Is it true or false that the FDA cannot require a manufacturer to implement a REMS?

The statement is false because the Food and Drug Administration (FDA) does have the authority to require a Risk Evaluation and Mitigation Strategy (REMS) from manufacturers under certain circumstances. A REMS is a safety strategy to manage a known or potential serious risk associated with a medication.

The FDA may require a REMS when it believes that such a strategy is necessary to ensure that the benefits of a drug outweigh its risks. This can occur when a drug has significant side effects, and the FDA wants to ensure that healthcare providers and patients are adequately informed about these risks. The REMS may include elements such as a communication plan, restricted distribution, or specific training and certification requirements for prescribers.

Since the FDA can mandate a REMS for certain drugs, the assertion that they cannot require a manufacturer to implement one is inaccurate. This regulatory mechanism is in place to enhance patient safety and ensure that risks are appropriately managed.