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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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.
Sponsors in both chambers amplify the FDA’s role announcing the legislation, saying the bills intend to “maintain the FDA’s sole authority to determine the safety and efficacy of drugs and make them available over-the-counter without a prescription.”