Advisory Committees

May 3-4, 2016: Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee Meeting Announcement

CenterDateTimeLocation
CDERMay 3, 2016
May 4, 2016
8:00 a.m. to 5:00 p.m.
8:00 a.m. to 5:00 p.m.
FDA White Oak Campus
Bldg. 31 Conference Center
The Great Room (Rm. 1503)
10903 New Hampshire Avenue
Silver Spring, Maryland 20993

Agenda

The Food and Drug Administration Amendments Act of 2007 (Public Law 110-85) requires FDA to bring, at least annually, one or more drugs with Risk Evaluation and Mitigation Strategies (REMS) with Elements to Assure Safe Use (ETASU) before its Drug Safety and Risk Management Advisory Committee (DSaRM). On May 3 and 4, 2016, the committees will discuss results from assessments of the extended-release and long-acting (ER/LA) Opioid Analgesics REMS. The Agency will seek the committees’ comments as to whether this REMS with ETASU assures safe use, is not unduly burdensome to patient access to the drugs, and to the extent practicable, minimizes the burden to the healthcare delivery system.

The ER/LA Opioid Analgesics REMS requires that prescriber training will be made available to healthcare providers who prescribe ER/LA opioid analgesics. Training is considered “REMS-compliant” if: (1) It, for training provided by continuing education providers, is offered by an accredited provider to licensed prescribers, (2) it includes all elements of the FDA Blueprint for Prescriber Education for ER/LA Opioid Analgesics (Blueprint), (3) it includes a knowledge assessment of all the sections of the Blueprint, and (4) it is subject to independent audit to confirm that conditions of the REMS training have been met. The Agency will seek the committees’ input on possible modifications to the ER/LA Opioid Analgesics REMS, including expansion of the scope and content of prescriber training and expansion of the REMS program to include immediate-release opioids.

Comments from the public can be submitted to the docket on a broad evaluation of the ER/LA Opioid Analgesics REMS program and whether the ER/LA opioid analgesics REMS should be modified as well as any proposed modifications. Comments may include but are not limited to: (1) Alternative methodologies for evaluating the overall impact of the program on knowledge and behavior by prescribers and patients, (2) the overall impact of the REMS on the adverse events it is intended to mitigate; (3) whether the FDA Blueprint or other tools (e.g., Medication Guide or Patient Counseling Document) should be revised and/or expanded; (4) the use of the continuing education as a component of the REMS as a mechanism for providing prescriber training; (5) whether to expand the REMS program to include immediate-release opioids; and (6) how additional REMS tools or ETASU (e.g., required prescriber or pharmacist training, required patient agreements), if recommended, may impact the healthcare delivery system and patient access to ER/LA opioid analgesics.

Meeting Materials

FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting. Background material is available at: 2016 Meeting Materials, Drug Safety and Risk Management Advisory Committee

Public Participation Information

Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.

  • FDA has opened a docket for public comment on this meeting. The docket number is FDA-2016-N-0820. The docket will open for public comment on March 14, 2016. The docket will close on June 4, 2016. Interested persons may submit either electronic or written comments regarding this meeting. Submit electronic comments to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments received will be posted without change, including any personal information provided. It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Comments received on or before April 19, 2016, will be provided to the committees before the meeting.
  • Oral presentations from the public will be scheduled between approximately 10:30 a.m. and 12:30 p.m. on May 4, 2016. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before April 11, 2016.

Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by April 12, 2016.

Webcast Information

CDER plans to provide a free of charge, live webcast of the May 3-4, 2016 joint meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee. While CDER is working to make webcasts available to the public for all advisory committee meetings held at the White Oak campus, there are instances where the webcast transmission is not successful; staff will work to re-establish the transmission as soon as possible. Further information regarding the webcast, including the web address for the webcast, will be made available at least 2 days in advance of the meeting at the following website: 2016 Meeting Materials, Drug Safety and Risk Management Advisory Committee

CDER plans to post archived webcasts after the meeting, however, in cases where transmission was not successful, archived webcasts will not be available.

Contact Information

  • Stephanie L. Begansky, PharmD
    Center for Drug Evaluation and Research
    Food and Drug Administration
    10903 New Hampshire Avenue
    WO31-2417
    Silver Spring, MD 20993-0002
    Phone: 301-796-9001
    Fax: 301-847-8533
    E-mail: AADPAC@fda.hhs.gov
  • FDA Advisory Committee Information Line
    1-800-741-8138
    (301-443-0572 in the Washington DC area)- follow the prompts to the desired center or product area
    Please call the Information Line for up-to-date information on this meeting.

A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency’s Web site and call the FDA Advisory Committee Information Line to learn about possible modifications before coming to the meeting.

Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Stephanie Begansky at (301) 796-9001 at least 7 days in advance of the meeting.

Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: Common Questions and Answers about FDA Advisory Committee Meetings

FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at Public Conduct During FDA Advisory Committee Meetings for procedures on public conduct during advisory committee meetings.

Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app.2).

Page Last Updated: 03/14/2016
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