News Analysis: Is It Time for Off-the-Shelf Birth-Control Pills?

WHEN a federal judge recently ordered the Food and Drug Administration to make the morning-after pill available to women of all ages without a prescription, the ruling was a political embarrassment for the Obama administration and unleashed protests from abortion foes and abstinence advocates. But that controversy may look like a tempest in a teapot compared with a broader and no less heated discussion that is roiling the medical community: should birth-control pills of any type require a doctor's prescription? Or should they be available, like Tylenol, on pharmacy shelves?

Last December the American College of Obstetricians and Gynecologists released an official position paper concluding that the time had come for birth-control pills to be sold over the counter. It was the first time the group had endorsed such sales, concluding that scientific evidence suggested that the practice was safe and calling it "a potential way to improve contraceptive access and use, and possibly decrease the unintended pregnancy rate."

After all, oral contraceptives have been available in the United States for more than half a century, and few medicines have been so thoroughly vetted. Despite some catchy new brand names, the pills I took 25 years ago are essentially the same as those my daughter takes today. If anything, pills have become safer because they contain lower doses of estrogen.

While oral contraceptives bring with them some tiny risks, especially if used improperly, they arguably pose fewer dangers than many other medicines bought freely at the pharmacy, experts say, including nonsteroidal pain pills like Motrin (which can cause stomach bleeding) and decongestants like Sudafed (which may raise blood pressure). With a simple packaging insert about proper use and precautions, women would be fully capable of using them safely, the gynecologists' group maintained.

"Nonsteroidal medicines kill far more people than birth-control pills," said Dr. Eve Espey, a professor of obstetrics and gynecology at the University of New Mexico, who was involved in writing the position paper. "For most women, the absolute risk of taking the pill is far less than the risks incurred in pregnancy."

The goal of the proposal, of course, is to make birth-control pills more readily available. "The biggest barrier to adherence is the logistics of a prescription — you run out on a Saturday night, you lose your pills, you go on vacation, you can't get a doctor's appointment," said Daniel Grossman, a gynecologist who is a vice president at Ibis Reproductive Health, a nonprofit research organization.

In his group's studies, about one-third of the women who were using no birth control or a less effective method said they would use the pill if it were available without a prescription. "This is what women want," Dr. Grossman added.

But pregnancy, prescriptions and religious politics form a combustible mix in the United States, and Lo/Ovral is not likely to be next to the Tylenol anytime soon.

While women's health advocates gleefully called the American College's endorsement "a game changer" in the quest for over-the-counter sales of birth-control pills, members of the Catholic Medical Association lambasted the idea.

Gynecologists themselves seem divided on the issue. A recent poll found that a majority of gynecologists and family doctors in training opposed the practice, worried mainly about safety. The researchers at the University of Missouri who conducted the survey concluded that the fear was irrational, revealing "a knowledge deficit" about "the safety of oral contraceptives."

But Dr. Donna Harrison, executive director of the American Association of Pro-Life Obstetricians and Gynecologists, said her group believed that it was "foolish to make these medicines available over the counter" because of the potential for misuse and also because the practice served to abandon and isolate younger women who needed a doctor's counsel. She cited studies showing that women who had ready access to over-the-counter emergency contraception had higher rates of sexually transmitted diseases.

The political response has been even more topsy-turvy. Gov. Bobby Jindal of Louisiana, a Republican who opposes abortion, endorsed the American College's proposal, saying that contraception was a personal issue.

Meanwhile, the F.D.A. will not comment on the idea because of the "ongoing legal issues" concerning the judicial ruling on the morning-after pill, Plan B, said Stephanie Yao, a spokeswoman. The morning-after pill, also known as emergency contraception, contains the same hormones as some birth-control pills, though delivered in a short blast and higher dose.

That legal dispute has highlighted the Obama administration's hair splitting over the sensitive issue of contraceptive policy. Even though F.D.A. doctors said in 2011 that studies showed that it was safe to sell Plan B, the most common emergency contraceptive, to adolescents over the counter, the administration refused to approve the practice. (It was already available to older women.) That set the stage for the ruling earlier this month by Judge Edward R. Korman of the Eastern District of New York, who called the administration's action "politically motivated and scientifically unjustified" — essentially an attempt to appease religious conservatives.

Politics aside, there are procedural hurdles to clear before packs of birth-control pills can be sold without prescription. First of all, a drug maker would most likely have to apply to the F.D.A. to make the switch. At the very least, that would involve serious investment in studies to show that patients could understand labels and use the pills as directed. And over-the-counter sales could upend drug company profits. After all, some oral prescription contraceptives sell for close to $100 a month, with insurers paying the bulk of the costs, while generic pills cost under $10.

Dr. Espey said gynecologists might resist for financial reasons as well, since young women often visit the gynecologist annually solely for the purpose of getting a contraceptive prescription. (Pap smears, which used to be recommended once a year, are now advised only once every three.) "They worry that if patients can go to the pharmacy and get their pills, they will have fewer visits," she said.

As for safety, the most common birth-control pill — which combines progestin with a low dose of estrogen — poses a very slightly elevated risk of blood clots and a few other conditions. But that is mostly for certain groups of women, including those with high blood pressure or those who are over 35 and smoke, for example (these women are advised not use them). But warnings could be conveyed in package labeling, just as patients with a history of ulcers are advised not to take certain pain medications. And a few alternative birth-control pills that contain only progestin are generally safe for all.

So far the debate has been argued in black and white. But there is, in fact, a middle ground: many countries that allow pharmacies to sell birth-control pills require that a pharmacist screen women for contraindications with a few simple questions.

My daughter spends hundreds of dollars a year for a gynecologist's visit to obtain a prescription for the same pill I got a quarter-century earlier. She goes through elaborate machinations to get them if she runs out while away on a summer job. The Affordable Care Act of 2010 seeks to improve access to the pills by eventually eliminating patient copays when prescriptions are filled. But many doctors think it would be even smarter to just eliminate the prescription.

Elisabeth Rosenthal is a reporter on the environment and health for The New York Times.