FDA & Drug Shortages

Andrea Taylor, RD, CNSC | Oley Foundation Manager of National Advocacy

On May 17, I had the privilege of addressing the US Food and Drug Administration (FDA) and other organizations on behalf of Oley members. In my opening statement, I expressed gratitude for the opportunity to speak, emphasizing that patients’ voices are often excluded when decisions are made by clinicians, industry, and government agencies.

I went on to share images from our 2023 annual conference in St. Louis, Missouri, showcasing real patients actively living their lives rather than confined to hospital beds. I then dove in with a critical issue for our members: shortages. Few outside the nutrition support community understand the complexities of parenteral nutrition (PN) or the severe impact of shortages. PN consists of at least twenty separate sterile injectable components. Even a single shortage can have significant consequences, especially given the limited or nonexistent alternative products. For instance, during a recent shortage of IV multivitamins, many patients were advised to switch to oral supplements, which can be inadequate if a person has absorption issues. For those unable to take anything orally, reducing IV multivitamin days to conserve stock became an upsetting reality.

Even a single shortage can have significant consequences, especially given the limited or nonexistent alternative products.

When a life-sustaining component is in shortage, the emotional toll on patients and caregivers is often overlooked. Many on PN have struggled to reach a point of stability, or are still fighting, so if/when PN components go into shortage, it can feel overwhelmingly scary and/or frustrating.

Unfortunately, the available literature on patient harm and long-term effects of these shortages is limited. I question if it is related to the lack of awareness among patients and some clinicians of the event-reporting process. Oley hopes to change this.

During the discussion period, I asked the FDA about prioritizing life-sustaining injectables for healthcare facilities during shortages, rather than diverting them to non-essential uses like IV spas. Their responses indicated this hadn't previously been considered, and I expressed Oley's interest in advocating for such policies.

This opportunity to address the FDA and other stakeholders on behalf of Oley's members was a profound experience. By sharing real-life perspectives and advocating for the prioritization of life-sustaining treatments during shortages, we hope to elevate awareness and drive meaningful change. Oley remains committed to amplifying patient voices in healthcare decision-making, ensuring that the challenges and needs of those requiring nutrition support are not only understood, but also prioritized in policy discussions and initiatives.