Contraception

Why Americans Can't Have Over-the-Counter Birth Control Pills

Those with standing to challenge the pill's prescription status also gain from keeping it that way.

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ParentingPatch/Wikimedia

In many parts of the world, a person can walk into a drugstore and—without physician oversight or interference—buy a pack of birth control pills over-the-counter. Perhaps several packs.

Not so in America, where the Food and Drug Administration (FDA) has been considering making oral contraceptives available over-the-counter (OTC) for more than twenty years.

"Plan B," an emergency contraceptive, became available OTC last year. That one-step pill is simply a more potent dose of the same hormones that make up regular birth control pills. There's no good medical justification for the differentiation. Yet in America, regular birth control pills remain stubbornly behind the pharmacy counter and behind the times.

A study published in the journal Contraception recently looked at birth control access in 147 countries. It found oral contraceptives were informally available or legally available without a prescription or screening in 62 percent, while legally available without a prescription but with a screening in 8 percent. They required a prescription in only about one-third of the countries, including Canada and the United States.

In December 2012, the American College of Obstetricians and Gynecologists (ACOG) officially recommended that birth control pills be converted to OTC status in America. In its committee opinion, ACOG studiously decimated the most common objections to making oral and other hormonal contraceptives available OTC. To those concerned OTC birth control pills would prevent women from choosing more effective or longer-lasting options, such as the intrauterine device (IUD), ACOG retorted that "efforts to improve use of long-acting methods of contraception should not preclude efforts to increase access to other methods."

Side effects and safety concerns? The pill is remarkably safe. It's changed little in the past fifty-some years (except to get somewhat safer to due lower estrogen content), and been tested extensively. Plenty of OTC drugs carry some risk: gastrointestinal bleeding for non-steroidal anti-inflammatory drugs like aspirin, liver damage for acetaminophen (Tylenol), and overdose for both. You can't overdose on birth control pills, and you're very unlikely to experience other serious adverse effects.

Scaremongering over the pill tends to focus on it ratcheting up blood clot risk, but this increased risk is actually very small (even for women on the relatively riskier later-generation pills such as Yaz). About 10 per 10,000 women on oral contraceptives will get a blood clot—a risk about half as high as that associated with pregnancy.

There are some conditions which make taking the pill ill-advised but, as ACOG notes, women are capable of self-screening for liabilities. In a 2006 study comparing women's self-assessment of contraindications with medical assessment, 392 of 399 participants and healthcare providers came to the same conclusions on pill eligibility criteria.

Similarly, women could read up on different types of oral contraceptives to decide which one is best for them. It's not as if prescribing these pills is a particularly precise science anyway. In the 12 years I was on the pill, I was prescribed at least ten different brands. All of them prevented pregnancy. None of them came without various problems.

A doctor's prescription is far from a guarantee for the right match, and sometimes more likely to lead to the wrong one, as doctors often push newer and pricier, but not necessarily better, brand-name pills. In any case, a woman who finds a particular pill unpleasant is either stuck with it for 12 months or faces more doctors visits and bills.

With OTC birth control pills, women would still be free to seek medical advice about their options but removed from the burden and cost of having to. "A rational person isn't going to select some birth control pills willy nilly," says Dr. Jeffrey Singer, an Arizona-based surgeon and adjunct scholar at the Cato Institute.

The point is presenting women with wide options when it comes to learning about, selecting, and accessing contraceptive choices. A woman with good health insurance and easy access to care could very well see a doctor for pill recommendations. But an undocumented immigrant, a sexually active 19-year-old whose parents disapprove, a woman in an abusive marriage, a woman who forgot to pack her pills while on vacation … they wouldn't have to. They could walk into a drugstore, consult with a pharmacist, or not, and walk out with a tool to prevent pregnancy.

There's good evidence that OTC contraception could reduce unintended pregnancies. In one 2004 survey, 68 percent of women aged 18 to 44-years-old trying to prevent pregnancy said they would utilize pharmacies for OTC contraceptives such as the pill, the contraceptive patch, the vaginal ring, and emergency contraception. Nearly half of uninsured women and 40 percent of low-income women not currently using any of these methods said they would start doing so if they were available OTC. Studies have also shown that access to multiple pill packs at once results in higher rates of continual use.

