Guttmacher Expert Testimony in Support of Approving Over-the-Counter Status for Opill Without an Age Restriction

Megan L. Kavanaugh, Guttmacher Institute

Oral testimony at the Food and Drug Administration’s Open Public Hearing to discuss Opill (sNDA 017031/S-041)​ by Megan Kavanaugh, DrPH​, Principal Research Scientist, Guttmacher Institute​ 

Hello. My name is Megan Kavanaugh, and I am a Principal Research Scientist at the Guttmacher Institute, an independent, not-for-profit organization focusing on reproductive health research and policy analysis in the United States and globally.  

I have no financial disclosures to make. 

I and my colleagues have conducted extensive research examining contraception in the United States, and evidence generated by us and many other researchers supports the safety of contraception and its centrality in ensuring people of all ages can achieve reproductive health, autonomy and dignity. 

Today, I want to make five important points about the body of evidence from the behavioral health field that supports a switch to over-the-counter status for OPill that is inclusive of all ages.  

One, young people may have the most to gain from over-the-counter access to contraception. Adolescents experience unique barriers to accessing contraception within the health care system, including confidentiality concerns and increased stigma, which would be minimized with broader, over-the-counter access to contraception. 

Two, despite these barriers, most adolescents use contraceptives at both first sex and most recent sex. The most recent available data indicate that 77% of females and 91% of males aged 15–19 reported contraceptive use the first time they had sexual intercourse, and 91% of females and 94% of males reported that they or their partner had used contraception the last time they had sexual intercourse.  

Three, the science is clear that recent declines in US adolescent pregnancies that occurred too early or were unwanted can be attributed primarily to increases in adolescent contraceptive use. 

Four, levels of sexual activity among adolescents under age 13 are low and have been declining over time. About 4% of adolescents aged 13 and under reported being sexually active in 2015, down from 5.6% in 2013.  

Five, there is significant evidence from dozens of well-conducted studies that increased availability of contraception does not increase sexual activity among young people. Further, between 2007 and 2014, more adolescents were using contraceptives, they were using more effective methods and they were using them more consistently—all while adolescent sexual activity rates remained unchanged. 

In short, robust scientific evidence very much supports that over-the-counter access for OPill would have significant benefits for public health and individuals' well-being and should be inclusive of people of all ages. Any age restriction would be counterproductive, as adolescents face both greater chances of unwanted pregnancy, as well as potentially greater ramifications of those pregnancies, than adults. I urge the FDA to consider the most current and accurate data available in making an evidence-based decision on making Opill available over the counter without an age restriction; the science overwhelmingly supports a vote of “yes.” 

Thank you again for the opportunity to speak today. 

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