Premier Inc. Supports FDA, DEA Reforms and Regulatory Waivers to Counter Drug Shortages

Premier Inc. today provided the U.S. Food and Drug Administration (FDA) and the U.S. Drug Enforcement Administration (DEA) with a list of reforms and regulatory waivers that the company believes should be extended beyond the COVID-19 pandemic and made permanent thereafter in order to prevent drug shortages.

“During the height of the COVID-19 pandemic, we saw demand for many common pharmaceuticals surge by an average of more than 150 percent,” said Blair Childs, Premier’s Senior Vice President of Public Affairs. “Waivers from the FDA and DEA cleared away cumbersome barriers and helped providers manage surges in demand to avoid drug shortages. Lessons learned during the pandemic response demonstrate that these flexibilities could be implemented safely and were effective in mitigating drug shortages that otherwise could have been detrimental to patient care. The Administration should act on all these recommendations, easing regulatory burden and improving options for patients.”

Specifically, Premier recommends to the FDA that 503B compounding facilities be allowed to continue producing specific drugs that are not on the drug shortage list based on specific criteria, such as a short-term or regional shortages or demand surges for certain dosage strengths and/or packaging sizes. This waiver proved particularly helpful during the pandemic, as it allowed 503B compounders to quickly and seamlessly fill capacity gaps and alleviate spot shortages before they became severe enough to spread nationwide and make it onto the FDA drug shortage list.