Appeal filed to delay unrestricted EC sales

Unrestricted access to emergency contraceptive pills (ECPs) remains blocked. The U.S. Department of Justice (DOJ) filed an appeal May 13, 2013, to delay the sale of ECPs to women of any age without a prescription.

The legal paperwork asked the Second U.S. Circuit Court of Appeals in Manhattan to postpone U.S. District Court Judge Edward Korman’s April 5 ruling that eliminated age limits on the drug while the government appeals that overall decision. On May 6, 2013, Korman denied the DOJ’s request to postpone his ruling while the government appealed, but he gave them until May 13 to appeal again. [Contraceptive Technology Update issued separate e-bulletins on the judge’s actions. To receive breaking news as it occurs, provide your email address to AHC Media customer service at customerservice@ahcmedia.com or (800) 688-2421.]

The April 5 ruling by Korman, if had been enacted, would have the Food and Drug Administration (FDA) make all levonorgestrel-based emergency contraception available without a prescription and without point-of-sale or age restrictions. The judge’s April 5 ruling came in response to the New York City-based Center for Reproductive Rights’ renewed lawsuit against the FDA to expand over-the counter EC access to women of all ages.

“Women who urgently need emergency contraception have been delayed in getting it or denied access entirely for more than a decade because of the political maneuverings of the last two presidential administrations,” said Nancy Northup, president and CEO of the center. “The federal court has made clear that these stalling tactics were based purely on politics, not science.”

According to Center spokesperson Kate Bernyk, it expects the Second Circuit to be fully briefed on the stay motion by the end of May and rule some time after that. “Because Korman granted the government a temporary stay of his order so they could have time to ask the Second Circuit if they could delay compliance pending their overall appeal of his decision, the FDA does not have to yet take action to move all levonorgestrel EC over the counter,” states Bernyk.

Plan B One-Step gets nod

In separate action April 30, the FDA announced its approval of an amended application submitted by North Wales, PA-based Teva Women’s Health to market its ECP, Plan B One-Step, for use without a prescription by women age 15 and older.

With the FDA’s action, only Plan B One-Step will be available for non-prescription sale to those age 15 and above. Other brands of levonorgestrel ECPs are not included in the FDA’s April 30 approval. The ulipristal acetate ECP, ella, also remains prescription-only.

“Plan B One-Step will be available in retail outlets with an onsite pharmacy, where it generally will be available in the family planning or female health aisles to consumers 15 years of age and older within a few months,” states Denise Bradley, vice president, corporate communications of Americas Teva Pharmaceuticals.

While Plan B One-Step now will be shelved on the counter with other family planning products, it will be clearly be labeled “not for sale to those under 15 years of age *proof of age required* not for sale where age cannot be verified.” The drug also will be packaged with a product code prompting a cashier to request and verify the customer’s age. Customers who cannot provide age verification will not be able to purchase the product. In addition, Teva has arranged to have a security tag placed on all product cartons to prevent theft.

According to the FDA, Teva has indicated that it plans to educate consumers, pharmacy staff, and healthcare professionals about the product’s new status. The company also has indicated it will conduct an audit of the age verification practices after the product is approved to ensure that the age limitation is being followed, the FDA states.

The Association of Reproductive Health Professionals registered its disappointment in what it terms as “conditional” approval of access to Plan B One-Step emergency contraception for women 15 and older. “The proof-of-age requirement places an undue burden on the many women who do not have this type of identification,” reads a statement from the organization. “We encourage the FDA to approve EC for unrestricted over-the-counter access.”

Although the FDA’s action improves the accessibility of EC, the American College of Obstetricians and Gynecologists (ACOG) has reaffirmed its position that EC should be available over-the-counter (OTC) without any age restriction. Additionally, it is unclear how 15-year-olds will be able to prove age without a government identification, ACOG noted in a May 1 statement.

“The medical evidence demonstrates that EC is safe and effective in preventing pregnancy for all reproductive-age females,” the statement reads. “The College strongly encourages the FDA to reaffirm its earlier decision to approve EC for unrestricted OTC access.”