Plan B One-Step Buying Restrictions

Morning-After Pills stylistic photo

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Plan B One-Step received FDA-approval on July 13, 2009, replacing the old two-pill Plan B. This emergency contraceptive consists of just one 1-milligram levonorgestrel tablet.

In July 2012, the FDA approved Next Choice One Dose. By February 2013, the FDA approved My Way, and, in February 2014, the FDA approved Take Action. All three are generic one-pill alternatives to Plan B One-Step. (There is also another generic alternative called AfterPill, but this can only be bought online.)

Since 2006, women and men ages 18 and older have been allowed to buy Plan B over-the-counter at local pharmacies. Those under 18 needed a prescription from their doctor. Those restrictions have since been lifted.

As of June 20, 2013, anyone of any age can buy Plan B One-Step or any of its three generic versions without a prescription.

Confusion and Controversy

The decision to lift the age restriction on Plan B One-Step has been steeped in controversy and confusion, leaving many people to question whether you need to see a doctor before obtaining emergency controversy.

The confusion stemmed from an FDA announcement released in April 2009 stating that the FDA will allow Plan B's manufacturer to make the product available to women 17 and older without a prescription.

This statement led many to believe, understandably, that 17-year-olds could now buy Plan B over the counter. Most people did not realize that this until the FDA announced, on June 24, 2009, that it had approved Next Choice, a prescription-only generic version of the emergency contraceptive Plan B, for women age 17 and younger.

The confusion arose from the following excerpt from the June 2009 release:

"In 2006, Plan B was approved for nonprescription use for women ages 18 and older. Plan B remained available as a prescription-only product for women ages 17 and under. Today's approval allows marketing of a prescription-only generic product for women ages 17 and under."

Siobhan DeLancey, who wrote the FDA press release, stated that "no matter what the FDA said last April, a 17-year-old does not have over-the-counter access to Plan B."

Federal Court Ruling

Much of the confusion about Plan's B access stemmed from what the FDA intended to do and what they were ordered to do by the United States District Court for the Eastern District of New York. By most accounts, the FDA knew they were required to open access but dragged their feet on the implementation of the order.

Ultimately, the decision to expand access to Plan B was mandated not by the FDA but by federal court Judge Edward Korman who ruled that the decision to restrict access was based on politics and not science.

In the agency's announcement, the FDA statement explained:

"In accordance with the court's order, and consistent with the scientific findings since 2005 by the Center for Drug Evaluation and Research, the FDA sent a letter to the manufacturer of Plan B that the company may, upon submission and approval of an appropriate application, market Plan B without a prescription to women 17 years of age and older."

Believing that this news meant that 17-year-olds can now buy Plan B over-the-counter, reproductive health advocates cheered. Cecile Richards, president of Planned Parenthood Federation of America, even said that the FDA's approval is "a strong statement to American women that their health comes before politics."

Yet, at the time, Plan B was still only available to those over the age of 17. The catch? All that the FDA meant by its announcement was that the agency would now finally allow Plan B’s manufacturer to submit an application for over-the-counter sales status of Plan B to this age group.

When asked about the status of this application, DeLancey would not say whether or not this application has been submitted, but would only comment that no application for OTC sales to 17-year-olds has been approved.

A Politically-Charged History

All of this confusion over who can buy Plan B One-Step is just another example of the long and politically-charged fight over OTC sales of Plan B.

Reproductive health advocates regained hope after the U.S. District Court for the Eastern District of New York ruled on March 23, 2009 that the FDA must reconsider its decision under the Bush Administration to limit access to emergency contraception. US District Judge Edward Korman further stated that the FDA allowed politics to interfere with its usual decision-making.

In 2006, FDA officials allowed for easier, behind-the-counter sales of Plan B allowing those age 18 and older to buy Plan B after showing proof of age while still requiring a prescription for women 17 years of age and younger.

In fact, the 2006 decision had been drawn out over three years as the Bush administration opposed FDA approval of Plan B, citing "safety concerns," even though FDA advisory panels recommended that there should be no age limitations on who could buy Plan B.

However, in a 52-page ruling, Judge Korman ordered the FDA to allow 17-year-olds to buy Plan B without a prescription under the same conditions that Plan B was available to women over the age of 18, stating, "The FDA repeatedly and unreasonably delayed issuing a decision on Plan B for suspect reasons.”

The court further ruled that the FDA restricted access to Plan B due to threats that the Senate would hold up the confirmation of Dr. Andrew von Eschenbach as the new FDA commissioner.

In handing down his ruling, Korman stated that the order must be complied with within 30 days, leading to the infamous April 2009 press announcement and the ensuing confusion.

Ongoing Debate

Though the concept of emergency contraception is not a new idea to society, it is still igniting many debates just as it did when it was first introduced to the United States. The controversy stems from people's beliefs regarding whether Plan B One-Step terminates a life or not.

Emergency contraception continues to be a highly emotional issue, both for advocates who believe Plan B One-Step will lower the number of unintended pregnancies and abortions and for opponents who believe that using Plan B One-Step amounts to "medical abortion."

The misguided belief that emergency contraception causes abortion stems from ongoing confusion about the morning-after pill and the abortion pill (RU486), which some people believe are the same thing.

Whereas the abortion pill results in termination of a pregnancy and is only used after pregnancy is established, Plan B One-Step is used to prevent pregnancy when taken within three to five days after unprotected sex. It cannot harm or affect an existing pregnancy.

Most medical experts consider a pregnancy to be established after the implantation of a fertilized egg has occurred. Advocates of emergency contraception remain firm about informing people that Plan B One-Step is not an agent of abortion. Medical authorities define abortion as the disruption of an implanted fertilized egg.

Current Status

Plan B One-Step is a safe and effective way to prevent pregnancy after engaging in unprotected sex or experiencing birth control failure. It has proven to drastically reduce the rate of unwanted pregnancies as well as the number of abortions that would have taken place if these pregnancies had not prevented.

As of June 20, 2013, the FDA has approved Plan B One-Step's over-the-counter status. This means that women of all ages can buy Plan B One-Step without a prescription.

On February 25, 2014, the FDA announced that Plan B generic alternatives would also be available without a prescription or any age restrictions (even though the agency still requires manufacturers to state that they are "intended for women ages 17 and older.")

If you need to buy emergency contraception, Plan B One-Step, My Way, Take Action, and Next Choice One Dose can all be purchased without a prescription for women of any age.

Next Choice (the two-pill emergency contraceptive option) is available behind the counter without a prescription for women 17 and older. Women under 17 still need a prescription.

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Article Sources

  1. Office of Women's Health. Approval of emergency contraception. Washington, D.C.; updated April 1, 2019.


Additional Reading

  • Tummino v. Torti, 603 F. Supp. 2d 519 (E.D.N.Y, Mar. 23, 2009).

  • FDA Newsroom. [04-22-2009] "Updated FDA Action on Plan B (levonorgestrel) Tablets."

  • FDA Newsroom. [06-24-2009] "FDA Approves Generic Prescription-Only Version of Plan B Emergency Contraceptive for Women Ages 17 and Under."

  • FDA Drug Databases. [10-03-2013] "Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations."