FDA´s Drug Safety Draft Guidance regarding REMS

On September 20, 2016, the Food and Drug Administration (FDA) published a draft guidance for industry on the "Application of Statutory Factors in Determining When a REMS Is Necessary" for comment. Comments and suggestions should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft.

The FDA says that the guidance is intended to clarify how the FDA applies the factors in determining whether a risk evaluation and mitigation strategy (REMS) is necessary to ensure that the benefits of a drug outweigh its risks. The guidance is one of several being developed to fulfil performance goals that FDA agreed to satisfy in the context of the fifth reauthorization of the prescription drug user fee program (the Prescription Drug User Fee Act (PDUFA). "By providing greater clarity about FDA’s application of these statutory factors, FDA hopes to increase understanding about how and when FDA determines that a REMS is required."

"A REMS is a required risk management strategy that can include one or more elements to ensure that the benefits of a drug outweigh its risks. A REMS may consist of

  • a Medication Guide,
  • a patient package insert,
  • and/or a communication plan.

FDA may also require certain elements to assure safe use (ETASU) as part of a REMS. The ETASU can include, for example, requirements that health care providers who prescribe the drug have particular training or experience, that patients using the drug be monitored, or that the drug be dispensed to patients with evidence or other documentation of safe use conditions. Certain REMS with ETASU may also include an implementation system through which the sponsor is able to monitor and evaluate implementation of the ETASU and work to improve their implementation. Finally, REMS generally must have a timetable for submission of assessments of the strategy. FDA can require a REMS before initial approval of a new drug application or, should FDA become aware of new safety information about a drug and determine that a REMS is necessary to ensure that the benefits of the drug outweigh its risks, after the drug has been approved."

The following six factors are considered in making a decision about whether to require a REMS:

  • The seriousness of any known or potential adverse events that may be related to the drug and the background incidence of such events in the population likely to use the drug,
  • The expected benefit of the drug with respect to the disease or condition,
  • The seriousness of the disease or condition that is to be treated with the drug,
  • Whether the drug is a new molecular entity,
  • The expected or actual duration of treatment with the drug,
  • The estimated size of the population likely to use the drug.

These six factors influence FDA’s decisions with respect to both whether a REMS is required for a particular drug and what type of REMS might be necessary.

The selection of REMS elements and tools may be influenced by the extent to which they have already been used in the clinical trials to evaluate the drug’s safety and efficacy, and by what is known about the effectiveness of the elements and tools more generally. Selection of risk management elements and tools is also informed by any regulatory precedent for addressing similar risks. For example, if a serious risk is common to all members of a drug class, FDA will consider how the Agency has previously managed the risk, including whether there has been a uniform approach to risk management. FDA also encourages sponsors to submit REMS proposals that are compatible with established distribution, procurement, and dispensing systems. Following approval of a REMS, FDA continues to evaluate the impact of the REMS on patient access and the health care delivery system.

For more information please see the draft guidance "FDA´s Application of Statutory Factors in Determining When a REMS Is Necessary".

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