November 18, 2022
“Joint Meeting of the Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive and Urologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments.”
11/3/2022 Submitted to the FDA as written testimony in response to:
“Joint Meeting of the Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive and Urologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments”
Comment Tracking Number: la1-nln7-ta6n
The Society for Adolescent Health and Medicine (SAHM) joins other major professional medical organizations, including the American College of Obstetricians and Gynecologists, the American Academy of Family Physicians, and the American Medical Association, in supporting over-the-counter access to oral contraceptive pills. Oral contraceptive pills are a safe and effective method of contraception, and SAHM encourages the Food and Drug Administration to approve their over-the-counter use without an age restriction.
The ability to determine if and when to have children is a fundamental human right of all people, including adolescents and young adults (AYAs). Access to contraception is paramount to actualizing this right and to the health and well-being of AYAs. AYAs in particular face barriers to contraceptive access, including obstacles related to clinician availability, transportation, confidentiality, insurance, and cost. Over-the-counter access to oral contraceptives has the potential to reduce these barriers.
Contraceptive pills are available over-the-counter in more than 100 countries and have been used safely by millions of people around the world.(1) The risk of serious adverse events such as venous thromboembolism (VTE) is very low, especially for AYAs, and lower than the VTE risk during pregnancy and the postpartum period.(2,3) Past studies of women, including AYAs, indicate they can accurately self-screen for medical conditions that may preclude the use of oral contraceptives and should be discussed with a clinician before deciding to use the pill.(4,5) No in-person laboratory tests or physical examinations are necessary to determine medical eligibility to start oral contraceptives, making them an appropriate choice for over-the-counter status.
Any oral contraceptive approved for over-the-counter use should be available without age restrictions as data shows that most adolescents have the cognitive maturity to make decisions about their health care.(6) Additionally, there is strong consensus among AYA health professionals that allowing adolescents to make decisions about their sexual and reproductive health is critical for the health of individual adolescents, is part of the normal developmental process, and promotes public health.(7-10) SAHM further emphasizes that any oral contraceptive approved for over-the-counter use should be widely accessible and available as well as fully covered by insurance, as required by current regulations prohibiting cost-sharing for contraceptives.
Oral contraceptive pills are safe, effective, and have the potential to increase access to contraception for AYAs. SAHM urges the Food and Drug Administration to approve over-the-counter oral contraceptives without delay.
SAHM, founded in 1968, is a nonprofit multidisciplinary professional society of 1,200 members committed to the promotion of health, well-being and equity for all AYA. Through education, research, clinical care and advocacy, SAHM enhances public awareness of adolescent health issues among families, educators, policy makers, youth-serving organizations, and students in the field.
1. Grindlay K, Burns B, Grossman D. Prescription requirements and over the counter access to oral contraceptives: a global review. Contraception. 2013;88(1):91-96.
2. Lindegaard O, Lokkegaard E, Svendsen AL, Agger C. Hormonal contraception and risk of venous thromboembolism: a national follow-up study. BMJ. 2009;339:b2890.
3. Heit JA, Kobbervig CE, James AH, Petterson TM, Bailey KR, Melton LJ III. Trends in the incidence of venous thromboembolism during pregnancy or postpartum: a 30-year population-based study. Ann Intern Med. 2005;143(10):697-706.
4. Grossman D, Fernandez L, Hopkins K, Amastae J, Garcia SG, Potter JE. Accuracy of self-screening for contraindications to combined oral contraceptive use. Obstet Gynecol. 2008;112:572-578
5. Williams R, Hensel D, Lehmann A, Sarin T, Shew M, Ott M. Adolescent self-screening for contraindications to combined oral contraceptive pills. Contraception. 2015;92:380.
6. Weithorn LA, Campbell SB. The competency of children and adolescents to make informed treatment decisions. Child Dev. 1982;53(6):1589-1598.
7. Ford C, English A, Sigman G. Confidential health care for adolescents: position paper of the Society for Adolescent Medicine. J Adolesc Health. 2004;35(2):160-167.
8. American Academy of Pediatrics Committee on Adolescence; Braverman PK, Adelman WP, Alderman EM et al. Contraception for adolescents. Pediatrics. 2014;134(4):e1244-e1256.
9. American College of Obstetricians and Gynecologists Committee on Adolescent Health Care. ACOG Committee Opinion: Confidentiality in adolescent health care. Obstet Gynecol. 2020;135(4):e171-e177.
10. American Academy of Family Physicians. Policy: Adolescent health care, confidentiality. 2020. Accessed 10/26/22. https://www.aafp.org/about/policies/all/adolescent-confidentiality.html#Adolescent%20Health%20Care,%20Confidentiality
Authored by members of the SAHM Sexual and Reproductive Health (SRH) Committee:
Alana Otto MD MPH (lead author)
Loris Y. Hwang MD MS (SRH Committee Chair)
Cherie Priya Dhar MD
David Klein MD MPH
May Lau MD MPH
Kathleen Tebb PhD
Ellie Vyver MD
Reviewed by members of SAHM:
John Santelli MD MPH (past president of SAHM)
Laura K Grubb MD MPH (Advocacy Committee Chair)
Endorsed by the SAHM Executive Board