Last Friday’s post included information about the recent appointment of Dr. Frank M. Torti as the Acting Director of the FDA. Dr. Torti has invited public comments about the future direction of the FDA. As a representative of Malecare, I have provided specific feedback to Dr. Torti. The following post includes my comments to him. You should consider taking advantage of this unusual opportunity to help shape the future of the FDA. Feel free to borrow the ideas behind Malecare’s comments or to share your own personal concerns.

Dr. Frank M. Torti,

President Obama clearly supports government transparency. So do the 50,000 members of our national men’s cancer support and advocacy nonprofit, Malecare. We ask you to develop clearly stated transparency practices for the FDA.

A: We ask the FDA disclose the decision-making discussions and rationales when FDA policy is developed that is contrary to its expert advisory panel’s recommendations. The advisory committees meet in the open, but the FDA’s final approval decisions are made behind closed doors. We ask that your new administration open all levels of decision making to public view.

B: The FDA has been aware that there are complaints of conflicts of interest of members on their advisory committees. We ask the FDA evaluate if current conflict of interest policies are adequate to guarantee that the committees work progresses without the undue influence of commercial interests. We understand the need for and accept continued participation of committee members with conflicts of interest, but strongly ask that they not be allowed to vote.

Our request is prompted by the recent decision making process around the application for approval of Provenge (for advanced prostate cancer patients) by the company, Dendreon.
During the last 18 months thousands of late stage prostate cancer survivors feel threatened and confused by the FDA’s actions regarding Provenge.

C: We also ask the FDA to make public comment input into the advisory committee processes more consumer friendly.

Representatives of Malecare have testified at the advisory committees meeting about Provenge and Satraplatin. At the Provenge meeting, consumer testifiers were treated warmly and positively. They spoke to the committee directly from the podium located immediately in front of the committee. At the Satraplatin Advisory Committee meeting, the public was corralled into a small space in the rear of the meeting room and were restricted to only voice comments from the back of the room, out of the view of the committee. We feel that our faces and stories are important for all FDA committees to hear and understand. We ask that all consumers have podium, eye-to-eye, opportunities to speak to the advisory committees.

We at Malecare have worked through our national volunteer movement in the service of all male cancer patients. We see your appointment and the new administration as a welcome and life saving sea change. We stand ready to serve with you, as colleagues and collaborators. Please feel encouraged to use our good services for all of our benefit.

Joel Nowak, MA, MSW
Director, Advanced Disease and Advocacy
Malecare, Inc.