FDA Identifies Panhematin as an "Essential Medicine"

  • Friday, November 13, 2020

In early August, an Executive Order 13944 titled: Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs are Made in the United States, was issued to the Food and Drug Administration (FDA). This order directed the FDA to identify a list of essential medicines that are medically necessary to have available at all times in the amount adequate to serve patient needs and in the appropriate dosage forms. 

Panhematin (Hemin for Injection) was listed as one of the 223 drug and biological product essential medicines. The goal of this order is to secure sufficient and reliable long-term access to these treatments.

As we battle the current pandemic, this list of essential medications will protect against a future public health emergency. In collaboration with the Department of Health and Human Services (HHS), the FDA is also charged with addressing any supply chain issues for the list of essential medications.

The list, which was published on October 30, includes medicines that are most needed in US acute care medical facilities, which specialize in short-term treatment for severe injuries or illnesses, and urgent medical conditions. The essential medicines identified by the FDA are the ones most needed to meet certain criteria, such as ones that are necessary to address life-threatening medical conditions and that are used to stabilize patients.

For more information: https://www.fda.gov/news-events/press-announcements/fda-publishes-list-essential-medicines-medical-countermeasures-critical-inputs-required-executive

If you are experiencing any issues accessing Panhematin, please contact the APF at info@porphyriafoundation.org or 866-APF-3635.