Risk Evaluation and Mitigation Strategies (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. Sometimes the instructions on drug labels are not enough to ensure that patients and prescribers use a medicine safely. In these cases, the Food and Drug Administration (FDA) has the power to require a REMS. All medicines come with a certain level of risk. This is why all prescription drugs include information reviewed and approved by the FDA about how the medication works in the body, its uses and when it should not be used, possible side effects, the recommended dosage, and other facts about the appropriate use of the drug.

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. All medicines carry some risk. This is why prescription drug information sheets include warnings and possible side effects. This information is approved by the Food and Drug Administration (FDA) and is updated as new information becomes available. Most prescription drugs are safe enough that this information is all that is needed to use the drug safely. However, some drugs have risks that require added measures to assure safe use. For these medicines, the FDA requires the manufacturer to take safety measures beyond the prescribing information and develop a Risk Evaluation and Mitigation Strategy (REMS). The REMS is a set of specific safeguards to combat the drug’s known risks.

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. REMS perform a unique and necessary function: to provide an avenue for the Food and Drug Administration (FDA) to approve certain drugs and biologicals that would otherwise not be on the market. As a result, millions of Americans with serious diseases and rare disorders are now being treated effectively with medications that carry REMS requirements. Prior to 2007 – the year Congress passed the law that established REMS – the nation had witnessed several situations where widely used drugs were taken off the market. This left many patients with limited alternatives and in some cases, no recourse at all. Thus, Congress acted to give FDA the authority to require REMS, resulting in added protections for the public and the pathway needed for FDA to allow patient access to valuable medicines with known safety risks. Yet, even as REMS have become an integral part of FDA’s arsenal to mitigate the potential risks of valuable medicines, protecting patient safety is sometimes viewed as being in conflict with policies to accelerate generic drug development. However, these two goals are not in conflict. This is because very few medicines require REMS restrictions and FDA procedures are in place to ensure that generic versions of REMS drugs are approved with the same REMS requirements as the branded products.

What is included in a REMS?

Depending on the specific medicine and the severity of the safety risks, FDA can require the manufacturer to take a number of specific actions – from providing educational patient information to implementing safeguards designed to control how the medicine is prescribed, dispensed, and taken by patients. Specific REMS measures FDA may require of the manufacturer are: - Distributing with each prescription a Medication Guide that contains FDA-approved information specifically for patients. The medication guide explains the risks of the REMS drug and how to take it safely - Designing and implementing a detailed Communication Plan that informs prescribers and other health professionals about the drug’s risks and how to counsel patients to use it safely - Strict safety measures called “Elements to Assure Safe Use” required when FDA determines that controls, such as requiring pharmacies and prescribing physicians to be certified, are needed to use the medicine safely

Who is responsible for developing a REMS program?

Although FDA makes the decision to require a REMS, it is the responsibility of the drug manufacturer to develop and implement the REMS. FDA requires that a proposed REMS program contain: - The goals of the REMS program - The detailed components that will be developed to ensure the drug is prescribed, dispensed and used safely and appropriately - The steps the manufacturer will take to evaluate whether the REMS is meetings its goals at various points in time