Risk Evaluation and Mitigation Strategy (REMS)

Key facts

Legal basis

FD&C Act Section 505-1, added by FDAAA in 2007

Applies to

Prescription drugs and biologics under NDAs, ANDAs and BLAs

Possible components

Medication Guide, communication plan, ETASU, implementation system

Assessment timetable

At least at 18 months, 3 years and 7 years after approval

Public database

REMS@FDA

What is a REMS?

The Food and Drug Administration Amendments Act of 2007 (FDAAA) gave the Food and Drug Administration (FDA) authority to require a REMS when labeling alone cannot manage a known or potential serious risk. FDA can require one before approval, or after approval if new safety information emerges.

Most approved drugs do not have a REMS. Programs range from a communication plan for prescribers to tightly controlled distribution in which only certified prescribers, pharmacies and patients can take part. FDA can modify a REMS or release the requirement when assessments show it is no longer needed.

A generic version of a drug whose REMS includes Elements to Assure Safe Use generally must join a single shared system with the brand, unless FDA waives that requirement.

How a REMS is structured

A REMS can combine the following components:

The isotretinoin program, iPLEDGE, is a widely known example with Elements to Assure Safe Use: prescribers, pharmacies and patients must enroll, and dispensing is tied to documented pregnancy testing for patients who can become pregnant.

• Medication Guide or Patient Package Insert: FDA-approved information given to patients.
• Communication plan: letters, training or materials directed at health care providers.
• Elements to Assure Safe Use (ETASU): prescriber or pharmacy certification, dispensing only in certain settings, dispensing only with documented safe-use conditions such as lab results, patient monitoring, or patient registry enrollment.
• Implementation system: how the sponsor monitors and enforces the ETASU across the supply chain.
• Timetable for assessments: scheduled reports to FDA on whether the program meets its goals.

Why REMS programs matter

A REMS shapes how a drug reaches patients and competitors:

• Distribution and access: ETASU programs often limit dispensing to certified specialty pharmacies or health care settings, which drives channel strategy and patient access.
• Commercial burden: certification and monitoring add work for prescribers, a factor in uptake forecasts and competitive comparisons.
• Generic and biosimilar entry: brand companies have used REMS distribution limits to withhold the samples that developers need for testing. Section 505-1(f)(8) bars using ETASU to block or delay generic approval, and the CREATES Act of 2019 gave developers a way to sue for samples.
• Safety intelligence: REMS approvals, modifications and releases are public on REMS@FDA and mark changes in how FDA views a risk.