Who Can Buy Plan B One-Step or Generic Plan B One-Step?

Sorting Through the Emergency Contraception Maze

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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 oral pill (levonorgestrel tablet, 1.5 mg).

In July 2012, the FDA approved Next Choice One Dose, 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 (and those under 18 needed a prescription from their doctor). Plan B (as well as its replacement, Plan B One-Step) is manufactured by Teva Pharmaceuticals.

Now, anybody (of any age) can buy Plan B One-Step or one of its three generic versions, Take Action, My Way or Next Choice One Dose, over-the-counter, without a prescription. The approval process leading to the availability of Plan B One-Step, over-the-counter with no age restriction has been steeped in controversy and confusion -- leaving many people still confused about this emergency contraceptive's current status as well as the approval process leading us to where we are today.

Where the Confusion Began:

Many people have been misled about who can actually buy Plan B One-Step. The confusion originally stemmed from an FDA announcement in April 2009 saying that the FDA will allow Plan B's manufacturer to make Plan B available to women 17 and older without a prescription.

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

The confusion arose based on the following excerpt from the June 2009 press 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."

This FDA press release lead many to wonder -- if the FDA has already approved individuals over the age of 16 to buy Plan B over-the-counter, then why was the FDA announcing that until now, OTC Plan B use was restricted to those at least 18 years of age?

Siobhan DeLancey, who wrote the FDA press release announcing the approval of generic Plan B, answered this question by simply stating, "no matter what the FDA said last April, a 17-year-old does not have over-the-counter access to Plan B".

The question then remained, if this was, indeed the case, why did the FDA announce its approval that 17-year-olds could buy Plan B?

The Explanation:

It seems that much of the confusion stemmed from misinterpreting the April 22, 2009, FDA press announcement supposedly declaring that women 17 years of age and older could now buy Plan B over-the-counter.

This FDA decision was the result of a federal court order instructing the FDA to allow 17-year-olds to buy Plan B. Judge Korman further asked the agency to consider whether the pill should be available over-the-counter to women of all ages. The court ruling found that the FDA’s initial decision to restrict access was based on politics and not science.

In the agency's announcement, the FDA statement explains,

"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. And that's the way it should be. This decision is a common-sense policy that will help reduce the number of unintended pregnancies and protect the health and safety of all women."

Yet, at that 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 (the FDA spokesperson) 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 a metaphor for the long and politically-charged fight over OTC sales of Plan B. Reproductive health advocates regain hope for over-the-counter status after the US District Court for the Eastern District of New York ruled, in a March 23, 2009, hearing, 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. 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 said that the FDA deviated from its own standard procedures for reviewing OTC products and that the agency only made a Plan B decision (in 2006) because of threats to hold up Senate confirmation of Dr. Andrew von Eschenbach to become FDA commissioner. 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. Thus, the judge instructed the agency to review whether to make emergency contraception available without any age restriction. The FDA replied that it is reviewing the judge’s decision. Korman further ruled that his order must be complied with within 30 days. This lead to the "infamous" April 2009 FDA press announcement that sparked all the confusion over who could really buy Plan B.

Where We Stand Today:

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 about whether or not Plan B One-Step (or the morning-after pill) terminates a pregnancy.

Emergency contraception continues to be a highly emotional and controversial 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 a medical abortion. The controversy fueling this debate centers on the ways that emergency contraception works. This debate is so heated that it even managed to cloud the FDA's decisions about Plan B, leaving the agency to be accused of allowing politics to dictate their decisions rather than science.

Unfortunately, the misguided belief that emergency contraception causes abortion has created a barrier to the access and use of Plan B One-Step as many people continue to confuse the morning-after pill with the abortion pill (RU486). Whereas the abortion pill results in termination of a pregnancy and is only used after pregnancy is established (and no more than 49 days since a woman’s last menstrual period), Plan B One-Step is used to prevent pregnancy when taken within 3 to 5 days after unprotected sex. It will not harm an existing pregnancy.

In fact, 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 an abortion as the disruption of an implanted fertilized egg. This means that it is impossible for Plan B One-Step to terminate a pregnancy since, medically, a pregnancy doesn't exist. Federal policy, in accordance with medical experts, defines medication, drugs and devices that act before implantation as preventions to pregnancy and not agents that terminate pregnancy.

Plan B One-Step is a safe and effective method for women to PREVENT a possible pregnancy after engaging in unprotected sexual intercourse or experiencing birth control failure and has proven to be a significantly influential option that has helped drastically reduce the number or unwanted pregnancies as well as the number of abortions that would have taken place if these pregnancies were not prevented through the use of emergency contraception.

So, Who Can Buy Plan B One-Step?

As of June 20, 2013, the FDA has accepted Teva's supplemental application and approved Plan B One-Step nonprescription/over-the-counter status. This means that women of all ages can buy Plan B One-Step, which should now be in the family planning aisle/section of local drugstores. 

On February 25, 2014, the FDA announced that Plan B One-Step generic alternatives (My Way and Next Choice One Dose) will now be available without a prescription or any age restrictions -- even though the agency is requiring that these products include on their labels that use is intended for women ages 17 and older. Take Action is also available OTC for any age, but because it is manufactured by Teva, it does no

So... if you need to buy emergency contraception, accessibility is as follows:

  • Plan B One-Step -- can be bought OTC (without a prescription) to those of any age.
  • My Way, Take Action and Next Choice One Dose (Plan B One-Step generic products) -- can be bought OTC,  (without a prescription) to those of any age.
  • Plan B generic Next Choice (two-pill emergency contraception) -- available behind the pharmacy counter, without a prescription, for those aged 17 and older. A prescription is needed for those under 17.

Sources:

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

FDA Newsroom. [04-22-2009] "Updated FDA Action on Plan B (levonorgestrel) Tablets." Accessed 10/6/13.

FDA Newsroom. [06-24-2009] "FDA Approves Generic Prescription-Only Version of Plan B Emergency Contraceptive for Women Ages 17 and Under." Accessed 10/6/13.

Tummino v. Torti, 603 F. Supp. 2d 519 (E.D.N.Y, Mar. 23, 2009). Accessed 10/6/13.

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