The poster “emrssf” did a very good job of conveying to everyone here the environment at the oral argument. While it is not entirely accurate or complete (he states at the beginning that he does not take shorthand and so it is not presented as entirely accurate) it is close to accurate and in fact it helps me to recall the chronology of events better than I could without it. While he was taking notes on what was being said I was focused on responding to the Judges questions and anticipating my next argument. So I cannot be entirely accurate or complete either.

I have meant to post sooner but this is a tough one to easily summarize because we have so much invested in the legal process to bring us to this point that I am not sure I am the best person to proclaim or account for the event and therefore am thankful to “emrssf” for his help and was happy to see that he seemingly felt the sincere passion in which I tried to present this case, which comes easily when the argument is made from the AIPC patients perspective. If I left accomplishing nothing else I wanted to be sure that the Court understood that we are not talking completely in a conceptual context, or in a vacuum, but rather we are talking about real people, real patients, men without hope and without viable alternatives. I hope this is what “emrssf” meant by his feeling that I truly have patients interests at heart as it gives me hope that the same was conveyed to the Judges. Not a month goes by where CTL is not contacted by a family of an AIPC patient asking if we can help their loved one get Provenge and their pain and sorrow is deeply felt by all of us.

At the risk of annoying those who would like me to get to the point I will digress. About a month or so ago Mike and Rory sent me a book called The Heritage Guide to the Constitution which is a good review of the Constitution and its history. In there it contains a note on Administrative agencies (p. 229).

“Although public officials have long since accommodated themselves to administrative agencies as a necessary adjunct of contemporary government, the nature and reach of agency powers remains controversial. This is especially true of independent agencies, comprising the so-called “headless fourth branch of government,” which from their very inception have been a constitutional anomaly. In theory, independent agencies are subject to the authority of the constitutional branches in the sense that the President appoints agency leadership (subject to senatorial confirmation), Congress authorizes agency expenditures and conducts legislative oversight, and judicial review ensures agency compliance with statutory and constitutional requirements. But these controls precisely because they are remote, indirect, and incomplete, tend to mock the principle of accountability that informs the separation of powers.

…….cont’d on page 230

The enactment of the APA in 1946 quieted many procedural concerns, but the substantial scope of administrative discretion remains a matter of continuing controversy.

EXECUTIVE

Of course those that have read my prior posts know that I believe there is really no executive over sight (because von Eschenbach is a figurehead and more of a PR, fundraising, political guy, then a person who has any real power or control over the particular actions of its top officials day to day, particularly those that have been there much longer and who exercise more real authority over events such as the Provenge BLA, then he does. As you know it is my opinion that von E lacks a full understanding of what happened with regards to Provenge and since he has not really seriously and sincerely reviewed the matter, he has utterly failed the public and his oversight duties as the executive appointee.

LEGISLATIVE

Congress has been for so long hung up on the fact that the Agency’s wine and dine relationship with big pharmaceutical companies might compromise and be a cause of the agencies approval of the very few drugs that later came back with evidence of some safety or efficacy concerns (partially the fault of the press) that they find it hard to, or feel that oversight of the agency relative to the failure to approve a therapy like Provenge, would detract from their central message that the FDA cow tows to big pharma and approves their drugs to easily. Essentially what I am saying is that they will not exercise oversight with regards to non-approval in fear that they will be seen as inconsistent (and because they don’t think the public will understand the difference between big pharma and some start up drug companies and biotechs). Congress will sacrifice Provenge and the patients in order to try to stay consistent and try to lend credibility to its argument that the FDA is failing to protect patients by approving drugs too readily.

Congressman Dingell stated in a letter to FDA regarding their bonuses:

“This is yet another example of the failure of FDA management to understand that its sole purpose for existence is to protect the American people from unsafe food, drugs and medical devices,” said Rep. John D. Dingell (D-MI), the Chairman of the Committee on Energy and Commerce.

