It’s the Citizens that the currently unfriendly FDA are there to serve, a fact long forgotten by the current FDA. Also, TIMELY access to innovative new treatments for patients with late stage disease where there are no good alternative treatments available, which was important enough to encompass within the revised FDA mission statement, must be a priority. That mission was not accomplished under our current FDA chief.

The next FDA commissioner needs to remember the mission of the FDA is to protect and serve the Citizens and to speed innovative, safer new treatments to them. The next commissioner should stop ignoring the pleas of the citizens! In the current FDA the Citizens have no voice and nobody at the top levels of the FDA has shown any inclination towards being caring or sensitive to patient rights.

Currently, Citizens do not have a voice in the FDA. The Citizen Petition process at the FDA is broken. The FDA is completely unresponsive to filed Petitions. The FDA’s consideration of the opinions of patient advocates, and even their own hired expert’s opinions at Advisory Committee hearings, are given mere lip service.

The public is given no rights, no voice, and no way to express its concerns to the Agency. There is very little support left for the agency in its current decayed state. Even the staunchest of supporters, such as Peter Barton Hutt, former FDA Counsel, who went before the Energy and Commerce Committee in January 2008 to ask for more funds for the agency, when current commissioner Andrew von Eschenbach would not do so,(as he was afraid to anger/upstage President Bush), now admits that the agency is broken. “This is a fundamentally broken agency,” Hutt stated earlier this year, “and it needs to be repaired.” Mr. Hutt has laid out some basic principles for sound government regulatory policy. They are:

1. To protect the public from harm.
2. To preserve maximum individual freedom of choice.
3. To guarantee meaningful public participation in the decision making process.
4. To promote consistent and dependable rules that are equally applicable to everyone.
5. To provide prompt decisions on all of the issues that arises in a regulatory context.

Quoting Mr. Hutt: “The third principle is an easy one — public participation. Our country was founded on the democratic principle of participation.

During the early years of government regulation this was not a central issue because the government was not regulating very much, its
intrusiveness was not very noticeable, and therefore participation was not sought after. But as regulation has grown and real restrictions have affected all of us, public participation has become essential to legitimizing the regulatory process. In my opinion, the most important
statutes Congress has enacted in the past 100 years are the Freedom of Information Act, the Sunshine Act, and the Advisory Committee Act”.

Currently, the FDA ignores the public to the point that it is seemingly annoyed that the public dare even bother them, has made a mockery of the Advisory Committee Act, is unresponsive to Freedom of Information Act requests and has absolutely no transparency or accountability. Nobody knows how a decision to approve or deny a license is even made.

All of this is easily demonstrated by a review of the case of Provenge. In the case of Provenge, an immunotherapy for late stage prostate cancer patients, the FDA ignored its own expert advisory committee and patient advocates at the AC hearing, refused to decide a Citizen Petition regarding Provenge filed in July 2007, and ignored a Freedom of Information (FOIA) request to the FDA CDER division, to produce documents relative to the matter. The FDA has also ignored the advocates call for approval, despite an October 2008 Independent Data Monitoring Company (IDMC) report showing increased survival and no safety concerns for Provenge.

The next FDA Commissioner needs to be someone who can understand the principles of regulatory government, and he must be someone who knows who he works for. He/she must be one who will strive for a more transparent, accountable and citizen friendly agency.

Note: Provenge once was not approved because it missed on an endpoint of Time to Progression (TTP) by two one thousands of one percent, even though it showed survival, because survival was not the pre designated primary endpoint. Since then, an IDMC said that Provenge again showed a survival advantage, and it is safe, but it showed 20% survival, and not the 22% commanded by the FDA during an interim study peek, and the FDA again would not approve. In a January 2008 letter from FDA CBER division head Jesse Goodman, he indicated that the agency was actively considering our citizen petition to reconsider Provenge approval, yet the agency has been completely unresponsive, despite the additional survival evidence recently reported by the IDMC. In the meantime 30,000 American men die of prostate cancer every year, without the benefit of this non invasive, safe and effective immune boosting treatment, which would help them fight for their lives.

Kerry M. Donahue
6295 Emerald Parkway
Dublin, Ohio 43016

Popularity: 57%

Tags: Andrew Von Eschenbach, Dendreon, FDA, george bush, Jesse Goodman, Kerry Donahue, Prostate Cancer, provenge

This entry was posted on Monday, December 15th, 2008 at 10:44 am and is filed under The Cause, The Dysfunctional FDA. 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.