OTC birth control pills clearly don't just benefit women—men and society at large gain from fewer unintended pregnancies. Removing health insurance from the contraception equation could lower pill prices. Decreasing unnecessary doctors visits for women could lower health insurance costs and healthcare expenditures overall. It just doesn't make sense from a public health or personal liberty perspective to keep birth control prescription only—though it does make pharmaceutical companies and doctors more money.

"Doctors regularly hold women's birth control prescriptions hostage, forcing them to come in for exams," wrote Stephanie Mencimer in a Mother Jones piece about her own doctor doing so. Dr. Singer described as it doctors extorting pay for a "permission slip" to get the same medication over and over again. Feminist blogger Amanda Marcotte says doctors use "the pill as bait" to make sure women come in once a year.

Both doctors and public health officials publicly worry that women won't receive annual cervical cancer and sexually transmitted infection (STI) screenings without such coercion. How much of this concern is motivated by profit, how much by paternalism, is hard to say.

A 2010 study found 33 percent of doctors always require a pelvic exam and pap smear before prescribing hormonal contraception, and 44 percent regularly do. But there's no medical reason for linking these things. It's like refusing to give someone antibiotics unless they submit to a cholesterol screening.

Perhaps worse, as there's growing evidence that too-frequent Pap smears (which test for cervical cancer) can do more harm than good. The U.S. Preventive Services Task Force now recommends most women only get screened once every three years, not annually. At best, the current overscreening is merely inconvenient and needlessly expensive; at worst, it leads to psychologically-distressing false positives and totally unnecessary but invasive medical procedures.

It's not just some doctors and medical groups who want to keep things status quo. Pharmaceutical companies also gain from it. OTC sales "would drive down the prices substantially," says Singer. Drugmakers can get higher prices from insurance companies than they could in a competitive contraceptive market.

In a 2012 Wall Street Journal op-ed, Louisiana Gov. Bobby Jindal, a self-described "conservative, pro-life" Republican, called OTC birth control a way to "put purchasing power back in the hands of consumers—not employers, not pharmaceutical companies, and not bureaucrats."

Yet the pharmaceutical industry is the only entity with standing to challenge the prescription status of current birth control pills. In order to initiate the switch from prescription to nonprescription, a drug maker must approach the FDA.

Birth Control Review/Wikimedia

This is pursuant to Section 503(b)(3) of the 1938 Federal Food, Drug, and Cosmetic Act and the 1951 Durham-Humphrey Amendments amendments to it. Testifying about the amendments, Rep. Carl Durham (D-North Carolina) noted that prescription status should be able to be changed when new information came along revealing it no longer necessary for public health protection. That seems to be exactly the situation we've found ourselves in with birth control pills.

"FDA is willing to meet with any sponsor, including those of oral contraceptives, who may want to propose switching their product to OTC status," says FDA spokeswoman Andrea Fischer, which is the same thing the agency has been saying for decades. Unsurprisingly, none of the sponsors who profit from keeping contraceptives Rx-only want to challenge that status.

The New York Times noted that some brand-name birth control pills sell for nearly $100 a month, with insurance companies paying most of it, while generic pills can cost under $10. Drugmakers (and doctors) are benefiting from arbitrarily driving up healthcare costs under a system that doesn't make sense.

That system creates situations like this current Hobby Lobby debacle, where we have the Supreme Court negotiating the thorny space between public interest and religious liberty and progressives arguing in favor of a solution that gives women less reproductive autonomy. "Contraception is a personal matter—the government shouldn't be in the business of banning it or requiring a woman's employer to keep tabs on her use of it," as Jindal wrote in his 2012 op-ed.

OTC birth control could render moot the insertion of employers and Uncle Sam into a woman's birth control decisions. It would reduce the burden on women whose employers won't cover contraception, increase access among the most vulnerable populations, drive down healthcare costs, prevent unintended pregnancies, increase individual liberty (for both contraception users and religious objectors), and bring FDA policy just a small, small step toward being more rational. Yet because of the way America's drug approval process is set up and the incentives pushed by our current healthcare system, it also seems highly unlikely America will see it anytime soon.

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  1. Think of the children.

    Or not.

  2. Behind the times? Pseudoephedrine got put behind the counter 9 years ago. There isn’t a unified direction to this – some drugs get more regulated, some less.

    1. There isn’t a unified direction to this – some drugs get more regulated, some less.

      The current situation is pretty whacked up directionally.

