Risk Evaluation and Mitigation Strategies (REMS)

Understanding REMS

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.

What are ETASU?

Elements to Assure Safe Use (“ETASU”) are intended to provide patients with safe access to FDA-approved medications that have known serious risks and would otherwise be unavailable. Required ETASU are put in place to mitigate a specific serious risk listed in the labeling of a drug. Read more.

Facts and Figures of REMS

The FDA seriously assesses the risks involved with any approved medication in order to appropriately apply a REMS program. Read more about that process here.

REMS programs have been around for over 10 years and a large amount of numerical data has been collected. Find the updated numbers for REMS programs here.

A number of misconceptions surround REMS programs and the role they play in preserving patient access to medications. Find a list of the most common myths here.

REMS Timeline

Legislation regarding REMS first came about in 2007, however the concern over the risks of prescription drugs dates back to the 1970s. Find an extended timeline here.

REMS History

The creation of REMS not only marked a significant moment for patient safety, it also started making a difference for health providers and the health care system. Read more.

REMS Glossary

Find a glossary of REMS-related terms here.