What Are REMS?
Most Americans have never heard of “Risk Evaluation and Mitigation Strategies” (REMS); yet these drug safety protections give millions of Americans with serious diseases such as cancer and multiple sclerosis access to medicines that would otherwise be too dangerous to be allowed on the market. All medicines carry some risk. But sometimes the standard information included with a prescription medication is not enough to ensure safe use of the drug. In these cases, FDA can require a REMS – additional tools to make sure the benefits of the medicine outweigh its risks. + Read more
How Do REMS Work?
REMS are tools, beyond the standard information that accompanies all prescription medicines, to ensure that a drug is used safely. FDA requires manufacturers to develop REMS with specific safeguards based on the drug’s known risks. These safeguards can include special training for doctors, educational materials for patients, and even certain restrictions on how doctors prescribe and patients get the drug. + Read more
Why Do REMS Matter?
REMS allow patients to access drugs that otherwise would not be available. For these drugs, without REMS, FDA would have no option other than to refuse approval in the first place, or to take the drug off the market if new risks are discovered. The requirements for a REMS can be increased or decreased, as the data support. This is a modern, adaptive regulatory tool that creates a pathway to market for needed medicines that would otherwise be inaccessible to patients. + Read more