FDA Approves Generic and One-Step Plan B, OTC Access for 17-Year-Olds
By Rachel Walden — July 14, 2009
If you’re somewhat confused about who can get what forms of emergency contraception and how, you’re not alone. Recent decisions and approvals related to age, dose, and a generic version make the availability details somewhat baffling, but I hope the following will shed some light on the matter.
Earlier this year, a judge ordered that Plan B be made available over-the-counter (OTC) to women 17 and older, rather than the previously set age limit of 18. At that time, the FDA explained that they would not appeal the decision because it was consistent with the scientific findings on the drug, stating that: “…the FDA notified the manufacturer of Plan B informing the company that it may, upon submission and approval of an appropriate application, market Plan B without a prescription to women 17 years of age and older.”
However, it wasn’t immediately clear whether the manufacturer had asked for such approval or when it might be issued. The FDA website now indicates a label change meaning that “both Plan B One-Step (see below) and Plan B will be available without a prescription to women 17 years of age and older.”
Last month, a generic version of Plan B (levonorgestrel, to be marketed under the name “Next Choice” according to a company press release) was approved by the FDA, “by prescription only for women ages 17 and under.” While you may assume that the “by prescription only” line is meant to remind us that Plan B has only been available OTC for women 18 and older, that’s not the case. As the FDA’s release notes, “No generic levonorgestrel product for emergency contraception can be approved for nonprescription use in women ages 18 and older until Aug. 24, 2009, when the marketing exclusivity held by Duramed for the nonprescription use expires.”
Will the generic version be available to women 18 and older on Aug. 24? We don’t quite know yet. It has been suggested that women older than 17 could get the generic version prescribed as an off-label use, but that would of course require a visit to a clinician.
Finally, a 1.5 mg one-pill version of the drug (Plan B One-Step) also has just been approved by the FDA. The older Plan B requires users to take one 0.75 mg pill within 72 hours after intercourse and a second 0.75 mg pill 12 hours later. The new Plan B One-Step means a woman will only need to take one pill. It will follow the same (but new!) rules as regular Plan B, with OTC access for women 17 and older, and prescription access for younger women.
In summary, and as best I can tell, here’s the availability breakdown right now:
|17 and up||Younger than 17 years|
|Plan B||OTC (new OTC access for 17-year-olds)||Prescription Only|
|Single Dose Plan B (Plan B One-Step)||OTC||Prescription Only|
|Generic Plan B (NextStep)||Not until after 8/24/09 (actual date uncertain); 17-year-olds may get via prescription||Prescription Only|