QDIS Blog

If you are a regular reader you know I’ve posted several times about the antibiotic Ketek (telithromycin). It seems that Senator Charles Grassley (D) Iowa has asked for information from the FDA on this and that the FDA has not responded appropriately.

PharmaLive: Grassley Makes Available Responses from FDA Nominee :

Here are the three aspects that are pertinent .

1. Written answers from von Eschenbach to confirmation hearing questions from Grassley (pdf)
2. Letter from Grassley to the Senate Majority Leader placing a hold on the von Eschenbach nomination
3. Letters from Grassley to the Secretary of Health and Human Services regarding agency responses to congressional inquiries.

The third point is the one I want to more fully discuss.

I fully agree with the need for any agency including the FDA to respond to congressional inquiry. The third letter is interesting in that it states in no uncertain terms that Grassley feels the FDA has not been forthcoming with information and may be withholding information. Here is a portion:

In recent weeks, my Committee staff interviewed a number of FDA officials who
referred to extremely relevant documents, which have been withheld from the Committee
to date. Further, the Committee is aware that at least three FDA officials, who played
integral roles in the FDA’s review of Ketek, were never asked to review their files and
turn over relevant documents in their possession to the Office of Legislation. For
example, most recently, my Committee staff was to interview the Regulatory Project
Manager (RPM) for Ketek, pursuant to my request letter, dated October 5, 2006. Last
Wednesday, more than six months since the Committee subpoenaed Ketek documents,
FDA notified my Committee staff that during interview preparation it was discovered that
the RPM was never directed to produce documents responsive to the Committee’s
subpoenas. It is simply dumbfounding that someone as centrally involved as the RPM in
the review of a drug was not directed to produce documents pursuant to the Committee’s
subpoenas. This latest “oversight” is but one of many that shows the inability of
HHS/FDA to comply with the Committee’s subpoenas in good faith.

While it may not be deliberate, it certainly is disturbing that there my be this sort of lack of communication.

The original subpoenas were issued May 19, 2006 and as of Nov. 21, 2006 the response still had problems according to Grassley especially with regard to redacted information where no notation was made as to why the information was redacted.

I know that Grassley has a reputation of being tough on the FDA and some have come out against this hold. See (Eye on FDA: Hold It). I think that if the FDA indeed has not appropriately replied to the subpoena then it might be justified. I personally don’t think it help the situation in the long run but I do know that congressional oversight has been lacking and that that situation may be changing starting next year now that the Democrats control Congress.

This has also been covered in the following article from the Washington post.

FDA, Lawmaker Clash Over Antibiotic - washingtonpost.com:

What is interesting is this reply to Grassley from Dr. von Eschenbach

Von Eschenbach wrote that “the disclosure of information that might relate to any open investigation in response to congressional inquiries poses an inherent threat to the integrity of the executive branch’s enforcement and litigation functions.”

This sounds like what I’m sure we will here a lot of in the coming year; executive powers.

I personally think there are ways to handle this where the enforcement and litigation can be handled without causing problems and feel this sort of reply from Dr. von Eschbach certainly doe not bode well with regard to working with Congress. If I were up for a position of any sort, this certainly would not be the tone of my rply to an important group I knew I would have to work with closely in the future.

Here was Senator Grasley’s response.

“The actions and words of this nominee display a misunderstanding of congressional oversight of the executive branch of government,” Grassley said.

I think we are going to hear much more of this sort of exchange between the executive branch and the legislative branch for the next two years. I think it could lead to some ugly confrontations and eventually the judicial branch may be involved. It will be interesting to see how this develops.

This appears to me to be setting up a showdown and it looks like it could go on for sometime. In the meantime, consumers lose because again, the FDA has no permanent leadership.

Technorati Tags: drug safety, FDA, Grassley, Ketek, telithromycin

Email Ed Vawter

Bookmark it with: | del.icio.us | Digg it | Furl | Simpy | Spurl | My Yahoo! |