What is the purpose of a Risk Evaluation and Mitigation Strategy (REMS)?
REMS are designed to help reduce the occurrence or severity of a particular serious adverse event. They help support a drug’s safe use as described in the product’s FDA-approved prescribing information. Once FDA determines a REMS is necessary for a drug, pharmaceutical manufacturers must develop, implement, and assess the specific REMS for their drug product. It is important for health care professionals, patients, and all others whom REMS affect to be aware that REMS can provide safe access for patients to certain drugs with serious risks that may otherwise not be approved and available on the market.
What medications can have a REMS?
FDA can require a REMS for prescription drugs and biologics if the agency determines it is necessary to ensure that the benefits of the medication outweigh the risks. FDA can also require a REMS for generic prescription medications, but there are some different requirements for generic medications. REMS do not apply to over-the-counter (OTC) medications.
Without a REMS, these medications would not be approved or would be withdrawn from the market because of known or potential serious risks associated with medication.
- How does FDA determine that a medication needs a REMS?
FDA staff (e.g., clinical reviewers, safety reviewers, etc.) use these considerations:
- whether there is a particular risk or risks associated with the medication that, on balance, outweigh(s) its benefits;
- whether additional interventions beyond FDA-approved labeling are necessary to ensure that the drug’s benefits outweigh its risks.
The potential burden of the REMS requirements are also considered.
For further information, please see FDA’s Application of Statutory Factors in Determining When a REMS is Necessary: Guidance for Industry.
The FDA may also seek information from outside experts who provide advice to the agency through advisory committees, as well as patients and caregivers who are living with the problem the drug is designed to treat.
- How does a REMS mitigate a medication’s risk?
REMS may include interventions that support the safe use of the medication. One example might involve a drug that can cause a severe allergic reaction immediately after administration. A REMS is required to ensure the drug is administered only in a health care facility with personnel trained to manage severe allergic reactions and immediate access to necessary treatments and equipment to managing such events. Another example might be to ensure certain lab testing is completed and the results are checked before a medication prescription is refilled. Other REMS may mitigate risks by educating health care providers about which patients may be at greatest risk of experiencing an adverse event and who therefore should not be prescribed a medication.
- Does FDA develop the individual REMS?
While FDA determines that a REMS is necessary, specifies the requirements and approves the specific programs, the medication’s manufacturer is responsible for developing and implementing the program. Some manufacturers develop these programs themselves while other manufacturers hire vendors or other companies to develop and implement the programs on their behalf.
Whom do I contact for information about a particular REMS?
The REMS@FDA website includes information about the current approved REMS, or you can contact FDA at (855) 543-3784 or (301) 796-3400, or by email at email@example.com. You can also refer to the medication’s REMS website that includes information about the specific programs, and contact information for the manufacturer or the REMS administrator.
- How do we know if the REMS is mitigating risk?
The manufacturer of the specific medication is responsible for developing an assessment plan to determine if the REMS is meeting its risk mitigation goal. At periodic intervals following REMS approval, manufacturers submit a REMS assessment report to FDA that includes analysis, findings and conclusions related to whether the REMS is meeting its goals and what if any, modification may be needed.
FDA reviews the REMS assessment reports, determines if the REMS assessment report is complete, if the REMS is meeting its goals, and if the REMS goals, elements, tools or assessment plan should be modified.
- I have heard that having a REMS means there won’t be a generic for the drug, is this true?
No. The law requires that when a drug has a REMS, any generics for these drugs must also have a REMS. Sometimes, the brand name manufacturer and the generic version’s manufacturer jointly develop and implement a REMS (i.e., a shared system REMS). At other times, the brand name drug and the generic each have different REMS, but both have the same goal(s), the same requirements, and comparable processes in place to meet those goals and requirements.
Are REMS permanent? Will FDA ever sunset a REMS?
FDA may release a REMS or remove certain components of a REMS, if, after review of REMS assessments or other information, we determine that the extra measures in a REMS are no longer necessary to ensure a medication’s benefits outweigh its risks.
Are there any medications with approved REMS, where the drug has been removed from the market either because of new serious safety issues or due to risks that could not be mitigated by REMS?
To date, FDA has not removed a drug with a REMS from the market due to new or serious issues that could not be mitigated by the REMS.
FDA maintains a website listing medications with approved REMS that are currently active and their associated materials, at (REMS@FDA).