FIGHTING FOR THE RIGHTS OF THE MEN WITH PROSTATE CANCER THAT THE FDA, DR. HOWARD SCHER & DR. MAHA HUSSAIN COULD CARE LESS ABOUT.

excerpt:

The FDA, with the help of a slew of in house attorneys, has created a labyrinth of regulations, all designed to avoid oversight and minimize due process. One of the latest creations of the FDA is the Complete Response Letter (“CR”), which is a very important, yet still unseen document in this litigation. In the magical world of the FDA they have created a mechanism that Houdini would be proud of. They turned a functionally final decision, into a self declared non-final decision. The issuance of the CR letter, that essentially is believed to say come back and see us in one, two, three or more years, when, or if, you get more data, is no different in application or in function than an outright denial of the application, yet the FDA forces people to accept their contrived definition, which is that a “Complete Response” letter is not a “final response” or even a decision, and that there is still an ongoing process, as they might still approve the application sometime in the nebulous future. In Provenge’s case, the CR letter operates to the applicant, the dying patients, the patient’s families, and everyone else waiting for the treatment, as a complete denial. A CR letter is just the latest fiction created to avoid oversight.

To gain approval after a CR letter, the applicant must go through the same process as if they were submitting a new application. Following either a denial, or a CR letter, dying cancer patients still can’t have access to the treatment. A CR letter and a denial, result in the same outcome in the real world. Certainly there is an ongoing process, but this is a bit of a farce because there is always an ongoing process between the FDA and every biotech or pharmaceutical company in the country. If the FDA denied Provenge via a not approvable letter, there would still be an ongoing process and if the FDA approved Provenge via an approval letter, there would still be an ongoing process since the FDA can always revoke the license or demand more data any time it wishes.

The label or name the FDA puts on an action is not determinative of the reality of the action. Just because the agency says it is not a final decision does not change the fact, that a non approval by CR, and a denial, are in effect the same thing. Apparently the only thing a CR does differently from a not approvable letter, is to diminish both the applicants and the patients due process rights to contest it. Even if the FDA issued a not approvable letter for Provenge on May 8, 2007 instead of a “complete response letter”, the applicant would not have just taken their ball and gone home. They would still be doing the exact same thing: working with the FDA to try to gain approval for Provenge. The same is true for any company that believes it has a medicine that is safe and effective and has cleared all regulatory hurdles to approval.”

CLICK HERE TO READ THE COMPLETE BRIEF ctlreplybrieffinalkerryweb.pdf

GREAT JOB KERRY!

ON BEHALF OF THE PEOPLE OF AMERICA, WE THANK YOU!!!

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Tags: Andrew Von Eschenbach, Bellinger & Donahue, Dendreon, FDA, Howard Scher, Immunotherapy, Kerry Donahue, maha hussain, Prostate Cancer, provenge

This entry was posted on Thursday, February 28th, 2008 at 10:47 pm and is filed under The Cause, The Lawsuit. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.