Plan B One-Step now on store shelves

Teva granted 3 years of exclusivity


Following a drawn-out legal battle, Teva’s Plan B One-Step (levonorgestrel) is now available in pharmacies OTC with no age or sale restrictions.

The new packaging now has the words “New! Now Available Over the Counter” in pink and periwinkle.

According to the Plan B One-Step website, “you can start by looking for Plan B One-Step in the aisle. Otherwise ask anyone in the store where it’s located. Then just take it off the shelf, and pay for it at the cashier. No prescription or ID required.” The store locator on the website lists pharmacies and stores with pharmacies.

The brand-name product is now the only emergency contraceptive product available OTC to younger adolescents. The availability of two-dose emergency contraceptive products has not changed; they are OTC only for women aged 17 years and older if purchased at a pharmacy with government-issued proof of age.

On July 22, FDA granted Teva marketing exclusivity for 3 years for Plan B One-Step. On June 20, FDA lifted age and sale restrictions for Plan B One-Step after a federal judge approved the government’s proposal to do so and drop its appeal of an April 5 court order. Thus ended a lawsuit brought in 2005 by organizations and individuals concerned with women’s health, as well as minors and their parents, to challenge FDA’s denial of a 2001 citizen petition seeking OTC access to Plan B (which is no longer marketed) for all ages.

Plan B One-Step costs about $50 without any coupons or discounts, Michael Kim, PharmD, President of Grubb’s Care Pharmacy and Grubb’s NW Specialty Pharmacy in Washington, DC. “The price has not gone up significantly in the past year,” he said. The wholesale price on the OTC product is priced about 7% higher than when it was prescription only.

Kim keeps Plan B One-Step “behind the pharmacy counter for security reasons,” he said. “I am in the process of making a locking-glass display near the register, and we will most likely keep it there.”

Who buys Plan B One-Step? The pattern at Kim’s pharmacy has been women in their twenties and thirties. “Generally, the women do not seek counseling from the pharmacists,” Kim said. “The question that I have been asked most often in the past has been how long after intercourse can [the tablet be taken] and still be effective?”