“…not all U.S. citizens want or need unfettered access to potentially dangerous drugs whose market approvals were expedited under the PDUFA.”

“The only expedited new drug approvals should be reserved for compassionate use by cancer and pre-terminal patients, not expedited approvals for the vast majority of citizens who would like nothing more than to feel secure in knowing that marketed drugs bear a reasonable measure of safety.”

So, do I support expedited new drug approvals for drugs such as provenge for use by cancer patients? Yes, with qualifications. I’d sure hate to see cancer patients injured for causes related more to provenge treatment than to their cancer. Do I care that there are investors who are agitated? Not at all. Corporate profits should not be given preference to drug safety. It’s all about the patients. Oh, by the way, is anyone worried that provenge, once approved, will be illegally off-label marketed as a cancer “preventive” to all men worldwide? There would be an entirely different set of safety concerns as to provenge if used for more than just hormone refractory prostate cancer. I think we have to stop short of proclaiming provenge to be a “cure” [much less a preventive] for prostate cancer.

As for Scher, given his many COI’s, I don’t see how anyone could belief that he acted on behalf of the public’s best interest. How was he vetted? Which is the greater evil? The PDUFA or so-called FDA “advisory” meetings? I’d be interested in knowing whether FDA senior management had COI’s relative to provenge.

Two questions would help me better understand this debate: what was the stated basis for Scher’s “go slow” recommendation for FDA? How were the pivotal studies designed? What controls were used? Can someone provide a link to the biological review by CBER?

I hope the court is going to see through this and force FDA to submit pazdur’s computer to complete review by an IT expert in order to get to the bottom of this. I would have thought DOJ would have wanted to find out since their agency by its name(department of Justice) is to seek justice not to defend criminal activities.

Our government has forsaken all citizens in their quest of their corrupt relationships with big business. You can gut a fish but not cut off the head and the fish will rot very fast. If you cut off the head and not gut the fish, it will stay fresh for some time. Folks we have a lot of bad stuff at the top in our government. Its time for big change.

Bruce E. Holmes,PE
2nd VP, Care to Live

The “…GOVERNMENT of the people, by the people, for the people, shall not perish from the Earth.”

–Abraham Lincoln

Within the last decade, FDA stonewalled several of my FOIA requests. In fact, they sat on at least one of my requests for several years. My requests for 483’s and EIR’s related to clinical research in support of NDAs and sNDAs for products whose market approvals were “expedited” under the PDUFA.

I believe, to this day, that the “stonewalling” by FDA of my FOIA requests was willful, because multiple NDAs were involved, ALL of which were granted “expedited” market approvals under the PDUFA.

For lack of a better analogy, the “hare” (pharma’s NDAs) made it to the finish line (market approval) long before (years actually) before my FOIA requests for information (the “tortoise”) from FDA even made it out of the starting blocks. This was intentional.

I strongly believe that the Prescription Drug User Fee Act (PDUFA) is substantially to blame for encouraging both FDA misconduct and clinical research misconduct (research fraud). The PDUFA deprives citizens of 5th amendment equal protection and 9th Amendment equal treatment under law. It is very much a rigged contest between expedited market approvals for pharma and regulatory sanctions and/or formal legal proceedings for research fraud. This explains why there are waves of dangerous drugs and biologicals in the marketplace, ever since the initial enactment of the PDUFA in 1992.

An excerpt from Davidson v. Vivra Inc., U.S. Supreme Court No. 04-537, filed on September 17, 2004, states at page 23,

“FDA officials acting in their personal capacities and the Prescription Drug User Fee Act, enactments I, II, and III (PDUFA I, II, and III) are essential elements in this drug approval enterprise. Serial corporate bribery by Big Pharma of the FDA (acting in their personal capacities) under color of official right provided by the PDUFA I, II, and III, can be likened to the gasoline which fuels the engine of this thoroughly corrupt [drug approval] enterprise. See Opening Brief [9th Circuit docket #03-17342], Page 24, lines 7-12.”

Jeez…it isn’t even brief.

So we get screwed two ways.
DNDN is denied in 2007 after “Byzantine”
shenanigans. Then we pay up the WAZOO to have the FDA and DOJ deny anything ever happened.

Want to take a guess as to what the taxpayer’s paid to the FDA/DOJ for this denial of wrongdoing??

Makes me sick.

But not as sick as when I think about all the men with advanced Pca that were denied access to ProVenge for more than 2 1/2 years.

THAT burden will “bless” the likes of Scher, Pazdur and others who helped derail PV approval.