That conveniently leaves out that it is not the sole purpose rather the proper revised mission statement of the FDA includes (thank you Commissioner Kessler):

- to promote and protect the public health by helping safe and effective products reach the market in a timely way

http://www.fda.gov/oc/opacom/fda101/sld001.html

Congressman Dingell and Grassely
“The pair will make efforts to address what they consider mishandlings of events by the FDA, such as ………..with more and more critics concerned that the agency isn’t tough enough when reviewing drug safety profiles, allowing drugs like Chantix and Vytorin to slip through the cracks.”
This philosophy makes the case of Provenge fall on deaf ears because Congress can’t square it up with their pervasive overriding philosophy which plays into the media and thus the public perception that the FDA approves unsafe drugs too recklessly at the behest of big Pharma and they as elected Congressmen are seen as being tough on the FDA, when the truth is they are miserably failing at their oversight duty.

THAT LEAVES THE ONLY REAL CHANCE AT OVERSIGHT TO COME FROM

THE JUDICIARY.

Currently the best hope for judicial oversight of the FDA is CareToLive vs. FDA.

The APA is the main theory of jurisdiction of our action (together with U.S.C. section 1331 federal question and constitutional review) and contains the waiver of sovereign immunity needed to sue the FDA.

One of the three Judges, Judge Zouhary recognized that there is some case law that may support review even if the agency action is not found to be final agency action

Trudeau v. Federal Trade Com’n. 456 F.3d 178, 184, 372 U.S.App.D.C. 335, 341 (C.A.D.C.,2006)

Although the APA does not confer jurisdiction, what its judicial review provisions, 5 U.S.C. §§ 701-06, do provide is a limited cause of action for parties adversely affected by agency action

It was with this backdrop that at oral arguments on July 29th that I made my arguments center around the need for transparency and accountability (meaning in this case judicial review of the Provenge process). The fact is that the FDA has never stated an official reason why they denied approval to the Provenge BLA. We do not know exactly how the decision was made, who made it, how it was made, whether there was a committee, was there a meeting, who attended the meeting or what parameters were the basis of the decision. The closest we came to an FDA explanation for their action was the statement issued by Patricia Harley that said it was made on the basis of the two outspoken AC members (Scher and Hussain) that were recruited by Dr. Pazdur.

Transparency is an argument for the FDA to have to account to the patients for their seemingly capricious action to deny them access to Provenge. As I told the panel “if you are going to deny these desperate patients access to a therapy found to be safe and for which an expert committee found there to be substantial evidence of efficacy, then the FDA should at least have to tell these patients why they felt the need to deny them access despite the safety profile”. I told the Court that the FDA has never accounted for the “why” as in why they denied access to dying patients and that the decision to deny access was so contrary to the public face that was put on the matter that it causes the public to question the legitimacy of this agency of government and causes them to lose faith in the FDA’s ability to do its job honestly and capably. Why did the FDA reach a decision that was seemingly contrary to the evidence before the public.

I argued that the FDA has demonstrated an uncaring attitude to the patients they are sworn to help. That the FDA has not properly responded to the patient’s petition filed with the FDA more than a year ago. That when the FDA does respond to patients and advocates, that they are largely dismissive of their concerns. I indicated that 27,000 men per year die but yet the FDA cannot be bothered to respond to their concerns. The FDA acts as if they are very busy and do not have the time to be caring or responsive to patients.

I told the Judges that an FDA self assessment report indicated that the agency lacks the ability to evaluate innovative new medical technologies, yet in the case of Provenge, despite their proclaimed lack of ability to do this without outside help, that they did not follow the advise of the expert committee when they did convene one, which I stressed WAS HANDPICKED BY THE AGENCY.

(Judge Gilman did later ask FDA counsel why they did not follow their expert advisory committee.)

I noted that the FDA should not be free from transparency and any accountability and that a few individuals at the top of the FDA should not be permitted to exercise the kind of unchecked power reminiscent of a Roman Consul. That to do so was a deprivation of due process.

