WASHINGTON — U.S. Department of Health and Human Services Secretary Kathleen Sebelius has overruled a decision by the Food and Drug Administration that would have allowed women under age 17 to buy the Plan B One-Step morning-after pill without a prescription.
In a statement released Wednesday, Sebelius said she has directed the FDA to issue a complete response letter denying the supplemental new drug application (SNDA) by Teva Women’s Health Inc.
"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," Sebelius said in her statement. "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 move marks a setback for Teva Women’s Health, which sought to lift the age limit for Plan B One-Step so the emergency contraceptive could be sold OTC to all females of child-bearing potential. Teva formally made that request for Plan B One-Step in February. The pill will still be available without a prescription to women age 17 and older.
FDA Commissioner Margaret Hamburg said in a statement Wednesday that she agreed with the agency’s Center for Drug Evaluation and Research (CDER) that "there is adequate and reasonable, well-supported and science-based evidence that Plan B One-Step is safe and effective and should be approved for nonprescription use for all females of child-bearing potential.
"However, this morning I received a memorandum from the Secretary of Health and Human Services invoking her authority under the Federal Food, Drug, and Cosmetic Act to execute its provisions and stating that she does not agree with the [FDA’s] decision to allow the marketing of Plan B One-Step nonprescription for all females of child-bearing potential," Hamburg stated.
Sebelius said it is "common knowledge" that there are significant cognitive and behavioral differences between older adolescent girls and the youngest girls of reproductive age.
"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," she explained in her statement. "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."
Teva issued a statement commending the FDA for its recommendation and disappointment over the HHS decision. The company said it was awaiting formal notice from HHS before determining its next steps.
