FDA administrators "mishandled the initiative through bureaucratic infighting, flawed planning and duplicative work performed by outside contractors." The report estimates that agency administrators wasted $25 million on a computer system that won't be functional before 2009.
What, in addition to $6,000 does the governor of Texas have to gain by issuing an order REQUIRING all Texas 11 year old girls to be vaccinated?
In essence FDA proposals merely change the seating arrangement on the deck of the sinking Titanic. Eli Lilly announced that it intends to seek FDA approval for a long-lasting injectable form of Zyprexa (taken once a month).
The FDA is salivating in expectation of increased funding from the drug industry–ostensibly to speed up the reviewing process for TV ads.
FDA Commissioner Nominee told Senate He’s Open to Independent Safety Unit / Biogen issues Avonex Warning Fri, 18 Mar 2005 It would be impossible to gain insight into Lester Crawford’s confirmation hearings by the Senate Health, Education, Labor and Pensions committee if one read only one news report. The Los…
To view AHRP news and infomails from 2006, please visit our new site. Infomails Subscribe to AHRP’s infomails At FDA, Graham is still the whistle-blower Loss of Trust: Big Drug Makers See Sales Decline With Their Image War hero’s death in clinical trial follows years of FDA neglect European perspective:…
Guidant Case May Involve Crime Inquiry Thu, 29 Sep 2005 The New York Times reports that “criminal investigators at the Food and Drug Administration have apparently become involved in the agency’s inquiry into how the Guidant Corporation handled problems with its heart devices, said two people contacted by the investigators."…
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 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…
The Crawford Resignation Mystery Sat, 24 Sep 2005 Merrill Goozner of Center for Science in the Public Interest provides insight into what may lie behind the sudden resignation of FDA Commissioner, Lester Crawford. Goozner surggests, “One possible clue to the administration’s thinking comes from the appointment of Andrew von Eschenbach,…
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…