It was around this time that Judge Batcheldor stated that aren’t we here to talk about the ruling of the lower court and the reasons for that ruling and not policy considerations relative to the operation of FDA.

At that point I had been waiting for the first statement/question by the Court and was surprised one did not come a little earlier. I responded that yes the Judge was correct and then stated that the lower Court was wrong to dismiss the matter due to non-final agency action and that the agency made a decision in this matter that was sufficiently final for review. I stated that the decision was certainly final for CareToLive members Richard Ripp, Stephen Study and John Fish and the other 30,000 men that have since died, as well as final for those that grow sicker every day and thus are less likely to be helped by Provenge.

I stated that the FDA had all the data, empanelled an expert committee, had a hearing and made a decision not to grant a license to Provenge based on all the evidence. I stated that Provenge would not be approved until a new license application was submitted. I tried to focus the court on the fact that there is not an ongoing process relative to that previous License request as it had been denied and so nothing is happening on an ongoing basis until a new license application is submitted by Dendreon.

In addition Judge Gilman was the senior member of the three Judge panel and he was largely in control, asking most of the questions. Judge Gilman seemed to recognize that lack of agency action unreasonably withheld is also a basis for review. Which explains this question.

Judge Gilman to FDA counsel (all quotes not exact). “Why does the FDA take so long to decide these matters, they have been working with Dendreon since when 1996 is it?

Judge Gilman: Why can’t they make decisions quicker and I think the Plaintiff has the concern that they will be left waiting forever or at least for a very long time for the FDA to decide things.

I may have the chronology wrong but I believe this was the point the FDA counsel spoke about how the FDA hoped that they would have the data necessary to approve Provenge in October. I leave you to conjecture whether this is true but I suspect that most at the FDA (maybe all but Dr. Pazdur though at this point the FDA he has been ordered to produce the Pazdur documents by December 9th pursuant to CareToLives’s separate pending FOIA litigation) do in fact hope that there is sufficient data for approval come October in hopes that this will all go away. I find it interesting that it was the FDA that on at least two occasions referenced that interim date that “they hope leads to approval” will be available in October.

This left me with the concern that the Court was being lead to wait until October to issue their decision.

Judge Gilman: in a question to me: if this matter is so important why isn’t Dendreon here? Then I started to explain that the interests of each (patient and Dendreon) are not necessarily the same as patients that are sick and dying now……whereupon I was interrupted when he said well if it is approved sooner doesn’t that mean Dendreon would make more money sooner. I replied: certainly but that Dendreon has other products in its pipeline and as with all companies that hope to have products approved by the FDA now or in the future that they have to keep a working relationship with the FDA and from a long term business perspective that it makes more sense not to be involved in the Court with litigation against the FDA…… to which the Judge responded oh you mean they have to keep playing footsie with the FDA. I responded yes that is exactly right Judge, thank you.

“Agency action” is defined by the APA as “the whole or part of an agency rule, order, license, sanction, relief, or the equivalent or denial thereof, or failure to act.” 5 U.S.C. § 551(13).

As such, this is not a situation where notice-and-comment rule-making is taking place, or where a rule or policy is being held out for consideration but is not yet in effect; instead, Plaintiff’s request has been definitively denied. John Doe, Inc. v. Gonzalez 2006 WL 1805685, 13 (D.D.C.) (D.D.C.,2006)

“A ‘failure to act’ … is simply the omission of an action without formally rejecting a request-for example, the failure … to take some decision by a statutory deadline.” Norton v. Southern Utah Wilderness Alliance, 542 U.S. 55, 63, 124 S.Ct. 2373, 159 L.Ed.2d 137 (2004). Section 706(1) provides relief for a failure to act by directing that “the reviewing court shall … compel agency action unlawfully withheld or unreasonably delayed.”

