Letter to The Honorable Michael O. Leavitt Secretary Department of Health and Human Services

Letter to The Honorable Michael O. Leavitt Secretary Department of Health and Human Services

The Honorable Michael O. Leavitt
Secretary
Department of Health and Human Services
200 Independence Avenue, S.W.
Washington, D.C. 20201

Dear Secretary Leavitt:

The United States Senate Committee on Finance (Committee) has jurisdiction over the Medicare and Medicaid programs and, accordingly, a responsibility to the more than 80 million Americans who receive health care coverage, including prescription
drugs, under those programs.

The Food and Drug Administration (FDA), Department of Health and Human Services (Department/HHS) has repeatedly delayed the oversight work of this Committee. Last week, I wrote you and Attorney General Gonzales regarding the failure
of the Food and Drug Administration (FDA), Department of Health and Human Services (Department/HHS) to take a number of good faith steps toward fully complying with the Committee's subpoenas to compel the production of information and documents related to the approval and postmarket surveillance of telithromycin (Ketek). Selectively providing documents and access to executive agency officials pursuant to a Congressional subpoena cannot constitute compliance, no matter how voluminous the documents or how many executive agency officials are made available, when relevant documents and information have been "overlooked" or purposefully withheld. Over the past several months my Committee staff have sought and received assurance from FDA's Office of Legislation, both written and verbal, that all relevant FDA officials who worked on Ketek matters were notified to produce documents responsive to the Committee's subpoenas. As long ago as June 5, 2006, Mr. David Boyer, FDA Assistant Commissioner for Legislation, sent an email to my Committee staff, and copied to Mr. Vincent Ventimiglia, HHS Assistant Secretary for Legislation, which stated that "on May 23, an email requesting Ketek-related documents was sent to the heads of appropriate CDER offices, with clear and direct instructions that it be shared
with their employees. Additionally, the email explicitly mentioned emails as documents to be included in all searches/productions/deliveries." The assurances that FDA/HHS provided the Committee have proven to be less than accurate.

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.

Accordingly, as Chairman of the Committee, I respectfully request that HHS/FDA provide the Committee with a list of all HHS/FDA officials who were involved with the review and post-market surveillance of Ketek, as of May 19, 2006. Second, provide the Committee with a list of all HHS/FDA officials who produced documents responsive to the Committee's subpoenas. Please provide this and additional information in a table according to the following format:

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As Chairman of the Committee, I respectfully request your response by no later than December 13, 2006. Before any conversation we have to discuss the pending nomination of Dr. von Eschenbach, it would be most helpful if you personally intervened in this and other matters of importance to the Committee. I refer you to my letters addressed to you, Senator Frist, and Attorney General Gonzales, dated November 15, 16, and 21, 2006, which are attached for your convenience.

If you anticipate any difficulty in complying with this request, please immediately contact my Committee staff. Any questions or concerns should be directed to Dan Donovan, Senior Investigative Counsel, at (202) 224-4515, or dan_donovan@financerep.
senate.gov. All formal correspondence should be sent electronically in PDF format to thomas_novelli@finance-rep.senate.gov or delivered in PDF format on compact disc(s) to the Committee's main office.

cc: Dr. Andrew von Eschenbach
Acting Commissioner
Food and Drug Administration

Sincerely,

Charles E. Grassley
Chairman

http://finance.senate.gov/sitepages/grassley.htm