A Policy Shift: Medication Guides May be Eliminated From REMS in Some Cases

By Carrie S. Martin –

In a draft guidance issued on February 28, 2011, called “Medication Guides – Distribution Requirements and Inclusion in Risk Evaluation and Mitigation Services (REMS),” FDA proposes:  (1) to implement a procedure that allows applicants with a REMS to request eliminating a Medication Guide (“Med Guide”) requirement from the REMS; and (2) to exercise enforcement discretion regarding incorrect distribution of Med Guides to healthcare providers (“HCPs”) and patients.

Eliminating Med Guides from REMS.  FDA’s Med Guide regulations (21 C.F.R. Part 208) were issued in 1998 and require the distribution of Med Guides for certain drugs and biological products that FDA determines pose a serious and significant public health concern.  The Food and Drug Amendments Act of 2007 (“FDAAA”) authorized FDA to require a REMS if the Agency determines that certain measures are necessary to ensure the benefits of a drug with a known or potential risk outweigh its risks.  Under FDAAA, a REMS can include a Med Guide, elements to ensure safe use (“ETASU”), such as limits on distribution, and a communication plan to HCPs.  Despite the two regulatory pathways to a Med Guide, all new Med Guides required by FDA since the enactment of FDAAA, as well as all safety changes to an existing Med Guide, have been part of a REMS.  As a result, the vast majority of the REMS are Med Guide-only REMS that do not include ETASU or communication plans.  Making the Med Guide as part of the REMS subjects the applicant to other requirements implemented by FDAAA that are not included in Part 208, such the creation of an assessment plan.     

With the draft guidance, FDA proposes to allow applicants with Med Guide-only REMS to submit a prior approval supplement (“PAS”) that “proposes a REMS modification to eliminate the REMS if [the applicant does] not believe that the REMS is necessary to ensure that the benefits of the drugs outweigh the risks.”  Similarly, if the REMS includes a Med Guide and a communication plan, the applicant may also submit a PAS to eliminate the Med Guide.  Of note, the draft guidance is silent as to whether an applicant with a REMS that includes a Med Guide and ETASU can similarly request elimination of a Med Guide.  Also of note, if FDA approves the PAS, the Med Guide will endure as labeling and must meet the requirements in Part 208 unless FDA approves a supplement that requests eliminating the Med Guide completely. 

Enforcement Discretion.  The Med Guide regulations in Part 208 are intended to apply primarily in an outpatient setting and require that the Med Guides be distributed directly to a patient via a pharmacist.  However, in many instances, the drug – and hence the Med Guide – is dispensed to an HCP who then gives the drug to the patient.  This often happens in hospital settings, for example.  This had created some confusion over whether the Med Guide needed to be provided to the patient each time the HCP administered the drug.  Under this draft guidance, FDA plans to exercise enforcement discretion when the drug is dispensed to an HCP for administration to a patient in an inpatient setting or an outpatient setting, such as in a clinic or dialysis center, with several exceptions.  FDA will not exercise enforcement discretion (i.e., a Med Guide must be distributed directly to patients) when:  (1) a patient requests a Med Guide; (2) the drug is given in an outpatient setting but will by used by the patient without supervision by an HCP; (3) when a HCP first gives a drug to the patient in an outpatient setting; or (4) when the HCP first dispenses a drug to patient after the Med Guide has been “materially changed.”

Submission of Comments.  FDA requests comments on the draft guidance be submitted by May 31, 2011.  Electronic comments can be submitted via the following website:  http://www.regulations.gov.  Written comments should go to the Division of Dockets Management (HFA-305), FDA, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.