US FDA policy shift: Medication Guides may be eliminated from REMS in some cases

In a draft guidance issued on February 28, 2011, called Medication Guides - Distribution Requirements and Inclusion in Risk Evaluation and Mitigation Services (REMS), the US Food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

Eliminating Med Guides from REMS. The FDA’s Med Guide regulations (21 CFR. Part 208) were issued in 1998 and require the distribution of Med Guides for certain drugs and biological products that the FDA determines pose a serious and significant public health concern, explains Carrie Martin on law firm Hyman, Phelps & McNamara’s FDA Law Blog

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 the 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 the FDA since the enactment of the 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 the FDAAA that are not included in Part 208, such the creation of an assessment plan, she says.