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SILVER SPRING, Md. — Food and Drug Administration commissioner Margaret Hamburg on Wednesday issued a public statement that the agency was prepared to approve Plan B as a nonprescription medication, but reversed that decision following a directive from the Department of Health and Human Services Wednesday morning.
"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 agency’s decision to allow the marketing of Plan B One-Step nonprescription for all females of child-bearing potential," Hamburg stated. "Because of her disagreement with the FDA’s determination, the secretary has directed me to issue a complete response letter, which means that the supplement for nonprescription use in females under the age of 17 is not approved."
Plan B One-Step will remain on the market with its dual prescription/nonprescription status — available from behind the pharmacy counter to women over the age of 17 years and by prescription only for women younger than 17 years.
Following a review of consumer usage studies, FDA's Center for Drug Evaluation and Research determined that the product was safe and effective in adolescent females, that adolescent females understood the product was not for routine use and that the product would not protect them against sexually transmitted diseases. Additionally, the data supported a finding that adolescent females could use Plan B One-Step properly without the intervention of a healthcare provider.
"It is our responsibility at the FDA to approve drugs that are safe and effective for their intended use based on the scientific evidence," Hamburg stated. "CDER experts, including obstetrician/gynecologists and pediatricians, reviewed the totality of the data and agreed that it met the regulatory standard for a nonprescription drug and that Plan B One-Step should be approved for all females of child-bearing potential."
"I have carefully considered FDA's Division Director Summary Review of Regulatory Action, dated Nov. 30 2011, for the supplement application, which represents the position of the FDA and recommended approval of the application," HHS secretary Kathleen Sebelius wrote in a letter addressed to Hamburg. "Based on my view, I have concluded that the data submitted for this product do not establish that prescription dispensing requirements should be eliminated for all ages."