What is a valid reason for the FDA to withdraw a drug from the market?

The FDA has the authority to withdraw a drug from the market mainly due to negative safety reports from authorities. This can occur when new evidence emerges that indicates a drug poses a significant risk to patients, outweighing its benefits. Such reports can stem from clinical studies, adverse event reports, or safety surveillance data that continually monitor the drug's performance in the real world. When these findings reveal serious concerns about safety—such as harmful side effects or increased mortality rates—the FDA may decide that the drug should no longer be available to protect public health.

In contrast, simply having a lack of sales does not typically justify the withdrawal of a drug, as this does not inherently reflect on the drug’s safety or efficacy. Disputes over chemical composition may indicate quality control issues or manufacturing concerns, which could lead to investigation but may not directly result in market withdrawal unless safety is compromised. Consumer complaints, while important, do not automatically lead to drug withdrawal unless they are substantiated by legitimate safety concerns and are verified through further investigation by health authorities.