Medication portion of PREVEN Emergency Contraceptive Kit. Photo: Smithsonian Institution
In 1993, the New York Times Magazine posited that the morning-after pill might be “the best-kept contraceptive secret in America.” Even many doctors had no idea there was a fallback contraceptive that could be used shortly after unprotected sex or cases of rape.
In many ways, the morning-after pill had been right in front of U.S. doctors for decades. In terms of chemical composition, it was not much different from standard birth control, using the same main ingredients — synthetic hormones — in higher doses. Moreover, many of their colleagues in Europe and Asia had already been prescribing morning-after pills for years.
In 1998, years of research and advocacy led to the first FDA-approved morning-after pill.
Here, however, the secret was still largely intact. A 1994 study by the Kaiser Family Foundation revealed that two-thirds of American women had never heard of the morning-after pill or other forms of emergency contraception (EC). Less than 1 percent had ever used them.
There was an information shortfall in large part because there was no contraceptive that was approved by the U.S. Food and Drug Administration (FDA) specifically for emergency use. Some providers worked around that absence by using the chemically similar estrogen and progestin medications that were approved for regular birth control. By upping the dosage, they created a suitable morning-after pill on their own. But drug makers couldn’t label or market those birth-control pills for emergency, post-coital use, since they weren’t FDA-approved for that purpose. It also spelled problems for federally funded clinics. Federal dollars couldn’t pay for an off-label medication hack, a makeshift morning-after pill that wasn’t officially approved.
On September 2, 1998 — 20 years ago this week — all of that changed when the FDA approved the sale of the PREVEN Emergency Contraceptive Kit. Its two-dose system worked by preventing the fertilization of ova in the hours after sexual contact — or, barring that, by altering the tubal movement of ova before pregnancy is possible. Though it was commonly called a “morning-after pill,” it worked within the first 72 hours after sex.
To mark its anniversary here in the U.S., here are five things to know about the morning-after pill — as well as other emergency contraception.
1. Though it’s only been on the U.S. market for 20 years, the science behind the morning-after pill goes back almost a century.
In the 1920s, veterinarians discovered they could use concentrated estrogen to prevent pregnancy in animals shortly after they mated. In the next decades, that discovery led to attempts at preventing human pregnancies under similar circumstances. Birth-control pills, or low-dose estrogens, could be used proactively to prevent pregnancy, but when it was too late for that, high-dose estrogens were tested as a last-chance contraceptive. The first documented case was in the mid-1960s, when physicians used estrogen medications to prevent pregnancy in a 13-year-old rape victim.
In the 1970s, a Canadian physician named Albert Yuzpe spearheaded clinical trials to develop a combination of hormones, including estrogen and progestin, that could be used as a morning-after pill. He and his colleagues published the first studies on this multi-pill, high-dose hormone method in 1974, establishing a method that was safe and effective for reducing the chance of pregnancy up to 120 hours after unprotected sex.
Though the method was very effective, successfully preventing pregnancy for 98 to 99 percent of users, its side effects, like nausea and vomiting, were much worse than today’s morning-after pills. Over the next 20 years, researchers worked to improve on Dr. Yuzpe’s idea, developing several variations, but the same basic concept, a combination of estrogen and progestin, was behind the first morning-after pill that received FDA approval.
2. Activism helped bring the morning-after pill to the market.
When New York legalized abortion in 1970 (a few years before Roe v. Wade legalized it nationally), Dr. Felicia Stewart took it as her cue to start working at one of the first clinics to offer the service. While she remained committed to the idea of abortion access, her years of caring for abortion patients convinced her she should become an advocate for emergency contraception. What she learned anecdotally, and in a more structured survey of 200 abortion patients, was that many had realized right away they might be pregnant — and those who did would have preferred a morning-after pill to abortion.
Many reproductive justice advocates had spent the 1980s watching abortion rights and birth-control access slowly erode under two conservative presidential administrations. As such, emergency contraception appealed to them as another resource women should have when other options might be out of reach. The idea gained traction in 1993 when the National Women’s Health Network issued a position paper in favor of emergency contraception. A bigger boost would come in 1996 when a New Jersey-based EC information service started airing 30-second spots on MTV. Its advertised hotline, 1-888-NOT-2-LATE, promoted awareness of how conventional oral contraceptives could be used off-label as a morning-after pill.
3. By 1997, the FDA agreed with the need for a morning-after pill, and in 1998, PREVEN hit the market.
While ads on MTV brought awareness of EC to a younger generation of TV viewers, NBC did the same for a broader cross-section of Americans in 1997. An episode of the hospital drama ER that aired that spring included a brief storyline involving a victim of date rape who was advised to take birth control in high doses to prevent pregnancy. It was a sign the morning-after pill had entered the mainstream.
Also in 1997, the FDA validated EC more officially. As CNN reported, “the FDA said six brands of birth control pills were safe and effective as morning-after pills, the first federal acknowledgment of the emergency birth control method that European women have been prescribed for years.” Late that year, drug maker Gynétics applied for FDA approval of the PREVEN Emergency Contraceptive Kit, and the following September, it was given the green light for prescription use. A designated morning-after pill was finally available, though the estrogen-and-progestin combination pioneered by Dr. Yuzpe — now packaged under the name PREVEN — would soon be eclipsed by a new generation of emergency oral contraceptives.
4. Plan B followed PREVEN in 1999 and completely replaced it in 2004.
Though PREVEN paved the way in 1998, the FDA approved another morning-after pill in 1999 that soon overshadowed it in popularity. Plan B, which introduced a new class of progestin-only morning-after pills, was more effective than PREVEN and had fewer side effects. In February 2004, Gynétics sold its rights to PREVEN to Barr Pharmaceuticals, the maker of Plan B, for just $4,200. Months later, Barr withdrew PREVEN from the market.
Though it may have the most name recognition, Plan B is just one of the EC options that have become available since the rise and fall of PREVEN. Others include Next Choice, ella, Take Action, and ParaGard. Besides oral medications (morning-after pills), intrauterine technologies are included in the variety of EC available today. At Planned Parenthood health centers, providers are available to review a patient’s many options for both regular and emergency contraceptives.
5. The FDA made Plan B available over the counter in 2006 — but the fight to keep it accessible continues.
In early 2001, the Center for Reproductive Rights and more than 60 other medical and consumer groups filed a petition with the FDA to make the morning-after pill available without a prescription. The FDA assembled an independent panel of experts in 2003 to consider the risks and benefits of increasing access to the morning-after pill. The panel voted 23 to 4 to make Plan B available over the counter, but it would take another three years before the petition’s demands and the panel’s recommendations would become reality. Finally, on August 23, 2006, the FDA approved Plan B for over-the-counter sales to consumers of at least 18 years of age. In 2013, the FDA dropped its age restriction on Plan B, giving access to the morning-after pill a further boost.
Though a lot of the major barriers have now been cleared, work remains to ensure access to the morning-after pill and other EC. The National Women’s Law Center notes many remaining obstacles, including the need for more awareness about EC, the need to merchandise non-prescription EC on pharmacy sales floors instead of behind pharmacy counters, and the need to challenge retailers and state laws that allow employees to refuse to sell EC on religious grounds.
Another potential battle on the horizon is the attempt by anti-abortion groups to redefine when pregnancy begins so that emergency contraceptives can be reclassified as abortion medications — thus subjecting them to tighter restrictions. While their efforts to redefine pregnancy fly in the face of science, we are now under what many academics and advocates for science have called the most anti-science administration in history.
The milestones we celebrate today will have to serve as motivation for the fights we face tomorrow. We’ve won on many fronts so far. Now it’s time to keep winning.
