The FDA announced on Tuesday that it lowered to 15 the age at which women can buy Teva’s Plan B One-Step (levonorgestrel) emergency oral contraceptive and also allowed the drug to be available over-the-counter without a prescription. Previously, only those aged 17 or older could obtain the emergency oral contraceptive without a prescription.
In December 2011, the US regulator declined to approve an application from Teva to remove age restrictions on Plan B One-Step, which was cleared in an over-the-counter version in 2006 for women at least 18 years old. The FDA had planned to broaden approval of Teva’s drug, but the US Department of Health and Human Services over-ruled the agency amid concerns that younger women should be required to consult with a healthcare provider before being allowed to use the product. However, a federal judge recently ruled that there should be no age restrictions and gave the regulator 30 days to act.
The agency noted that it reached the decision to expand approval independent of the court case. "Research has shown that access to emergency contraceptive products has the potential to further decrease the rate of unintended pregnancies in the United States," remarked FDA Commissioner Margaret A. Hamburg, adding that "the data reviewed by the agency demonstrated that women 15 years of age and older were able to understand how Plan B One-Step works, how to use it properly, and that it does not prevent the transmission of a sexually transmitted disease."
Teva noted that the packaging on Plan B One-Step will now be altered to state that it is "not for sale to those under 15 years of age." If age-verification cannot be performed, or if the intended customer does not meet the age requirement, the sale cannot proceed, the drugmaker added. As part of the approval, Teva has also indicated its willingness to conduct an audit of the age verification practices to ensure that the age limitation is being followed, the FDA noted.
The agency also remarked that the decision to expand approval of Teva’s Plan B One-Step does not affect the prescription status of the other emergency oral contraceptive drugs marketed in the US.