A Short Tutorial on REMS: The FDA Perspective

Gerald J. Dal Pan, MD, MHS


April 27, 2012

Editorial Collaboration

Medscape &

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Hello. I am Dr. Gerald Dal Pan, Acting Director of the US Food and Drug Administration (FDA) Office of Surveillance and Epidemiology in the Center for Drug Evaluation and Research. I am pleased to be here today as part of the FDA's Expert Commentary Series on Medscape to raise awareness about Risk Evaluation and Mitigation Strategies (REMS).

On September 27, 2007, the President signed into law the Food and Drug Administration Amendments Act of 2007, also referred to as FDAAA, which, among other things, authorizes FDA to require REMS for prescription drug and biologic products when it is necessary to ensure that the benefits of a drug outweigh the risks. A REMS may contain 1 or more elements to mitigate risks associated with use of the drug. Each REMS program has 1 or more goals to target the achievement of particular health outcomes or knowledge related to known safety risks. Some examples of REMS goals are:

  • To inform patients about the serious risks associated with drug X;

  • To minimize potential drug-drug and disease-drug interactions; and

  • To prevent the risk of fetal exposures to drug X.

REMS programs involve varying degrees of risk management; more serious risks usually require more restrictive programs.

A REMS may require a drug company to communicate with patients using patient labeling, such as a Medication Guide, or to communicate with healthcare providers, such as through Dear Healthcare Provider letters or by disseminating information to professional societies about any serious risks of the drug or any protocol to assure safe use.

A REMS may require elements to assure safe use for those who prescribe or dispense the drug, or for patients taking the drug. For example, prescribing healthcare providers may need to have particular training or experience or be certified. To be certified, a healthcare provider may be required to attest that he or she:

  • Understands the appropriate patient population who can take the product;

  • Understands the risks and benefits of the product and has read the educational materials;

  • Can diagnose and treat potential adverse reactions associated with the product; or

  • Will counsel patients about the serious risks associated with the product.

A REMS may require pharmacists or others who dispense the drug to be certified. For example, to be certified, a pharmacist may be required to fill prescriptions only from enrolled prescribers or only after checking for specified laboratory values to see if the patient has met criteria for receiving a product. The REMS program may require that the drug be dispensed to patients only in certain healthcare settings, such as in hospitals or infusion centers, or in physicians' offices equipped to treat a known serious reaction to the drug, such as an allergic reaction.

Patients may be required to be monitored or to enroll in a registry. This is all in the interest of keeping patients safe.

FDA recognizes that REMS present new challenges for both pharmacists and prescribers. We have heard from prescribers who are concerned about having to enroll in many different programs, obtain different certifications, and comply with various requirements for prescribing the drug. Some are concerned that these restrictive programs interfere with the practice of medicine and are costly to implement without any reimbursement for the costs incurred.

Patients, too, have expressed their concern both individually and through patient advocacy groups that their access to medication may be affected by prescribers who refuse to participate in a REMS or REMS processes that increase the time from when they receive a prescription to the time that they receive the drug.

That said, it should be emphasized that the more restrictive REMS programs are intended to provide safe access for patients to drugs with known serious risks that would otherwise be unavailable. FDA is addressing the input received from stakeholders about the issues and challenges associated with developing and implementing REMS. FDA is also working to hold 1 or more public meetings by the end of fiscal year 2013 to include stakeholders, such as physicians, pharmacists, nurses, patients, the pharmaceutical industry, other federal partners, and partners from other sectors of the healthcare delivery system to explore strategies to standardize REMS. We are committed to exploring strategies to standardize REMS, with the goal of reducing burden on practitioners, patients, and others in the healthcare setting.

I'd like to commend the healthcare community for the tremendous amount of work that has gone into developing and implementing REMS. We hope you will continue your efforts and support in this area.

In conclusion, through a coordinated effort involving all interested stakeholders, we can work together to minimize risks associated with using medications and reduce preventable harm. We need the assistance of prescribers and pharmacists in this effort, and we encourage you to learn more about REMS programs on our Website and subsequent programs available on Medscape.

FDA is committed to making information available about REMS in a timely manner. Thank you.

Related Resources

Guidance for Industry: Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications

Risk Evaluation and Mitigation Strategies (REMS)

CDER New Drug Review: 2011 Update


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