FDA Releases Report

Drug shortages across the U.S. are plaguing health systems with increases costs, subpar patient care and panic to patients and families, who desperately wait. 

It’s an issue the U.S. Food & Drug Administration says is a “hidden epidemic”, addressed with a release of an extensive report, which outlines the root causes of drug shortages, and the FDA’s potential solutions. 

Though Congress called on the FDA to investigate more than a year ago, the release of the report was ironically on the tail of national news about a pediatric cancer critical drug shortage. Vincristine, a generic chemotherapy, which is used to treat more than 12 pediatric cancers, was announced on shortage after Teva backed out of production due to a “business decision”, leaving Pfizer as the sole provider in October 2019. It sent families into frenzy, and placed healthcare providers in the unsettling position of prioritizing patients with their existing supply. 

Angels for Change founder, Laura Bray, is determined to help solve the national drug shortage crisis.  

“If medical technology exists to save of lives, patients must have access to that technology.” according to Bray. 

The FDA reports that 86% of doctors have had to move away from known protocols due to drug shortages. In addition, nine out of the 11 chemotherapy drugs used to treat acute lymphocytic leukemia have been on shortage in the last decade. 

With this data, Bray and Angels for Change will advocate for patients and build public awareness of this hidden crisis. When the vincristine drug shortage issue surfaced, Bray and her team focused on extending communications from the FDA and Pfizer, who delivered a solution within days to hospitals waiting for supply. In addition, Bray advocated for families, whose hospitals were still delaying from misinformation. Through this experience Brays says, “While the Vincristine crisis is alleviated for now, with a single-source provider, it’s far from solved.”

Reasons for drug shortages are complex. Through Angels for Change dedicated research, the FDA report and active participation in FDA’s drug shortage stakeholder engagement team, Bray says, “The solutions to prohibit what happened to Abby twice, so far in her treatment, from happening to others, need support for all stakeholders. We need to gather around the same table.”

According the FDA report, potential solutions include identifying the collective harms of drug shortages, transparency in the private sector and incentives for quality management to drug manufacturers. 

Bray says, “Angels for Change supports all movement towards solving the drug shortage crisis.”