AMA Shares OTC Birth Control Diagnosis With FDA
American College of Obstetricians and Gynecologists proposed amending existing AMA policy in anticipation of Perrigo’s HRA business submitting NDA to FDA for OTC switch of progestin-only daily oral contraceptive the end of 2022.
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Whether FDA handling of HRA Pharma’s OTC switch NDA for 0.075-mg norgestrel continues along normal arc is question which prompts concerns. “I hope that they don't make the same mistakes that were made back on the Plan B,” says Susan Wood, an associate professor at George Washington University School of Public Health and a former FDA office director.
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.
HRA has worked with Ibis Reproductive Health, which supports the Free the Pill advocacy group, to conduct research for a norgestrel switch NDA.