How the FDA Can Help Prevent Drug Shortages Without Disrupting COVID-19 Vaccine Manufacturing
The U.S. government and Operation Warp Speed are in the process of producing and distributing COVID-19 vaccines. While this vast private/public program is moving as quickly as possible to bring vaccines to Americans and end the pandemic, the U.S. Food and Drug Administration (FDA) also has procedures in place to help avoid shortages in the production of other life-saving and medically necessary medicines that are not related to the novel coronavirus, including treatments for eye diseases and other complex health conditions; treatments that are critical for patients who live with additional medical conditions. The information provided in this brief provides patients with the information needed should a change in treatment availability occur. As events evolve, Prevent Blindness will update this page to keep patients informed in their treatment decisions.
Treatment delays, even temporary, can be detrimental to a patient’s health. The U.S. Food and Drug Administration (FDA) can take action to help prevent drug shortages and protect treatment access without compromising the COVID-19 pandemic response.
The CARES Act expands the FDA authority to address drug shortages, clarifying that the FDA will prioritize drug applications or inspections to prevent a drug shortage.
According to the CARES Act, FDA shall not only expedite, but “prioritize” applications or inspections that could mitigate or prevent a drug shortage. Under its authority, FDA can prioritize the review of relevant data, expedite lot release, and develop risk mitigation strategies to allow individual batches of a drug to be released even when quality assurance requirements are not met.
FDA is authorized to take actions necessary to avoid drug shortages and has traditionally, in the past, exercised its regulatory discretion to ensure patients are able to access the drugs they need.
In drug shortages reports published between 2013 and 2019, FDA notes that it has in each fiscal year “exercised temporary regulatory flexibility and discretion with respect to the continued distribution of a drug product to mitigate or resolve a drug shortage while FDA reviewed a supplement/proposed change to address a problem with the drug product.”