      Estrogen (and derivatives) was seen as ‘liberating’ women and is favorable. Despite similar effects and modes of action and a concurrent ‘side effect’ of muscle growth, Testosterone for men is/was maligned.

  3. Everything should be OTC

    1. No, everything should be sold in bins like a candy store… if individual proprietors wish to sell goods in that fashion, anyway, they should not be prevented from doing so.

  4. For a long time, it was the drug companies who labeled their drugs for prescription. That made sense – they had an incentive to see their product used correctly. It really wasn’t until the Durham-Humphrey Amendment in 1951 that the FDA started regulating prescription practice.

    As Emily mentioned, the process for moving a drug from prescription to OTC is arduous, and is most commonly done by drug companies when their drugs go off patent. That’s not to say it’s common, just that, if they’re going to do it, that’s when they do.

    1. And by Emily, I meant Elizabeth. TIWTANLW

  5. “Oral Contraceptives” – is that what the kids are calling it these days?

    *gives approving wink*

  6. Only allowable GOP birth control method = castration.

    Learned that yesterday.

    1. Yikes, and I thought my day was bad! I’m sorry that happened to you, but I don’t think it was the “GOP” who did it. You should have checked Angie’s List to find a legit operation.

    2. By that logic, Democrats want to ban condoms and Plan B, since both of those are OTC and the PPACA banned using HSA and FSA money to pay for OTC medication.

    3. It is almost as if a republican candidate has made a very strong start with a great campaign ad and the democrat party panicked and has been cooking up talking points and passing them out to the usual shills.

    4. I know reading is hard but: In a 2012 Wall Street Journal op-ed, Louisiana Gov. Bobby Jindal, a self-described “conservative, pro-life” REPUBLICAN, called OTC birth control a way to “put purchasing power back in the hands of consumers?not employers, not pharmaceutical companies, and not bureaucrats.” I’m no fan of the GOP but there is such a thing as honesty.

  7. But if birth control pills became OTC, how would we be able to strongarm Korporashunz into buying it for us?

    /Jezebel

    1. Actually, only a sizeable fraction, but not a majority, of Jezebel commenters say that. Too many of them, but I have found that most think that it should be OTC.

    2. Yeah, because the political group blocking FDA approval of things like RU-486 and Plan B was left wing feminists.

      This is a case where the Baptist side of the “Baptists and Bootleggers” team is primarily responsible. Socons who’d prefer to ban birth control outright have settled for making it unnecessarily hard to get by requiring it to be prescription only.

      1. bull-fucking-shit. The people who started the FDA and continue to enable are *the main problem*. lobbyists are going to do what they’re going to do, but it’s ultimately the wielder of power’s responsibility to wield that power correctly.

        1. That’s like saying gun manufacturers are ultimately responsible for shootings.

          Team Red is perfectly happy to use the big government hammer when it suits their agenda.

          1. SOCONZ!!!!!

            Because Team Blue totally deregulated birth control when they owned all three branches of government from 2009 to 2011.

            In all fairness though, it’s because they were busy in those 2 years passing a health care law mandating prescription coverage for birth control on everyone who purchases health insurance.

            MUH FREEDOM!

          2. “Team Red is perfectly happy to use the big government hammer when it suits their agenda.”
            Damn right, not that the people who comment on Hit & Run notice. To them, only Team Blue does anything wrong.

      2. Socons who’d prefer to ban birth control outright

        That’s some Grade A bullshit right there.

      3. That’s not accurate either, again judging by both polls and my person experience with Jezebel. There’s a disturbing number of self-described “left wing feminists” who do think that it should be up to a doctor, worry about side effects and women not being able to understand them, or who even seriously say that they prefer it not be OTC so that it can be free under insurance instead of having to pay for it.

        Not a majority, but significant.

        Socons who’d prefer to ban birth control outright have settled for making it unnecessarily hard to get by requiring it to be prescription only.

        This is insanely inaccurate. Very few people oppose birth control even “morally,” much less wanting it illegal. The significant coalition of people (not sure if it’s a majority, depends on poll) who want it prescription only is mostly people who worry about side effects and don’t trust people with “dangerous drugs” without a doctor.

        Remember that the PPACA banned using HSAs and FSAs for OTC medicine.

    3. Use your food stamps.

  8. birth control pills remain stubbornly behind the pharmacy counter

    Someone, somewhere must be getting high off birth-control pills.

