FDA Official Calls Newsletter Unethical – WP / Senate Considers Safety Reform at FDA – LAT

FDA Official Calls Newsletter Unethical – WP / Senate Considers Safety Reform at FDA – LAT Fri, 4 Mar 2005 The Washington Post reports about yet another instance of a high FDA official who misspoke. Dr. Sandra Kweder, Deputy Director of FDA’s Office of New Drugs, sent a letter, “written…

FDA Critics Slam Plan for Safety Reform – Nature

FDA Critics Slam Plan for Safety Reform – Nature Thu, 17 Feb 2005 This is smoke and mirrors and musical chairs. Vera Sharav Alliance for Human Research Protection, New York http://www.nature.com/news/2005/050214/full/050214-11.html Published online: 17 February 2005; | doi:10.1038/news050214-11 FDA critics slam plan for safety reform Emma Marris Calls grow for…

Lies & Broken Promises – Drug firm Websites Fail to Disclose Test Data

Lies & Broken Promises_Drug firm Websites Fail to Disclose Test Data Sun, 9 Jan 2005 One year after PhRMA’s publicized proclamation of its “commitment to transparency” The Boston Globe reviewed pharmaceutical company websites searching for disclosure of clinical trial data. The Globe found that this voluntary approach failed miserably: “Last…

At FDA, Changes In Name Only–Agency Puts Business interests Above Safety

At FDA, Changes In Name Only–Agency Puts Business interests Above Safety Fri, 30 Sep 2005 The sudden resignation of FDA Commissioner, Lester Crawford, after just two months in office, has prompted a bipartisan Senate investigation and requests both by the Senate committee HELP and by congressman Maurice Hinchey (NY) and…

Grassley Calls for Safety Review /Unsafe Drugs Marketed to Consumers / FDA Lacks Leadership

Grassley Calls for Safety Review /Unsafe Drugs Marketed to Consumers / FDA Lacks Leadership Sun, 19 Dec 2004 “We expect the FDA to not put a drug on the market that’s not safe. And you can’t compromise safety, regardless of how much pressure there is to get more drugs on…

Intimidation, Politics and Drug Industry Cripple U.S. Medicine – FDA Permits Dr. David Graham to publish Vioxx Report

Intimidation, Politics and Drug Industry Cripple U.S. Medicine – FDA Permits Dr. David Graham to publish Vioxx Report Wed, 5 Jan 2005 FDA officials could not maintain their iron grip in an effort to suppress evidence of far reaching lethal effects of Vioxx when their actions were in full public…

Article

Congressional Investigations Senate Finance Committee Investigates FDA Aug 4: Sen. Grassley letter (416 K pdf) to 8 drug companies requests list of all antidepressant tests on children (1/1/1990–7/23/2004) Aug 3: Drug safety Hearings-Sept-Congress/ FDA – Lilly Plans to Disclose Data Jul 15: Senate Letter to FDA re: disclosure of risks…

Sen Grassley Expands Investigation – Why did FDA approve Vioxx for Children???

Sen Grassley Expands Investigation – Why did FDA approve Vioxx for Children??? Mon, 18 Oct 2004 The Financial Times of London and The Washington Post report that the Senate Finance Committee is expanding its probe of the FDA and its cosy relationship with drug manufacturers. The Vioxx debacle is but…