WASHINGTON (CBS) – The U.S. Department of Health and Human Services (HHS) blocked a plan on Wednesday to make the morning after pill available to young teens without a prescription.
Teva Women’s Health, Inc. had sought to allow the “morning after” pill, also known as Plan B One-Step, be sold to anyone over the counter. The pill can prevent pregnancy if taken soon after unprotected sex.
Despite a recommendation for approval from the FDA, the HHS denied the request, saying that while “the science has confirmed the drug to be safe and effective with appropriate use,” there was not “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,” said Sec. Sebelius in a press release.
Sec. Sebelius instead directed the FDA to issue a “response letter” back to Teva denying their request.