New Gardasil® Indication To Be Reviewed By FDA Advisory Committee Mid-Month

This meeting will be the very high-profile beginnings of Merck's specific target-marketing of Gardasil^® to men who have sex with other men. Many in the MSM (Bloomberg chief among these) have already written that they expect FDA will approve the anal cancer indication, and I agree. While Gardasil is already approved for adminsitration to males, if the person speaking favorably about it is not the patient's treating physician, the rules would literally require that the recommendation be restricted to the benefits of possible prevention of HPV, and no mention of it possibility as a pathway to preventing some types of anal cancer. In short, the FDA's expected approval of this indication would make the option specifically available, should a doctor wish to recommend it to a male patient who is sexually active with other men.

From the notice of meeting, at FDA, then (the background materials will be linked on that page sometime around Novemeber 14, 2010):

. . . .On November 17, 2010, the committee will meet in open session to review and discuss the effectiveness of vaccinating males and females with Gardasil manufactured by Merck & Co. for the prevention of anal dysplasia and anal cancer.

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. . . .

We'll cover any interesting developments at the meeting, or disclosures made in the background materials.