- 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).
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?
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 Plan B is 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.
The Latest Development in the Plan B Saga:
As of Septemner 2009, the original Plan B product should no longer be on the market (though you may still have a pack at home). Plan B One-Step, marketed by Teva Women’s Health, is the only emergency contraceptive currently available. It can be bought over the counter (but behind the pharmacy counter) for women and men age 17 and older. A prescription for Plan B One-Step is needed for girls under the age of 17.Also: On June 24, 2009, a generic two-tablet emergency contraceptive (by Watson Laboratories) received OTC approval from the FDA - those 17 or older will be also be able to purchase this without a prescription, but this product is not yet available.
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.
