Beyond the Prescription Pad: Over-the-Counter Oral Contraceptive Gains FDA Approval - Frankly Speaking Ep 342

Credits: 0.25 AMA PRA Category 1 Credit™ CME/CE Information and Claim Credit: https://www.pri-med.com/online-education/podcast/frankly-speaking-cme-342

Overview: In July of 2023, the FDA made a monumental decision to approve Opill, marking the first time an oral contraceptive will be made available without a prescription. The inaugural over-the-counter oral contraceptive is a progesterone-only pill. Join us to discuss the underlying rationales driving this decision and the prospective implications it might have on medical practice as well as women’s health.

Episode resource links:

Biggs, AM, Ralph, L, Morris, N, Ehrenreich, K, Perritt, J, Kapp, N, Blanchard, K, White, K,  Barar, Grossman, RD.A cross-sectional survey of U.S. abortion patients’ interest in obtaining medication abortion over the counter, Contraception, Volume 109, 2022, Pages 25-31, ISSN 0010-7824,https://doi.org/10.1016/j.contraception.2022.01.010.

Chen, Q.J. Xiang, W.P. Zhang, D.K., Wang, R.P. Luo, Y.F. Kang, J.Z. Cheng, L.N. Efficacy and safety of a levonorgestrel enteric-coated tablet as an over-the-counter drug for emergency contraception: a Phase IV clinical trial, Human Reproduction, Volume 26, Issue 9, September 2011, Pages 2316–2321, https://doi.org/10.1093/humrep/der181

Raine, TR; Ricciotti, N; Sokoloff, A; Brown, B; Hummel, A; Harper, C. An Over-the-Counter Simulation Study of a Single-Tablet Emergency Contraceptive in Young Females. Obstetrics & Gynecology 119(4):p 772-779, April 2012. | DOI: 10.1097/AOG.0b013e31824c0aed

https://www.fda.gov/news-events/press-announcements/fda-approves-first-nonprescription-daily-oral-contraceptive

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/017031Orig1s041SumR.pdf

Guest: Susan Feeney, DNP, FNP-BC, NP-C Music Credit: Richard Onorato