Editor's note: several of the links following are to PDF documents.
On June 2, 2008, the United States Court of Appeals for the Sixth Circuit, Cincinnati, Ohio, granted CareToLive oral argument in Appeal No. 07-4465, regarding the Southern District of Ohio Court’s decision (case # 07-729). The case is scheduled to be heard on July 29, 2008, before a three-judge panel. The granting of oral argument is just the next installment of a saga that began on May 8, 2007, with the FDA’s issuance of a Complete Response Letter (“Approvable Letter”) to Dendreon in the matter of its Provenge immunotherapy for end stage prostate cancer.
Soon thereafter, CareToLive filed a Citizen Petition, requesting that the FDA reconsider its failure to approve Provenge. This action was followed by the filing of a complaint against Dr. Andrew von Eschenbach, the FDA Commissioner; Hon. Mike Leavitt, Secretary of the U.S. Department of Health and Human Services; Dr. Richard Pazdur, and FDA employee; and Dr. Howard Scher, a Special Government Employee of the FDA. Among other things, the complaint asked the Court to:
A) Enjoin the FDA from denying the marketing and sale of Provenge to androgen-independent prostate cancer patients.
B) In accordance with established United States Common Law, Plaintiffs seek to enjoin the Defendants from denying immediate access to Provenge and ask that all Defendants collectively and individually be restrained and ordered to cease and desist their interference with Dendreon’s lawful attempts to provide aid to dying patients by marketing and distributing Provenge.
C) A declaration that the FDA’s failure to approve Provenge was due to the failure of the FDA to follow its own regulations combined with the improper actions taken by Dr. Howard Scher, and Dr Richard Pazdur that improperly corrupted the process and influenced the decision not to approve Provenge on May 15th 2007.
See the entire document here.
In the exchanges that followed between the CareToLive counsel, Kerry M. Donahue, Esq., and the Department of Justice [DOJ] lawyers representing the defendants, a repeated point of conflict has been the unwillingness of the FDA to release information requested by CareToLive under the Freedom of Information Act [ACT]. Here is but one example of Mr. Donahue’s response to the FDA FOIA’s office unwillingness to comply with U.S. law, following a recitation of assertions made by CareToLive involving the actions of the defendants in this matter:
Defendants assert that the Plaintiffs have no evidence of the facts asserted but nowhere do they say that the allegations are not the truth. At this point in the proceedings all allegations must be taken as true, therefore the contention of Defendants in that regard is not relevant during this stage of the proceedings. In addition, the Defendants have taken extraordinary steps to deny access to the evidence. Not only has the FDA refused to provide documents to Plaintiffs which were demanded under the Freedom of Information Act but they requested that other witnesses not talk to Plaintiffs and not provide documents to Plaintiffs.
The Plaintiff made two FOIA requests. One to the FDA, for which no documents have yet been provided…and one to the National Institute of Health [NIH] which has been recently responded to. That response and the documents provided are attached hereto as “Exhibit A”. The document appears to be a (v3) “third version” of the Scher “leaked” cancer letter. Accompanying e-mails and the other versions were not provided to Plaintiffs by the author of version three, which author was Alison Martin, a current employee of the National Cancer Institute [NCI] and a former employee of the FDA.
In January 2008, the following complaint was filed by CareToLive in the matter of the FDA’s refusal to comply with the FOIA request.
The [Center for Drug Evaluation and Research] CDER division, as well as the Commissioner’s office has not been forthcoming with easily accessible documents and appear to be stonewalling for reasons that may include the fact that three members of Congress have called for a Congressional hearing of the underlying matter, for which the FOIA request, if properly responded to, might provide evidence helpful to that investigation of the underlying wrongful actions of the FDA.
Even today, the FDA persists in playing “hide and seek” with the documents sought by CareToLive, most of which comprise the relevant papers of Dr. Richard Pazdur.
This certainly isn’t the first time that a Federal agency has attempted to stonewall attempts by the public to obtain information regarding their inner workings and the processes they use in making decisions. But a recent decision by the US Court of Appeals for the District of Columbia Circuit on April 25, 2008 should put the FDA on notice that the courts may not be too happy with Federal agencies that play with the law.
In the case cited above, the agency involved is the Federal Communications Commission [FCC] and the issue pertains to broadband over power lines [BPL]. The technology has been pushed by the FCC for some years as being necessary for those who desire Internet access but who can not access and/or afford service through the telephone lines, DSL, cable, or satellite.
Basically, the technology sends wideband Internet signals over the power line to the subscriber’s computer. One of the major problems encountered when deploying this technology, however, is the fact that power lines carrying broadband signals of the type used for Internet communications radiate signals over a broad portion of the radio frequency spectrum, among them being frequencies used by Radio Amateurs and other users of the high frequency (or so-called “shortwave”) portion of the spectrum. This includes shortwave broadcasters, the international airlines, and even the military.
The American Radio Relay League [ARRL], the largest national Amateur Radio organization in the U.S., petitioned the court to review the FCC's orders adopting rules governing broadband over power line implementations. The crux of the problem lay in the assertion by the ARRL that the FCC had failed to comply with the Administrative Procedure Act [APA] by not fully disclosing for public comment the staff studies on which it relied. Writing for the three-judge panel of Circuit Judges Rogers, Tatel and Kavanaugh, Judge Rogers summarized the Court’s findings as follows:
The Commission failed to satisfy the notice and comment requirements of the Administrative Procedure Act (‘APA’) by redacting studies on which it relied in promulgating the rule and failed to provide a reasoned explanation for its choice of the extrapolation factor for measuring Access BPL emissions. [emphasis added]
That the FCC violated the APA hinges on case law. Said the Court:
It would appear to be a fairly obvious proposition that studies upon which an agency relies in promulgating a rule must be made available during the rulemaking in order to afford interested persons meaningful notice and an opportunity for comment.
Further, the Court added:
Where, as here, an agency’s determination ‘is based upon “a complex mix of controversial and uncommented upon data and calculations,"' there is no APA precedent allowing an agency to cherry-pick a study on which it has chosen to rely in part.
Even more damning was the Court’s conclusion in the matter:
[N]o precedent sanctions such a 'hide and seek' application of the APA's notice and comment requirements.
The case involving the FDA’s refusal to turn over documents requested by CareToLive under FOIA and the matter pertaining to the FCC’s game of hiding data from the public that did not favor its position on BPL address two entirely different issues. However, the case involving the FCC and BPL technology serves to demonstrate that even the Federal government is not immune from feeling the sting of the U.S. Court system when an agency attempts to thwart the intent of the law. In the case of the FDA’s withholding information legally sought under the Freedom of Information Act, the issue is made all the more egregious by the fact that the DOJ has been defending the agency against CareToLive’s challenge of the agency’s stonewalling.
It will be interesting to see what the United States Court of Appeals for the Sixth Circuit thinks about the FDA’s game of hide and seek in CTL’s case.
Disclosure: Author has owned shares of Dendreon since 2006