Judge Edward Korman of the U.S. District Court’s Eastern District of NY has reversed a Department of Health and Human Services (HHS) decision that restricted over-the-counter (OTC) access to Teva’s Plan B and Plan B One-Step (levonorgestrel 1.5mg) tablets. Judge Korman ordered the FDA to make levonorgestrel-based emergency contraceptives available without a prescription and without point-of-sale or age restrictions within the next 30 days. This also affects Watson’s Next Choice One Dose, the generic of Plan B One-Step.
Plan B was approved in 1999 to prevent pregnancy after known or suspected contraceptive failure or unprotected intercourse. In 2006, the FDA granted OTC access initially for women >18 years of age while still requiring a prescription for younger females, then later, expanded the age limit to include 17 year olds. Plan B One-Step (a single-pill version) was approved in 2009 with the same age restrictions.
While labeled OTC, these emergency contraceptive products can only be obtained “behind the counter” in a pharmacy or clinic because of point-of-sale restrictions. In his ruling, Judge Korman stated “the obstructions in the path of those adolescents in obtaining levonorgestrel-based emergency contraceptives under the current behind-the counter regime have the practical effect of making the contraceptives unavailable without a doctor’s prescription.” The new ruling removes these point-of-sale restrictions allowing easier access to the drug.
The FDA will now have to determine whether new labeling will be necessary for these emergency contraceptive products and whether to limit the over-the-counter approval to just the one-pill product or to include the two-pill product as well.
For more information visit www.nyed.uscourts.gov/sites/default/files/opinions/Tummino%20SJ%20memo.pdf.