted to help middle-class women save $10 a month—and prop up insurance providers, pharmaceutical companies, and the Democratic fundraising machine in the process.
All the while, they insisted that they were putting contraception in reach for more American women. But evidence suggests they were merely shifting around costs.
Between 2013 and 2017—the years in which employers were required to come into compliance with the ACA's contraception mandate—the percentage of women whose private plans offered no-copay contraception jumped from 45 percent to 75 percent, according to Kaiser Health. Plans covering pills with a copay dropped from 49 to 19 percent. Either way, 94 of those surveyed had employer-subsidized birth control coverage.
Better insurance coverage doesn't equate with better access, though, and America's high rate of unplanned pregnancy suggests insurance alone isn't cutting it. "Having an unplanned pregnancy rate of fifty percent indicates that prescription only OC distribution is inadequate and that there are too many barriers blocking women from acquiring contraception," writes Desire'e Martinelli, then a University of Mississippi School of Law student, in "Sex, Drugs, Trump and Birth Control," published in the William & Mary Journal of Women and the Law.
Making contraception cheaper for those who already have health insurance also excludes a lot of women. The 2017 Kaiser survey found "approximately one in ten (12%) nonelderly adult women" were uninsured at the time of the survey and "an additional 8% of women…had a lapse in coverage in the prior year."
Women are more likely than men to be employed part-time or in informal positions that don't come with health benefits. Those who do have coverage could lose their jobs; should they automatically lose their birth control too? And then there are undocumented and transient women, those in controlling relationships, and other populations for whom participation in the formal economy may be out of reach, public assistance may be unobtainable, or using insurance benefits to prevent pregnancy may be risky or impossible.
No matter how many employer-sponsored plans offer "free" birth control or how many new women are added to the Medicaid rolls, there will still be millions of women left out of any system that conditions affordability and access on insurance and regular doctor's visits. Yet that is the system that opponents of over-the-counter contraception want to keep in place.
Ending Politically Motivated Paternalism
Despite national political attachment to a doomed partisan birth control battle, there is some progress being made on contraception access, thanks to states, private companies, and new technologies.
Five states have recently enacted laws that let pharmacists prescribe birth control pills,obviating the need for a separate trip to the doctor. Others are reforming regulations so that women can obtain up to a year's supply at once and so that they can order their contraceptives online or through the mail. An array of companies have sprung up with innovative tele-prescription services, which let women interact with doctors digitally, skip the ancillary exams, and receive their pill scripts in the mail.
These moves significantly improve on the status quo when it comes to obtaining birth control. But adoption has been spotty, and states don't have the power to switch birth control to totally prescription-free status. That authority lies with the federal Food and Drug Administration (FDA), and the application process is prohibitively expensive for all but the most well-heeled drug companies.
According to Martinelli, "pharmaceutical companies make more from prescription insurance payments than they could if contraception was in a competitive market." So until recently, no drug company saw fit to challenge the way things have always been done. But in late 2016, an international research organization and a French pharmaceutical company—Ibis Reproductive Health and HRA Pharma—announced that they were working "to conduct the research needed and submit an application" to the FDA for a pill designed to minimize the risk of complications. The company has extensive experience in this realm, having launched an E.C. pill all the way back in 1999 and become the leading maker of such drugs in Europe. Perhaps most importantly, HRA Pharma has been through the FDA application process before when it secured over-the-counter approval here in the U.S. for its progestin-only E.C. pill, ellaOne.
It could still be years before the company can conduct all the necessary research and compile all the necessary data to submit an FDA application. "A typical FDA process from the time a drug company begins an application process until a pill is available over the counter is approximately three to five years," says Britt Wahlin, vice president for development and public affairs at Ibis.
With the European private equity group Astorg and Goldman Sachs Merchant Banking Division as majority shareholders, and with plans to accelerate international expansion and grow its women's health care line, HRA Pharma is well-positioned to see this through—as long as political maneuvering doesn't get in the way.
Sadly, that seems like a real possibility. Progressive plans for providing affordable and accessible contraception remain intractably dependent on the ACA mandate being unbending and eternal. But although Obamacare has survived multiple legal and political challenges, it remains a target, with a federal judge declaring the entire act unconstitutional in December 2018. Although there is little chance that ruling will stand, its existence should still serve as a warning to those who would tie medical access to any specific health-insurance coverage scheme, especially one as politically volatile as Obamacare.
Even if the ACA remains in place, certain aspects are less stable. The specific services and drugs that must be "free" to insurance consumers and the types of employers that are allowed to opt out of this coverage for religious or moral reasons are both decided by the executive branch.
Since taking office, President Trump has tried to expand the list of organizations that can be exempted from the contraception mandate. A new set of rules were set to take effect this month, but the details are still being fought over in court. This week, a federal judge has blocked them from taking effect in 18 states and Washington, D.C.
Perhaps now is the time to once again leave old birth-control battle lines behind. January 2019 ushered in a new Congress, and left-right alliances in the Trump era are still being rewritten. Political conditions could finally be right for achieving OTC sales of standard birth control pills.
Under Trump, the left has begun to look for ways to allow for undocumented access to medical care. Social conservatives, meanwhile, have embraced a more libertarian approach to these policy battles, fighting to be free from forced participation in things like birth control coverage or gay weddings but not against others' ability to participate.
Today's Republican leaders largely want to be seen as anti-abortion and pro–religious liberty, but not as religious ideologues, prudes, or people standing in the way of pregnancy prevention—which makes embracing OTC pills a pretty safe bet for them if it's built up as a bipartisan affair. Democratic lawmakers could stand out as both champions of women's rights and bipartisan problem solvers. Instead, the left seems content to remain mired in counterproductive Obamacare politics, at the expense of the women they claim to support.
It's time to leave all that behind. Rather than endless rounds of religious freedom vs. women's health care and partisan posture vs. partisan posture, advocates should be concentrating on making it legal to sell birth control pills over the counter. It's the one thing that could truly ensure widespread access, untethered to a person's ability to afford insurance or ability to make it to the doctor on a regular basis, and unassailable by the whims of pharmacists, physicians, employers, and political administrations.
Women deserve better than politically motivated paternalism, but until birth control can be obtained without permission, that's what we're stuck with.
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