On November 19, 2007, the FDA posted a consumer update entitled “New Steps to Improve Advisory Committee Processes.” The stated goal of these actions is to strengthen its advisory committee process in ways which are consistent with recommendations of the Institute of Medicine.

“One of FDA’s strengths is that we routinely enlist the nation’s leading experts to give us public advice on complex medical and scientific issues,” said Randall Lutter, Ph.D., FDA’s Deputy Commissioner for Policy. “The new steps we’re taking further enhance the transparency and reliability of our advisory committee processes.”

Currently, the approval process the FDA uses to approve drugs and treatments involve convening an Advisory Committee of experts to dialogue with and evaluate the data submitted by the sponsor seeking FDA approval.

The meeting starts with the sponsor giving a formal presentation to the advisory committee. During this presentation, the sponsor offers its evidence in support of the application. During the presentation, members of the advisory committee and representative from the FDA, who are also present, ask questions of the sponsor about the material that it has submitted.

After this part of the meeting has been concluded, the public is given an opportunity to provide testimony. It is at this time that both advocates and detractors can share with the advisory committee their opinions, concerns and stories that relate to the application. This is the time that advocates tell their story and try to put a human face on to the problem that the sponsor is trying remedy.

After the limited time earmarked for public comment, the FDA has an opportunity to present their concerns about the application. Usually, there is then a dialog between the FDA, the committee and the sponsor about the application.

At the completion of the phase, the advisory committee then will vote whether or not to recommend that the FDA approve the application. Usually the vote is split into two parts, is the drug/treatment safe and has the drug/treatment demonstrated its efficacy.

The recommendation/vote of the advisory committee are then submitted to the FDA, which will then make the final decision. The decision of the advisory committee is just a recommendation, however, the FDA usually (but not all the time) follows the committee”s recommendation.

The FDS’s response after the recent Provenge advisory committee hearings have raised a number of concerns from the public. Many people were surprised that the FDA failed to follow its advisory committee’s recommendation and approve Provenge. The committee voted 17 to 0 in confirming that Provenge was safe and voted 13 to 4 that the vaccine demonstrated efficacy. Despite this vote, the FDA declined to approve Provenge and asked the sponsor to do additional testing. In response to this, many advocates for Provenge took to the street to protest the FDA’s decision.

The protests included accusations that some members of the advisory committee had significant economic conflicts and should have been excluded from the committee. The FDA has responded that they are unable to find an adequate number of acceptable experts to serve on their committees who do not also have economic conflicts. The FDA’s new proposed rules (New Steps to Improve Advisory Committee Process-see above) calls for additional disclosure of potential conflicts that the committee members may have as well as public access to information from the FDA when waivers are granted. However, It continues to allow members of the committees who have conflicts to seek waivers.

Another rule change by the FDA calls for new operating procedures to insure security and “proper public conduct” at the advisory committee meetings. The consumer update does not explain what the problems at the hearings have been and what new procedures are going to be put in place to ensure proper public decorum. I am very concerned about this and I am trying to find out where the FDA is intending to go with this issue, I will report what I am able to find out in future posts.

The public comments are already restricted to one short period of the meeting and the seating arrangement at the last meeting I attended isolated the public in a far corner of the hearing room. Those advocates who did testify were restricted to using a podium that was placed on the farthest corner from the committee and did not allow them to make eye contact with the committee members who they were addressing. Many advocates came away from the meeting feeling that they were intentionally isolated from the committee to restrict their effect on the committee members.

One good proposal calls for the simultaneous voting of all the committee members along with the simultaneous disclosure of the vote. I completely support this proposal.

I remain very concerned about additional restrictions on the public at the committee hearings. I want to understand the concerns that the FDA has about security and public behavior and we are entitled to know specifically what changes the FDA is considering.

Joel T Nowak MA, MSW