FDA set to approve over the counter birth control pill


An influential advisory panel recommended that the Food and Drug Administration (FDA) approve an oral contraceptive pill for over-the-counter use without an age restriction.

While hormonal birth control is available without a prescription in many other countries, this medication, Opill, would be the first such option in the United States. The vote, conducted after a day-and-a-half discussion this week, is a significant step toward making birth control more widely available now that abortion is not federally protected.

The FDA is not obligated to accept the panel’s recommendation but is likely to do so, with a decision expected this summer. The vote means that hormonal birth control could be available without a prescription later this year.

In their review of the manufacturer’s data, FDA scientists surfaced concerns about whether people would know how to properly use the medication without the advice of a physician, highlighting in particular whether people would understand how often to take the medication, the proper way to consume it, the correct dosing, and what medical conditions might render them ineligible for the drug.

Opill, which is made of progestin, is not recommended for people who have had breast cancer. Some FDA scientists also worried that the drug may be less effective for people with higher body weights, who were not considered to the same extent when the drug was first approved in 1973.

But in their discussion this week, the group of scientists advising the FDA — including doctors and biostatisticians — argued that the value of making a safe and effective oral contraceptive more readily available outweighed those concerns. Making the pill an option without a prescription could make it easier for people who otherwise don’t have access to hormonal birth control: minors who are unable to to involve their parents, people who don’t have a regular health care provider, or those whose nearby clinics and health centers don’t provide oral contraceptives.

The over-the-counter birth control pill — which should be taken at the same time every day — is also more effective than other non-prescription methods, such as condoms or diaphragms.

“It’s really an access issue,” said Dr. Katalin Roth, a professor of medicine at George Washington University. “Making it over the counter is the right thing for women.”

There is another factor in all this, one that went unspoken in the official proceedings.

However, there’s another incredibly salient factor that was largely absent from the presentations: the current U.S. abortion landscape.

Per the Guttmacher Institute, 26 states have abortion schemes categorized as “restrictive,” “very restrictive” or “most restrictive.” In many of those states, abortions are virtually inaccessible.

Such a climate makes the accessibility of contraception a critical concern, particularly for girls and women who live in states with the most restrictive regimes. As it is, contraception has been linked to expanded educational opportunities and higher income for women and better outcomes for children; a 2012 National Bureau of Economic Research paper found that one-third of the wage gains women have made since the 1960s stem from the availability of birth control.

Though separate processes, targeting contraception has long been part of the anti-abortion movement, even if its activists sometimes muddied their stance so as not to alienate supporters.

“When emergency contraception first came about, some pharmacists refused to fill prescriptions and said that emergency contraception is an abortifacient, which it isn’t,” Carole Joffe, a sociology professor at the University of California, Davis’ center for global reproductive health, told TPM. “Then it escalates — some were at one point refusing to fill prescriptions for regular birth control.”

Immediately after the anti-abortion movement had its historic victory in the Supreme Court overturning Roe v. Wade, right-wing lawmakers started eyeing intrauterine devices and Plan B, also known as the morning-after pill, to restrict next.

“Going after contraception is such an overreach — but that’s what social movements do,” Joffe added. “When they win one battle, they think they can win more.”

There is of course opposition to this proposal.

Major medical groups, such as the American Medical Association and the American College of Obstetricians and Gynecologists, are backing the request.

But groups like the Catholic Medical Association are opposed, and not just on religious grounds.

In addition to questioning the safety of making a birth control available without a prescription, that group argues that easier access would help sex traffickers and that skipping the requirement to see a doctor would harm women’s health in other ways.

“It eliminates the need to see a physician for young ladies to see a physician for the prescription,” says Dr. Timothy Millea, who head’s the association’s health care policy committee. “That will eliminate the screenings for ovarian cancer, for cervical cancer, for sexually transmitted infections.”

An FDA assessment also raised questions about taking a health professional out the equation. FDA scientists questioned whether women would take the pill every day at the same time, as they’re supposed to, and whether women who shouldn’t take the pill because of certain health problems would know that.

But proponents dismiss those concerns, arguing there’s plenty of evidence that women can easily handle it. Pills are available without a prescription in more than 100 other countries.

“We think the evidence is quite clear,” says Dr. Jack Resneck Jr., the AMA’s president. “First of all, oral contraceptives have been used safely by millions of women in the United States and around the world since the 1960s.”

Moreover, while regular exams are important, “they’re not necessary prior to initiating or refiling an oral contraceptive,” Resneck says.

I don’t have any commentary here, just adding this to the Things To Watch in the coming weeks, as the FDA preps its final decision. We’re past the point where the Lege can do anything ridiculous, but that doesn’t mean there won’t be other opportunities. The forced birth zealots don’t like contraception either, and they’re not going to go away.

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3 Responses to FDA set to approve over the counter birth control pill

  1. Jeff N. says:

    This is an excellent option for young women, and I would like to see additional and better options for young women in Texas, post-Dobbs.

    As parents of young women in their child-bearing years, my wife and I are dealing with daughters who have left Texas or who want to leave Texas. We have several longtime friends who are in the same situation with their daughters. Texas is more like Gilead now than it has been since 1973.

    If we continue policies that are driving out young women who are smart, talented, and educated, what will become of our state? Women make our society more sane. I can’t help but think that the decline of Texas will accelerate.

    I believe that Audrey Abbott, the daughter of Greg and Cecilia, is about 27 now and is living in California. What does that say about our state?

  2. Mainstream says:

    Jeff N–My personal opinion is that the decision of the child of a political officeholder to remain in the state where she attended college says nothing about our state, and ought to be off-limits in political debate. Unless she gets a contract with a Texas state agency, or becomes employed by the state, her decisions and choices should be of no interest to the general public.

  3. C.L. says:

    @Mainstream. Agreed. Where Audrey lives is meaningless to anyone but her and her Parents…and her parents might not even care.

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