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FDA releases a Q&A with the Drug Shortage team leader from the Center for Drug Evaluation and Research.
In a conversation posted on FDA.gov, Emily Thakur, team leader of the Drug Shortage staff at the Center for Drug Evaluation and Research (CDER), clarifies some confusion regarding the definition of drug shortages and what FDA is doing to prevent them.
According to Thakur, FDA defines drug shortages as “a period of time when the demand or projected demand for a medically necessary drug in the United States exceeds its supply.” Projected demand is estimated based on information from health data, supplier information, and US healthcare transactions.
FDA’s definition of drug shortages, however, differs somewhat from the American Society of Health-System Pharmacists (ASHP), which considers a drug “to be in shortage once the shortage is verified with manufacturers, regardless of whether the product is or is not medically necessary. They also consider a drug to be in shortage when supply issues affect how a pharmacy prepares or dispenses a drug product, or influence patient care when prescribers must use an alternative therapy.”
These differences do not impact the availability of drugs, however, according to Thakur. FDA does not consider a product to be in shortage if “one or more manufacturers are able to supply enough of the product to meet the demand.” ASHP’s drug shortage website, however, lists which manufacturers have a drug available and which ones do not. A product listed on ASHP’s website may be available from other manufacturers. “The numbers and information from ASHP are valid; they track availability-but they do not serve the same purpose as FDA,” says Thakur.
Cause and prevention
Thakur states that more than half of drug shortages are the result of quality or manufacturing issues. Other causes of drug shortages include production delays caused by raw materials or other supplier components, discontinuation of products to make way for new drugs, and a reduction in production lines. And according to Thakur, FDA cannot force a manufacturer to make more of a drug or determine how and where a drug can be distributed.
The Food and Drug Administration Safety and Innovation Act (FDASIA) has helped the drug shortage situation by requiring manufacturers to report shortages to FDA, according to Thakur. “This has resulted in additional early notifications to the FDA about potential shortages, and we have used that information to prevent shortages.” FDASIA also requires FDA to cite companies that don’t notify the agency about potential shortages. “Other FDASIA requirements involve improving our internal and external communications; improving communication between FDA and the Drug Enforcement Administration regarding shortages of controlled substances; and developing a strategic plan to enhance FDA’s response to preventing and mitigating drug shortages,” says Thakur.
Thakur believes that a reduction in drug shortages in recent years is due to a combination of FDA efforts and notifications from manufacturers and healthcare providers, although there is still work to be done. “The downward trend in shortages, the uptick in notifications, and the increased focus on manufacturing quality are all things we hope will continue,” says Thakur.