Advisory Committee Meeting: Benefits and risks of long-term bisphosphonate use for the treatment and prevention of osteoporosis

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS. ACTION: Notice.
This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.

Name of Committees: Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee.

General Function of the Committees: To provide advice and recommendations to the Agency on FDA's regulatory issues.

Date and Time: The meeting will be held on September 9, 2011, from 8 a.m. to 4:30 p.m.
Location: The Marriott Inn and Conference Center, University of Maryland University College (UMUC), The Ballroom, 3501 University Boulevard East, Adelphi, MD. The conference center telephone number is: 301 985-7300.
Contact Person: Kalyani Bhatt, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, rm. 2417, Silver Spring, MD 20993- 0002, 301-796-9001, FAX: 301-847-8533, email: ACRHD@fda.hhs.gov, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), and 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 appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting.

Agenda: On September 9, 2011, the committees will discuss the benefits and risks of long-term bisphosphonate use for the treatment and prevention of osteoporosis (thinning and weakening of bones that increases the chance of having a broken bone) in light of the emergence of the safety concerns of osteonecrosis of the jaw (jawbone death) and atypical femur fractures (unusual broken thigh bone) that may be associated with the long-term use of bisphosphonates. Bisphosphonates for the treatment and prevention of osteoporosis include: FOSAMAX (alendronate sodium) tablets and solution and FOSAMAX PLUS D (alendronate sodium/cholecalciferol) tablets, Merck & Co., Inc.; ACTONEL (risedronate sodium) tablets, ATELVIA (risedronate sodium) delayed release tablets, and ACTONEL WITH CALCIUM (Copackaged) (risedronate sodium with calcium carbonate) tablets, Warner Chilcott, LLC; BONIVA (ibandronate sodium) tablets and injection, Roche Therapeutics, Inc.; RECLAST (zoledronic acid) injection, Novartis Pharmaceuticals Corp.; and the generic equivalents for these products, if any. 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 http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm.


Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before August 25, 2011. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. 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 August 17, 2011. 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 August 18, 2011.

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 physical disabilities or special needs. If you require special accommodations due to a disability, please contact Kalyani Bhatt at least 7 days in advance of the meeting.

FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm 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). Dated: June 27, 2011. Jill Hartzler Warner, Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2011-17271 Filed 07/08/2011 at 8:45 am; Publication Date: 07/11/2011]
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