Commerce Committee opens Vioxx investigation
Executive Summary
House Energy & Commerce Committee officially opens investigation of Vioxx withdrawal with Nov. 23 letters to FDA and Merck. Committee Chair Joe Barton (R-Texas) and Ranking Member John Dingell (D-Mich.) ask FDA and Merck to submit records and internal communications including those related to safety reviews of Vioxx, the 2002 labeling change, advisory committee discussion of the drug and reviews of the 2000 VIGOR study data. The letter to Merck questions promotions for the drug and requests details on recommendations of the data safety monitoring committees of the VIGOR and APPROVe trials. The Senate Finance Committee held a hearing on Vioxx Nov. 18 (1"The Pink Sheet" Nov. 22, 2004, p. 3)...
You may also be interested in...
“Independent” Drug Safety Office Is Goal Of Senate Vioxx Investigation
The idea of an "independent" drug safety office in FDA merits consideration, Office of New Drugs Acting Director Sandra Kweder, MD, said during the Senate Finance Committee hearing Nov. 18 on Merck's withdrawal of Vioxx
US Q1 Consumer Health Earnings Preview: Label This One Historic And Challenging But Promising
US OTC drug and supplement firms’ reports of results for the first three months of 2024 began on April 19 with P&G. JP Morgan analysts say while “some retailers in the US in particular” are reducing consumer health inventories, for the overall sector they expect “a healthier balance of positive volume and lower pricing contribution.”
Keeping Track: Cancer Approvals From Lumisight Imaging To Adjuvant Alecensa
The US FDA’s approval of Lumicell’s optical imaging agent Lumisight makes a dozen novel approvals in 2024 for the Center for Drug Evaluation and Research.