FDA Lowers Plan B One-Step Age Restriction To 15
This article was originally published in The Tan Sheet
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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.
FDA has heard from some manufacturers that additional time is needed to meet all of the requirements, “especially during the COVID-19 pandemic.” Prior to the pandemic, agency announced enforcement discretion during 2020 for compliance by firms with more than $10m in annual sales.
ODS Director Steven Tave says violative manufacturing processes and products remain common not because FDA isn’t enforcing its regulations. “I applaud those who stand behind their products, but can you stand with the same conviction behind every product on the market?” he said at regulatory summit organized by trade groups.