FDA approves EC pill without prescription

The US Food and Drug Administration (FDA) has approved the Plan B One-Step levonorgestrel pill for emergency contraception (EC) without prescription for women aged 15 years and older, although proof of age must be provided at the time of purchase.

The FDA says that its approval of Teva Women’s Health’s amended application to make the drug available over-the-counter to all women of reproductive age is independent of an April 5 federal court ruling that ECs be made available in pharmacies to women without age restriction or a prescription.

In that ruling, Judge Edward R. Korman of the US District Court for the Eastern District of New York had concluded that restricting ECs for girls aged younger than 17 years was not based on scientific evidence. The action effectively overruled a decision by the US Department of Health and Human Services in 2011 that restricted young girls' access to drugs that prevent pregnancy after unprotected sexual intercourse. The FDA had 30 days to respond.

Plan B One-Step now will 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 product will be placed in family planning and women’s health sections of retail outlets with an on-site pharmacy and will be available for purchase any time the retailer is open even if the pharmacy is not. The packaging will contain a product code that prompts a cashier to request the customer’s identification to verify age at the time of purchase and also a security tag to prevent theft.

FDA says its decision is based on actual use studies and comprehension data showing that girls and women aged 15 years and older can use ECs properly without the intervention of a health care provider. However, the agency's approval applies only to Plan B One-Step. The court's ruling would have applied to all ECs that contain levonorgestrel.