    1. No, it’s just the nagging worry that someone, somewhere, might have some pleasure.

      1. You can have the pleasure with or without the pills. That’s actually how a lot of us found our way to this mortal coil.

        There’s also other birth control methods, so you can still have the pleasure without consequences (or with greatly diminished chances of it, anyway).

        Not good reasons to keep the pill prescription-only, but I think it’s a somewhat disingenuous way of framing it.

        1. I would agree that this is a lame argument, but the idea that it’s okay because we have condoms brings up the matter of whether women have as much control over their bodies as men. The physical consequences of pregnancy are much greater for the woman than the man. And I know there are some assholes out there going, “but you have to pay child support” etc etc. Well, that would suck and I would sympathize with that, but not as a comparison to the physical ordeal of being pregnant. Some women are terrified of it because it physically hurts not only to give birth but to be pregnant.

          Pills give the woman greater control (control is a really important thing) over her own body more than condoms do. The male doesn’t risk pregnancy and no matter what happens, is in control of his own body. If a women wants to have sex, she should have the option of protecting herself with or without a man doing the same. Also, men can rip off the condom during sex if they want to. Which, if the woman didn’t consent to unprotected sex, is at that point rape.

          And if they do, they were the ones who found pleasure while potentially sentencing the woman to physical torture.

          So, women definitely SHOULD have easier access to something that gives them control over their bodies and allows them to enjoy pleasure if they so wish it.

  9. OK wow, why didnt I ever think of that?

    http://www.EliteVPN.tk

  10. But if we give people a taste of freedom what more shall they expect?

  11. A woman with good health insurance and easy access to care could very well see a doctor for pill recommendations. But an undocumented immigrant, a sexually active 19-year-old whose parents disapprove, a woman in an abusive marriage, a woman who forgot to pack her pills while on vacation ? they wouldn’t have to.

    I wasn’t aware that undocumented immigrants, sexually active adults who live with their parents, or women in abusive marriages were barred from seeing doctors. I’m guessing Ms. Brown hasn’t ever been to a public health clinic.

    1. And I’m not saying they should be required to, since I don’t support any regulation of drugs, it’s just that the argument is mindless.

      1. It’s almost as if they don’t HAVE doctors. Or, their parents are control of the insurance. And wow. Abusive marriage = you’re being abused. As in you can’t do what you want because your partner is controlling you with force.

        You are the mindless one here. Think. T H I N K.

  12. Does anyone at Reason have a clue what goes on in medicine? You think prescribing birth control is profitable for doctors? I prescribe them often for acne. I make about $55 on an acne visit. My overhead is $65 per visit thanks to all the bureaucracy. I LOSE money on every acne patient. I’d LOVE to give you a ten-year prescription or refill via email. The medical Board of North Carolina requires seeing patients annually to prescribe. Go read the rules yourself. Make me immune to legal BS for “not following NC Medical Board policy” and I will write you a lifetime Rx. Until then you have no business blaming me for the silliness of the system. Because when that patient strokes – and they do – all the jury will hear is I didn’t follow the protocol.

    1. I agree, its not doctors. The only lobby interested in this are the fanatics. They want to prevent access, that’s it.

  13. The article is wrong: You don’t have to be a drug maker to sponsor a change in a drug’s status from Rx-only to OTC. Anyone can sponsor such a petition. It might be an expensive proposition to gather & present the required evidence, but anyone’s allowed to do it.

    1. That is not what the spokeswoman from the FDA told me.

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  15. Liz, Liz LIZ! Don’t you realize that now that Obamacare has made ALL medicine and ALL medical care is FREE theres NO reason to worry about silly issues like “regulation” and “counters”? I know your not some kindof FASCISTBUSHBIG!!!!11! so I’ll assume this is just a simple oversight on your part.
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  17. By golly we need to have doctors involved in birth control, but how about medical weed?

  18. Thank you for writing this I always wondered why no one talked about this during the whole Sandra Fluke debacle. My wife is from Brazil(a country with plenty of problems) but one thing they have right is buying BC OTC. She could get a months supply for the equivalent of under $3! Meanwhile in the U.S. it’s a $200 doctors visit to get the script, and then it varies but its more like $30 for a month.

    Back when Sandra Fluke was headline news it really bothered me why NONE of the TV commentators both from the left and right even suggested this. Make BC be OTC and it becomes so cheap that no one cares if it must be covered in some plan.

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