Plan B One-Step Full OTC Access Has FDA Pediatric Advisors’ Support
This article was originally published in The Tan Sheet
Data from FDA and the American College of Obstetricians and Gynecologists show “it is outrageous it is not available for women of all ages over the counter,” a Pediatric Advisory Committee member says. The committee lauds FDA for grounding its pediatric safety review of Plan B One-Step in science.
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FDA found only 13 reports of serious pediatric AERs following ingestion of original two-dose Plan B or one-dose Plan B One-Step. In a review released Jan. 27, Office of Surveillance and Epidemiology officials said the data do not causally link the majority of pediatric AERs definitively to the drug.
HHS Secretary Sebelius says Teva must show more evidence of how young adolescent females would use Plan B One-Step as an OTC. But obtaining such clinical data for the emergency contraceptive – in excess of what FDA already needed to approve it – appears nearly impossible, experts say.
J&J reports worldwide consumer sales dipped 0.6% to $3.6 billion despite retailers buying more upper respiratory and analgesic products to prepare for the cough and cold season. But in key OTC categories the firm is regaining market share it lost when its iconic brands were temporarily not available.