HHS instructs FDA to decline proposal to move Plan B from BTC to OTC
WASHINGTON — The Department of Health and Human Services on Wednesday denied a request made by Teva Pharmaceuticals to relax merchandising restrictions for the emergency contraceptive Plan B. Presently, Plan B can be sold without a prescription to women older than 17 years old but only in a pharmacy and from behind the pharmacy counter. Women younger than 17 years require a prescription to acquire Plan B.
"Because I do not believe enough data were presented to support the application to make Plan B One-Step available over the counter for all girls of reproductive age, I have directed [the Food and Drug Administration] to issue a complete response letter denying the supplemental new drug application by Teva Women’s Health," stated HHS secretary Kathleen Sebelius.
"This application sought to make Plan B One-Step available over the counter for all girls of reproductive age," she stated. "The science has confirmed the drug to be safe and effective with appropriate use. However, the switch from prescription to over the counter for this product requires that we have enough evidence to show that those who use this medicine can understand the label and use the product appropriately. I do not believe that Teva’s application met that standard. The label comprehension and actual use studies did not contain data for all ages for which this product would be available for use."
The average age of the onset of menstruation for girls in the United States is 12.4 years, Sebelius noted. However, about 10% of girls are physically capable of bearing children by 11.1 years of age. "It is common knowledge that there are significant cognitive and behavioral differences between older adolescent girls and the youngest girls of reproductive age," Sebelius said. "If the application were approved, the product would be available, without prescription, for all girls of reproductive age."