The Unapproved Drugs Initiative (UDI) is a program launched by the Food and Drug Administration (FDA) in 2006 to remove unapproved drugs from the market and ensure that all drugs meet modern standards of safety, effectiveness, quality, and labeling. Unapproved drugs are those that have not been evaluated by the FDA for safety and effectiveness, but are still marketed and sold in the United States. These drugs may pose serious health risks to consumers, such as adverse reactions, drug interactions, or inaccurate dosing.
The UDI has four main objectives:
- To identify and prioritize unapproved drugs for enforcement action
- To take regulatory action against manufacturers and distributors of unapproved drugs
- To encourage manufacturers of unapproved drugs to seek FDA approval
- To educate health care professionals and consumers about the risks of unapproved drugs
The FDA has taken several steps to implement the UDI, such as issuing guidance documents, warning letters, import alerts, and civil or criminal actions against violators. The FDA has also approved several applications for drugs that were previously unapproved, such as colchicine, hydrocodone, and quinine sulfate.
The UDI has resulted in significant public health benefits, such as reducing medication errors, preventing serious adverse events, improving drug quality and labeling, and increasing consumer confidence in the drug supply. The UDI also supports innovation and competition in the pharmaceutical industry by creating a level playing field for all drug manufacturers.
The FDA continues to work with stakeholders to identify and address unapproved drugs in the market and to encourage voluntary compliance with the law. The FDA also welcomes feedback from the public on how to improve the UDI program and its outcomes. For more information on the UDI, please visit https://www.fda.gov/drugs/drug-safety-and-availability/unapproved-drugs.