FDA's CBER Gone Fishing While Men Gone Wishing
Now that the holidays are over and can no longer be used as an excuse for inaction, the FDA’s Center for Biologics Evaluation and Research (CBER) has hung the “Gone Fishing” sign on the door. Cold hearted, senseless bureaucracy remains rampant at the Agency, led by the hard to locate new “leadership”.
Even with the endorsement of the best experts the FDA could find, rather than approve the treatment, the FDA issued a Complete Response letter to Dendreon in May of 2007, requesting more data regarding the effectiveness of the treatment. In the face of this needless delay, that was based more on politics then it was on science, Dendreon did as requested and completed an additional large, double blind placebo controlled trial called IMPACT.
In the summer of 2008, prior to final completion of the IMPACT trial, an Independent Data Monitoring Committee (IDMC), monitoring Dendreon’s trial for safety and efficacy, reported that the trial was behaving consistently with previous trials, meaning that there was additional evidence of the safety and effectiveness of Provenge. In other words, this IDMC also told the FDA that Provenge works.
Regardless of the fact that Provenge is no ordinary treatment because it is destined for a late stage cancer population that is without any good treatment options, the FDA again said “no” to immediate approval, for undisclosed reasons.
The group CareToLive, had formally asked the FDA to reconsider their 2007 decision to delay approval of Provenge. Almost two years later the FDA denied that request, even though at the time of the denial it had the additional data from the IDMC in hand, and according to FDA counsel “the approval process was ongoing”.
In April 2009 Dendreon announced completion of the IMPACT trial, and that they had met all protocol assessment requirements as previously demanded by the FDA. That data was presented at the April 2009 American Urological Association meeting in Chicago. Dendreon now clearly had the additional data that was requested by the FDA. This additional clinical data was submitted to the FDA this past summer.
So Provenge is approved right?
The FDA is still reviewing the data.
Why do the late stage prostate cancer patients continue to wait for this groundbreaking new treatment? CareToLive asked CBER that very question in a formal letter that can be seen here: http://caretolive.com/2009-11-23/caretolive-sends-letter-olive-branch-to-cber-requesting-meeting/.
CareToLive suggested that CBER could actually deliver on their promise, a promise previously made to the group in the CBER response to their legally filed citizen petition. That promise was that they would act “expeditiously” upon receiving the additional data on Provenge. The suggestion was made by CareToLive that considering the importance and the critical stage of the patients awaiting the treatment, that perhaps the FDA could complete its review of the pending Provenge application by Christmas 2009.
The director of the CBER division of the FDA not only can’t act expeditiously to review the Provenge application on behalf of late stage cancer patients as they promised, but neither can CBER be bothered to respond to a letter written to them from hopeful and concerned advocates.