Plan B Ruling: Little Commercial Impact, Big Policy Implications
This article was originally published in The Tan Sheet
The court ruling overturning FDA's restricted distribution of the emergency contraceptive Plan B could have a number of implications for the biopharma industry - ranging from a near-term impact on confirmation of Obama administration nominees to a longer-term curbing of creative product risk management activities
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In comment among dozens posted at deadline shortly before FDA advisory panel meeting in May on HRA Pharma’s Opill proposal, Pro-Family Women says, “American women’s typical use of contraceptives, when put into real-world practice, often do not prevent pregnancy.” Other advocacy and professional groups’ comments near deadline urge approval to expand access.
HRA executives and other representatives for firm and FDA officials will make presentations about HRA’s sNDA to agency’s Nonprescription Drug and Obstetrics, Reproductive and Urologic Drugs advisory committees during a joint meeting on 9-10 May.
FDA asks its Nonprescription Drug and Obstetrics, Reproductive and Urologic Drugs advisory committees during a joint meeting on 9-10 May to recommend whether to approve HRA Pharma’s proposal for OTC switch of a daily oral contraceptive, its 0.075-mg norgestrel tablet branded Opill.