Congress granted the US Food and Drug Administration (FDA) the authority to regulate drugs over six decades ago. In 1962, the FDA was further empowered to mandate that drug companies demonstrate the effectiveness of their products. Mifepristone, a key component in medication abortion in the US, received initial approval in 2000, but the regulatory landscape surrounding its usage has evolved since then.
For a drug to secure FDA approval, manufacturers must adhere to stringent criteria proving the drug's safety and efficacy. This involves comprehensive data from laboratory experiments, pre-clinical trials, and clinical studies.
Timeline of FDA Regulations on Mifepristone:
2000: Mifepristone was first sanctioned for medical pregnancy termination under specific restrictions. It was limited to administration up to seven weeks of gestation and could only be prescribed by physicians in-person.
2016: The FDA broadened the scope of mifepristone following a submission by Danco Laboratories, the drug's sponsor, to alter its usage guidelines. After scrutinizing 16 years of mifepristone data and considering international prescription practices and professional guidelines, the FDA permitted clinicians to prescribe the drug up to 10 weeks into pregnancy. This decision was supported by data from 20 additional studies assessing the drug's safety and efficacy.
2021: In response to the Covid-19 pandemic and research on the safety and efficacy of telehealth services, the FDA removed the in-person dispensing prerequisite. Following a thorough evaluation of available data on safety and effectiveness, and drawing on the experiences of millions of individuals who had used the drug, the FDA made this change permanent in 2023 and eliminated the in-person dispensing requirement.
