Federal Approval of Over-the-Counter Birth-Control Pills

Author: Erika Cheung


Summary 


Women have a right to contraception, regardless of circumstance. But this right has recently come under threat. Starting in 2016, multiple federal and state regulations pulled critical funding to reproductive and family-planning services. The COVID-19 crisis amplified the challenges Americans face while attempting to receive basic healthcare resources like birth-control pills. To reverse this worrying trend and ensure universal access to contraception in the United States, the federal government should approve over-the-counter (OTC) birth-control pills — thereby removing the need for a prescription to protect women’s health and prevent unintended pregnancies.


Specifically, the Biden-Harris Administration should commission the Food and Drug Administration (FDA) to create an OTC Monograph for oral contraceptives (i.e., birth-control pills). An OTC Monograph is a rulebook established by the FDA that gives specific instructions on the manufacture, distribution and marketing of non-prescription, OTC drugs. Circumstances are right for this action. 2020’s Coronavirus Aid, Relief, and Economic Security (CARES) Act established the OTC Monograph Reforms, creating a new and efficient process to produce OTC drugs. The CARES Act also provided the FDA’s Department of Non-prescription Drugs with $110 million over five years1 to produce more OTC drugs. Oral contraceptives are ideal OTC candidates, having been proven safe and effective for 60 years. It is time for the United States to follow the example set by more than 100 countries to date and provide women with OTC birth-control pills.


Download PDF


About the Author


Erika Cheung is the Executive Director of Ethics in Entrepreneurship, a non-profit organization with the mission to embed ethical questioning, culture, and systems in start-up ecosystems worldwide. Erika began her career working as a medical researcher in the biotechnology industry, and is most famously known for being a key whistle-blower reporting the medical-diagnostic company Theranos to health regulators. Erika went on to help launch a technology accelerator in Hong Kong supporting early-stage technology investments across the Asia-Pacific (APAC) region. She continues to advise and support the development of biotechnology and healthcare initiatives across the APAC region.