FDA Announces Date for Public Meeting on Class-Wide Opioid REMS

By Carrie S. Martin –      

As we reported previously, FDA decided to institute a class-wide Risk Evaluation and Mitigation Strategy (“REMS”) for 24 different opioid products. 

FDA held a private meeting on March 3, 2009, with the 16 manufacturers of the opioid products to discuss the design and development of the REMS.  Dr. Sharon Hertz, Deputy Division Director for the Division of Anesthesia, Analgesia and Rheumatology Products, explained that FDA’s proposed REMS includes a Medication Guide and elements to assure safe use.  Among the elements to assure safe use are certification requirements for health care providers and those who dispense drug and an implementation system that includes a database of all enrolled health care providers and a system to monitor and evaluate the REMS.

FDA has now announced that it will hold a public meeting on May 27 and 28, 2009, to obtain additional input regarding the development of the opioid REMS.  (We have updated our REMS Tracker to include this information.)  Affected sponsors and other interested parties are invited to present their views on FDA’s proposed REMS, how FDA can structure the REMS to minimize the burden patients and health care practitioners while protecting patients, and how FDA should evaluate the effectiveness of the REMS.  Specifically, FDA is seeking public comment on the following questions, among others:

• What education should be required of prescribers and those who dispense medication so that they are properly educated about the risks of the products and can counsel patients on the appropriate use of their medication?

• What education should be provided to patients and should it include a prescriber-patient agreement?

• What additional elements are necessary to support the safe use of approved opioids?

• How extensive should the REMS restrictions be?

• Should the REMS include controls on those who distribute the products to pharmacies and other health care providers and, if so, what kinds of controls?

• What existing systems already exist that could be used to implement the REMS?

• What obstacles need to be addressed before FDA can develop a single, shared system for innovator and generic drug manufacturers?

• What metrics should FDA use to assess the success of the REMS?

To attend the meeting, FDA requires registration via e-mail to OpioidREMS@fda.hhs.gov by May 15, 2009.  Seating is limited, however, and registration will be based on a first-come, first-served basis.  Interested persons may also submit comments to FDA by June 30, 2009, regardless of attendance.  Electronic comments can be submitted to http://www.regulations.gov.  Written comments should be submitted to the Division of Dockets Management (HFA-305), FDA, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.