The FDA recently updated its rules to remove the in-person dispensing requirement for a well-known abortion drug. Read this blog post to understand how rule changes related to the COVID-19 pandemic influenced the FDAs decision, what modifications were made, and how healthcare providers that are LegitScript-certified can stay abreast of trends and maintain compliance.
How the COVID-19 Pandemic Influenced the FDA’s Decision
In January 2023, the US Food and Drug Administration (FDA) updated the Risk Evaluation and Mitigation Strategy (REMS) for mifepristone — a drug commonly used for abortion. Part of the rule change includes updates to the dispensing requirements for mifepristone which, prior to the COVID-19 pandemic, was only available through in-person dispensing.
🚩 A Risk Evaluation and Mitigation Strategy (REMS) is a program designed by the FDA to ensure drug safety. The REMS program outlines medication use behaviors, and stipulations for its administration to patients. Only a select few medications are subject to REMS.
Four months into the global COVID-19 pandemic, the country was on lockdown and citizens were encouraged to stay in their homes. It was during this time, at the height of 2020, that The American College of Obstetricians and Gynecologists (ACOG) sued the FDA alleging that the in-person dispensing requirement was “jeopardizing the health and lives of patients and clinicians” during the pandemic.
In 2021, after conducting a comprehensive safety review of the issue, the FDA moved to modify the REMS Program to reduce burden on the healthcare delivery system and to ensure the benefits of the product outweigh the risks, by suspending the in-person dispensing requirement through the duration of the COVID-19 public health emergency declaration. This change opened up the possibility of the dispensing of mifepristone via telemedicine where such practice is not prohibited by state law.
What modifications were made to the mifepristone REMS Program in January 2023?
The REMS Program was amended in 2023 in two main ways. First, the FDA permanently removed the in-person dispensing requirement for certified providers and pharmacies prescribing mifepristone or Mifeprex. Second, the FDA added a requirement that pharmacies dispensing these drugs are certified under the mifepristone REMS Program.
The FDA has warned the public about buying abortion medication online without properly vetting the dispensing pharmacy: “The FDA does not recommend purchasing mifepristone outside of the mifepristone REMS Program – e.g. buying it online or personally transporting it from a foreign country.” LegitScript tracks the online landscape for rogue internet pharmacies selling prescription drugs without a prescription, or ones selling drugs that are counterfeit or substandard and which may pose a risk to consumers.
LegitScript recommends looking up a pharmacy or telemedicine provider on legitscript.com to see if it is LegitScript-certified. Healthcare providers that are certified by LegitScript have proven that they operate safely and in compliance with our high standards and with all applicable laws in the jurisdictions where they operate.
Want to learn more about LegitScript’s Healthcare Merchant Certification?
LegitScript helps pharmacies, telemedicine companies, and other healthcare-related businesses stand out from the crowd, prove their safety and compliance, and take advantage of advertising on major search engines and social media platforms. We also help payment service providers and internet platforms that work with healthcare merchants ensure that they are operating in compliance. That’s why major payments and internet companies require LegitScript certification as part of their policies.
The healthcare space is complex, and LegitScript’s team of regulatory experts has been tracking developments regarding the recent FDA REMS Modification as well as changes in law as a result of the Supreme Court’s recent decision in Dobbs v. Jackson Women’s Health Organization. Through our Healthcare Merchant Certification, we help our companies stay abreast of trends so that they can grow their business while staying in compliance.
Want to learn more about LegitScript Certification? Contact us or download our Healthcare Certification Primer to answer common questions like:
- What is the cost based on my business model?
- What documents do I need to get started?
- Are there ways to help expedite my review?
