Background: Current regulations restrict access to medication abortion and contribute to the perception that women cannot safely take medication abortion pills (mifepristone and misoprostol) on their own without clinician supervision. However, these drugs meet many of the Food and Drug Administration (FDA) criteria for being available over the counter (OTC). Medication abortion is safe, has a low toxicity profile, is not addictive, and women are already using them safely on their own in many parts of the world. We propose to address the gaps in research essential to demonstrating that medication abortion is appropriate for OTC availability.
Methods: We will conduct a series of investigations (label comprehension and self-selection studies) to assess whether women of varying literacy levels can understand a Drug Facts Label, assess gestational age as eligible and rule out other contraindications for medication abortion without clinician involvement. We will also plan an actual use study for an OTC medication abortion product.
Proposed analysis: Following the model of the Oral Contraceptives OTC Working Group, we plan to use research results to build consensus among advocates, clinicians and researchers in the reproductive health, rights and justice field in support of OTC access to medication abortion, and to encourage a pharmaceutical company to move forward with an OTC application to the FDA. In the short term, these efforts will help support a wide variety of efforts aimed at improving access to medication abortion. In the long term, FDA approval of an OTC mifepristone-misoprostol product would dramatically increase access to medication abortion nationwide and could have global implications.