Tuesday, August 18, 2009

Tell the FDA Your Opinion of Gardasil

No doubt the FDA catches some of the rumblings, questions and side-effect horror stories about Merck’s Gardasil that constantly percolate through the internet and media. But now you’ll have a chance to address the agency directly, when the Vaccines and Related Biological Products Advisory Committee meets to discuss the HPV vaccine.

The Committee will meet on September 9, 2009 in Maryland. On the agenda: a discussion about the effectiveness and safety of GlaxoSmithKline’s Cervarix vaccine against the HPV virus for females, and another about the advisability of recommending the Gardasil vaccine for males.

And here’s where you (maybe) come in: the public is invited to make a written or oral presentation of data, information, or a viewpoint about either issue. Background material will hopefully be available online two business days ahead of the meeting; otherwise it will be available after the meeting. Unfortunately only two half-hour public comment sessions are scheduled, so good luck getting in there, but here are the rules anyway.

"Written submissions may be made to the contact person on or before September 4, 2009
Oral presentations from the public will be scheduled between approximately 11:30 a.m. and 12:00 p.m. and 3:40 p.m. and 4:10 p.m.

Those desiring to make 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 27, 2009. 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 September 3, 2009.

Contact Information

Christine Walsh, R.N.1401 Rockville Pike, HFM-71, Rockville, MD 20852301-827-0314FAX: 301-827-0294e-mail: Christine.Walsh@fda.hhs.gov
FDA Advisory Committee Information Line1-800-741-8138 (301-443-0572 in the Washington, DC, area)code 3014512391. Please call the Information Line for up-to-date information on this meeting. "

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