Bush administration refuses to provide briefing papers on Ketek.The Bush administration failed to comply with a congressional subpoena subpoena (səpē`nə) [Lat.,=under penalty], in law, an order to a witness to appear before a court. A subpoena ad testificandum [Lat. seeking documents related to Sanofi-Aventis's antibiotic Ketek, Bloomberg news service reported.
An investigative subcommittee of the House Energy and Commerce Committee sought briefing papers used to prepare FDA FDA
Food and Drug Administration
n.pr See Food and Drug Administration.
n.pr the abbreviation for the Food and Drug Administration. Commissioner Andrew von Eschenbach for testimony he gave at a hearing on the drug in March. The administration's response was released by the panel Feb. 12.
The subcommittee last year began investigating whether von Eschenbach gave misleading testimony on Ketek at the hearing. The commissioner and FDA are under scrutiny from lawmakers who say the agency hasn't done enough to ensure the safety of Ketek and other medications. The subcommittee held a hearing Feb. 12 on Ketek, which has been linked to fatal side effects Side effects
Effects of a proposed project on other parts of the firm. .
"The department has serious concerns about providing the kind of materials the committee has subpoenaed," wrote officials of FDA and the Health and Human Services Department The Department of Health and Human Services (HHS) is the cabinet-level department of the Executive Branch of the federal government most involved with the health, safety, and welfare of the U.S. population. in a letter to the committee.
Providing "such highly confidential and deliberative de·lib·er·a·tive
1. Assembled or organized for deliberation or debate: a deliberative legislature.
2. Characterized by or for use in deliberation or debate. materials used to prepare witnesses testifying before Congress risks chilling the open exchange of views that is essential to the effective conduct of agency business," wrote Vincent Ventimiglia Jr. of the health department and Susan Winckler of FDA.
The agency offered to brief the committee on issues concerning von Eschenbach's testimony, and the panel hasn't responded, according to according to
1. As stated or indicated by; on the authority of: according to historians.
2. In keeping with: according to instructions.
3. the letter.
Rep. John Dingell John David Dingell, Jr. (born in Colorado Springs, Colorado, July 8 1926) is a Democratic United States Representative from Michigan and is currently the Dean (longest-serving member) of the House of Representatives, with a tenure longer than the entire current time served of 121 (D-MI), chairman of the Energy and Commerce Committee, said at the hearing that he supports holding HHS HHS Department of Health and Human Services. Secretary Michael Leavitt in contempt for failing to comply with the subpoena.
"What is in those briefing books that he does not want either my Republican colleagues or our side to see?" Dingell said. "Is there evidence of perjury perjury (pûr`jərē), in criminal law, the act of willfully and knowingly stating a falsehood under oath or under affirmation in judicial or administrative proceedings. ? Are there statements embarrassing to the administration?"
FDA prohibited marketing Ketek for sinusitis sinusitis
Inflammation of the sinuses. Acute sinusitis, usually due to infections such as the common cold, causes localized pain and tenderness, nasal obstruction and discharge, and malaise. and bronchitis last year after it was linked to liver damage and death in some patients. The drug remains on the U.S. market for pneumonia.
During the hearing before the investigative subcommittee, lawmakers questioned the accuracy of von Eschenbach's written testimony about Ketek. People with first-hand knowledge of FDA's oversight of Ketek "have also raised questions about whether the commissioner or those who helped prepare his testimony intentionally misled the subcommittee," wrote Dingell and Rep. Bart Stupak (D-MI) in a letter to Leavitt after last year's hearing. Stupak is chairman of the investigative panel.
The letter from the lawmakers included an article quoting David Ross, a former FDA scientist who worked on Ketek, saying von Eschenbach's written testimony contained erroneous comments about the agency's handling of the medication. Ross, who detailed his objections to the testimony to reporters at the hearing, took issue with descriptions of what FDA knew about a falsified clinical trial and what information regulators took into account when approving the drug.
The Feb. 12 hearing focused on whether Aventis, a predecessor company to Sanofi, knew when it submitted data from a Ketek clinical trial to FDA that a researcher's results were falsified.
Aventis failed to supervise properly the researchers in the Ketek trial, FDA said in an October warning letter to Sanofi. The company didn't "adequately investigate" reports that a researcher produced false data and enrolled ineligible patients, the agency said.