inhumane fda

Johnson & Johnson Is the Latest FDA Casualty

THE NEXT FDA COMMISSIONER

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 be 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, as 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 AC 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, refuses to decide a Citizen Petition regarding Provenge filed in July 2007, has ignored a FOIA request to CDER to produce documents relative to the matter and has ignored advocates calls 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, be someone who knows who he works for, and one who will strive for a more transparent, accountable and citizen friendly agency.

Note: Provenge was once 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 survival advantage and was safe but it was only 20% survival and not the 22% commanded by the FDA at an interim study peek. Despite a January 2008 letter from Jesse Goodman indicating that the agency was actively considering the petition to reconsider Provenge approval, the agency has since been unresponsive despite the additional evidence as recently reported by the IDMC.