I won’t try to re discuss all that was presented previously but here are a few points:

The argument was made in the brief that the lower Court was wrong not to review the entire record including the CR letter. That may have lead Judge Zouhary to ask: “why didn’t the lower Court review the CR letter” and then Judge Gilman to ask: “was it proper for the lower court to rely on statements by Dendreon as evidence of what the CR said”.

Judge Gilman also asked: “couldn’t the FDA reconsider”

Judge Gilman also asked the FDA counsel if it was true that a new application for license needs to be submitted by Dendreon. The FDA response that no they could amend their previous application and that the application was pending and that there was an ongoing administrative process which caused my focus to be on those answers in my response time.

These answers provoked me to address those things in my response time. I argued that there is no ongoing process with Dendreon that is any different than the ongoing process with any drug or biotech company that wants to gain approval for its products or is conducting trials…they all have an ongoing process with the FDA all the time. That there was nothing pending with regards to the license application …that there was a May 15, 2007 PDUFA date and that just prior to that due date that the FDA effectively denied the license application despite the verbiage the FDA wants to put on the denial of the application. I stated the PDUFA date has some and gone. I then took issue with the words pending. I said noting is pending, that in fact the only difference in the new application might be that Dendreon does not have to recopy and submit the old data as no matter what action the FDA took they were unlikely to throw that old information out. I told the Judge that there was no data being furnished the FDA on an ongoing basis so nothing is going on as an administrative procedure with regards to that last license request. I told the Judge that there was evidence that the FDA has not even considered which indicates that Provenge works even better then the data that was presented to the FDA under the BLA, such as the Dr. Petralyk study that Provenge followed up by Taxotere shows even increased survival data. I told the Court that such evidence is only before the FDA via the Plaintiffs Citizen Petition and is not something being submitted daily or weekly or monthly by Dendreon. I said that theoretically the FDA has no option to reconsider the old application or to consider rolling new data, that the decision on that has been made and the only way the FDA could reconsider (without being ordered) is by the mechanism afforded the FDA by virtue of Plaintiffs citizen petition.

Judge Gilman said he understood the point that nothing more will happen until data is submitted in October.

I then felt the need and responded that companies often do not hit the mark demanded by the FDA in an interim review because, and that this is especially true with regards to immunotherapies that take time to ramp up, because the power of the study is greater when the final data is in which I told him could be 1 to 1 ½ years away and that even then that once the new license is submitted there is a new 6 month review cycle, assuming it obtains priority review again (when I said “new review cycle” he looked surprised).

I finished with a quick reference to alternative theories of jurisdiction and thanked the Court.

I can’t stress enough that my focus was on getting the Court to see the absolute need for transparency and accountability by the FDA to the patients that are affected by the actions of the FDA. That the uncaring attitude displayed by the FDA towards the patients and their families should not be tolerated.

My impression is that the Judges had taken the time to fully review the briefs and that they were well informed on the issues. There is no mandatory decision time but my experience is to get a decision anytime from about 2 weeks to as long as 4 months. That being said I do believe that the Judges understand what is at stake from a time perspective so if the decision is going to be favorable it would more likely come sooner than later. However, I would also not be shocked if they waited to see how things shake out in October since we are now within 60 days of October.

One Judge will write the opinion of the Court and the others will either concur without further written opinion, or concur with written opinion or will write a dissenting opinion.

If the opinion is split 1-2 or 2-1 then the losing side will likely ask for en banc review from the full court panel of Judges. If it went 3-0 against government they would likely do nothing unless they felt the decision was far over reaching. If it was 3-0 against CareToLive then we would file a writ with the US Supreme Court asking for them to review the matter.

By the way Caseystarman was passing through Dublin on his way to New York yesterday so I met with him at a local steakhouse. It was enjoyable to meet with him and he is a very nice and honorable man. I like him even more after I stuck him with the tab…..thanks caseystarman and be safe on your travels!!

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Tags: oral arguments

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