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U.S. Department of Health and Human Services


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FDA Responses to Additional Industry Questions on Opioid REMS Submitted Following the May 16, 2011 Meeting


1.  Does FDA have a target date for providing IWG with the Medication Guide Template?  This information is critical for continued preparation of Medication Guide documents for the REMS and REMS Supporting Document submission. 

We continue to work on the Medication Guide Template and expect to be able to provide it by June 24, 2011.

2.  Numerous times IWG has heard that "grant" money was going to be made available for training. Is this "grant" money in reference to the earmark $4,000,000 to be appropriated under the bill (Ryan Creedon Act of 2011) introduced by Representative Bono Mack? Or are there other "grant" money being made available?  Is it the FDA's intention to have CME providers use the grant money to help pay for the development of the educational programs?

FDA expects the sponsors of long-acting and extended release opioids to provide unrestricted grants to CE providers to help pay for the development and execution of the educational programs under the REMS. We understand that this is the mechanism by which pharmaceutical companies now fund other CE educational efforts. If legislation is enacted that would require training as a precondition of DEA registration, FDA expects to revisit the REMS program and make appropriate modifications depending on what the legislation says.

3.  After the REMS is approved, how will FDA communicate what will be required to companies with pending applications?

FDA encourages companies with pending applications to keep informed about the development of the REMS by working with the IWG or following the public information FDA will continue to post on the WEB. Once the REMS is approved, FDA will issue letters to companies with pending applications notifying them of its approval.Once the REMS is approved, FDA will only approve new applications with the approved REMS, and will expect sponsors to implement the REMS through the single shared system before marketing their product. This will mean that sponsors will be expected to contribute to funding the prescriber and patient education and distribute the Medication Guide for their product to pharmacies.