- Plan B is now Plan B One-Step - a new drug application approved by the FDA on July 13, 2009. Plan B One-Step has replaced the old Plan B. Plan B One-Step consists of just one oral pill (levonorgestrel tablet, 1.5 mg). Next Choice One Dose is now also available as the generic alternative of Plan B One-Step.
Plan B (also known as the morning after pill) is a brand of a progestin-only pills approved by the FDA specifically for emergency contraception (EC). Plan B actually consists of two EC pills - each containing the progestin hormone levonorgestrel.
In order to reduce the risk of an unplanned pregnancy, Plan B One-Step should be started up to 3 days (72 hours) after unprotected sex or contraception failure -- this pill should be taken as soon as possible as it is more effective the sooner it is taken. (In general, though, emergency contraception could be initiated up to 5 days (120 hours) after unprotected sex, so Plan B One-Step may still be useful to take for up to 5 days).
Since 2006, women and men 18 or older can buy Plan B over the counter at local pharmacies. Females under the age of 18 must obtain a prescription for Plan B from their doctor. Plan B, which is marketed by Duramed Pharmaceuticals, a subsidiary of Teva Pharmaceuticals, is sold behind the counter in retail pharmacies so that age can be verified prior to dispensing.
Many people have been mislead about who can actually buy Plan B. The confusion stemmed from an April 2009 FDA announcement that Plan B would now be available to women 17 and older without a prescription. This FDA approval lead many to believe that 17-year-olds could now buy Plan B OTC as well. Most people did not even realize that this was NOT the case until the FDA announced, on June 24, 2009, its approval of a prescription-only generic version of the contraceptive Plan B, for women age 17 and younger. This approval is the latest chapter in the long and EXTREMELY confusing history between the FDA and EC, and this news lead many to wonder -- if the FDA already is allowing those over the age of 16 to buy Plan B, then why would a generic prescription brand of Plan B be necessary for 17-year-old girls?
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 OTC access to Plan B.
The question then remains, if this is, indeed the case, why did the FDA announce its approval that 17-year-olds could buy Plan B?
Latest News
On April 22, 2009, the FDA announced that Plan B would now be available to women 17 and older OTC. This decision was the result of a federal court order instructing the FDA to allow 17-year-olds to purchase Plan B and further asked the agency to consider whether the pill should be available OTC to women of all ages. The court ruling found that the FDA’s initial decision to restrict access was based on politics, not science.This 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, 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 OTC, 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 common-sense policy that will help reduce the number of unintended pregnancies and protect the health and safety of all women."
But, at that time, Plan B was still only available to those over the age of 17. The Catch? All the FDA meant by its announcement was that it would now finally allow Plan B’s manufacturer to submit an application for OTC Plan B sales to this age group. Of course when asked about the status of this application, DeLancey (as an FDA employee) couldn't 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.
Current Status of the Plan B Saga:
- July 13, 2012: Next Choice One Dose, one tablet emergency contraceptive received OTC/behind pharmacy counter approval from the FDA for those 17 or older without a prescription.
- December 7, 2011: the FDA decided to grant Teva Pharmaceutical’s request to lift all age restrictions and allow Plan B One-Step to be sold over the counter, without a prescription. However, in a move that has never been done before, Department of Health and Human Services Secretary Kathleen Sebelius overrules the FDA’s approval and orders the agency to deny Teva’s request. Sebelius cites insufficient data to support allowing Plan B One-Step to be available over-the-counter for all girls of reproductive age. She also explained that girls as young as 11 are physically capable of having children and did not feel that Teva proved that younger girls could properly understand how to use this product without adult guidance. This decision upheld the current requirements that Plan B One-Step (as well as Next Choice) must still be sold behind pharmacy counters (without a prescription) once the pharmacist can verify that the purchaser is 17 years old or older.
- August 16, 2010: the FDA gives final approval to the new emergency contraceptive, ella. Ella is only available by prescription, made its way onto pharmacy shelves around December 2010 and works very differently than Plan B One-Step.
- September 2009: the original Plan B product will no longer be on the market (though you may still have a pack at home).
- August 28, 2009: the generic two-tablet emergency contraceptive (Next Choice) received OTC/behind pharmacy counter approval from the FDA for those 17 or older without a prescription. This product initially received FDA approval on June 24, 2009 to be sold only via prescription.
- July 13, 2009: the FDA announced the approval of Plan B One-Step (a single dose pill), the new version of Plan B. At this time, the FDA also officially extended OTC (but still behind pharmacy counters) access to Plan B One-Step for anybody age 17 or older; women younger than age 17 will need a prescription to obtain.
Fuss
All this confusion is just a metaphor for the long and politically-based fight for OTC sales of Plan B. Reproductive health advocates began to have hope again 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 to those age 18 and older who show proof of age while still requiring a prescription for women 17 and younger. However, in a 52-page ruling, Korman ordered the FDA to allow 17-year-olds to buy Plan B without a prescription under the same conditions as Plan B is now 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 a period of 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.
