Will Influences Behind US FDA's Delayed Approval For OTC Plan B Also Shadow ‘Plan A’ Switch?
FDA history with emergency contraceptives and opioid overdose antidote naloxone doesn’t assure Jeffrey Singer, Valley Surgical Clinics founder and advocate for making more drugs available OTC, the agency will approve HRA Pharma's NDA for OTC 0.075-mg norgestrel.
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FDA decision on Perrigo subsidiary’s proposal for first US OTC daily oral contraceptive is extended 90 days with the postponement of an advisory panel meeting. Agency requested additional information related to OTC switch application of 0.075-mg norgestrel initially submitted in July.
Consumer health product firms’ vistas include challenges of supply chain disruptions lingering from pandemic’s impact as well as potential for marketplace restrictions as additional varieties of the novel coronavirus spread. Clouds also include shifts in consumer spending, increases in costs caused by inflation and foreign exchange headwinds as the value of the US dollar strengthens against other currencies.
“It’s going to be industry people like me that have to make a decision that we're going to spend the time, we're going to spend the money to work with FDA for the many years it takes generally speaking to get these things approved,” says Femasys CEO Kathy Lee-Sepsick.