FDA Drug Safety
Letters (Letters are in Adobe pdf format)
October 8, 2008 |
Letter to FDA Commissioner von Eschenbach regarding Actavis Totawa, LLC |
Sept. 19, 2008 |
Letter to Secretary Rice regarding the expansion of Ranbaxy Probe to Include PEPFAR Program |
Sept. 2, 2008 |
Letter to Schering-Plough and Merck on Vytorin-Cancer Link
Read the Report on the Simvastatin
and
Ezetimibe in Aortic Stenosis (SEAS) Study » |
August 21, 2008 |
Letter to companies Schering-Plough and Merck & Company regarding the safety of Vytorin and Conflicting Study Data
September 4, 2008 Response » |
July 31, 2008 |
Letter to the head of Wyeth Pharmaceuticals regarding a clinical trial being conducted in Ghana to test whether moxidectin can inhibit the production of the parasite associated with river blindness |
July 22, 2008 |
Letter to FDA Commissioner von Eschenbach in regard to drugs sold in the U.S. by Ranbaxy, Inc.
August 28, 2008 Response » |
June 25, 2008 |
Letters to FDA Commissioner von Eschenbach in regard to adverse events linked to the the ProHeart 6 canine heartworm treatment
Letter requesting documents »
Letter requesting information » |
April 30, 2008 |
Letter to FDA Commissioner von Eschenbach in regard to the recent outbreak of Salmonella associated with cantaloupe from Honduras
August 21, 2008, response »
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April 11, 2008 |
Letter to Schering-Plough Corporation and Merck and Co., Inc. in regard to the Committee's continuing investigation of the ENHANCE trial
April 25, 2008 response »
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March 31, 2008 |
Letter to Johnson & Johnson and Amgen Inc., requesting documents relating to the marketing strategies of a class of drugs known as Erythropoiesis-Stimulating Agents (ESAs)
read the Johnson & Johnson Letter »
read the Amgen Inc., Letter » |
March 28, 2008 |
Letter to FDA Commissioner von Eschenbach requesting personnel files of those FDA employees involved in the failed effort to inspect Chinese facilities that supplied bulk heparin to Baxter Laboratories |
March 19, 2008 |
Letter to FDA Commissioner von Eschenbach requesting documents relating to confusion over which Chinese facility supplied bulk heparin |
March 12, 2008 |
Letter to Scientific Protein Laboratories, LLC CEO Strunce requesting information about the company's involvement in the heparin recall
April 2, 2008 response »
March 31, 2008 response » |
March 6, 2008 |
Letter to FDA Commissioner von Eschenbach in regard to a class of drugs known as Erythropoiesis-Stimulating Agents
April 16, 2008 response » |
March 5, 2008 |
Letter to HHS Secretary Leavitt in regard to the Agency's offer to access records related to Dr. von Eschenbach's testimony before the Committee March 22, 2007 |
Feb. 21, 2008 |
Letter to Baxter International Inc in regard to Baxter International's manufactured blood-thinning drug Heparin
March 4, 2008 response » |
Feb. 21, 2008 |
Letter to HHS Secretary Leavitt in regard to Baxter International's manufactured blood-thinning drug Heparin
May 15, 2008 FDA response »
April 17, 2008 response »
February 25, 2008 response »
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Feb. 21, 2008 |
Letter to FDA Commissioner von Eschenbach in regard to Baxter International's manufactured blood-thinning drug Heparin |
Feb. 15, 2008 |
Letter to GAO Comptroller General Walker requesting information about the Agency's oversight study of the FDA |
Feb. 14, 2008 |
Letter to FDA Commissioner von Eschenbach in regard to a Chinese facility which produces a drug that has been associated with hundreds of adverse events
April 24, 2008 response »
March 5, 2008 response » |
Feb. 14, 2008 |
Letter to Office of Management and Budget Director Nussle in regard to findings by the FDA's Science Board as reported in the January 29, 2008 hearing
April 28, 2008 response »
March 18, 2008 response » |
Feb. 11, 2008 |
Letter to FDA Commissioner von Eschenbach requesting further information regarding the ENHANCE trial
April 10, 2008 response »
March 20, 2008 response »
March 3, 2008 response
» |
Feb. 7, 2008 |
Letter to FDA Commissioner von Eschenbach requesting further information regarding findings by the Science Board |
Jan. 24, 2008 |
Letter to Schering-Plough Corporation and Merck & Co., Inc. in regard to the withholding of clinical data during the ENHANCE trial |
Jan. 24, 2008 |
Letter to American College of Cardiology CEO Lewin in regard to the withholding of clinical data during the ENHANCE trial
February 11, 2008 response » |
Jan. 24, 2008 |
Letter to American Heart Association CEO Wheeler in regard to the withholding of clinical data during the ENHANCE trial |
Jan. 22, 2008 |
Letter to Schering-Plough Corporation and Merck and Co., Inc. in regard to the Committee's ongoing investigation into Vytorin and the ENHANCE trial |
Jan. 22, 2008 |
Letter to Health and Human Services in regard to the Committee's ongoing investigation into Vytorin and the ENHANCE trial
February 11, 2008 response » |
Jan. 22, 2008 |
Letter to FDA Commissioner von Eschenbach in regard to the Committee's ongoing investigation into Vytorin and the ENHANCE trial |
Jan. 16, 2008 |
Letter to GAO Comptroller General Walker requesting more information on a possible third class of "Behind-the-Counter" drugs
January 24, 2008 response » |
Jan. 16, 2008 |
Letter to Schering-Plough Corporation and Merck and Co., Inc. in regard to concerns about misleading stat aments in Direct-to-Consumer advertisements of prescription drugs |
Jan. 16, 2008 |
Letter to FDA Commissioner von Eschenbach in regard to concerns about misleading stat aments in Direct-to-Consumer advertisements of prescription drugs
February 1, 2008 response » |
Jan. 7, 2008 |
Letter to CEO and Chairman of the Board Kindler of Pfizer, Inc., in regard to Dr. Robert Jarvik's endorsement of the drug Lipitor |
Dec. 13, 2007 |
Letter to HHS Secretary Leavitt in regard to the recently signed Memorandum of Agreements between China and the United States |
Dec. 11, 2007 |
Letter to Schering-Plough Corporation and Merck & Co., Inc. in regard to withholding of clinical trial data relating to the medical management of hypercholesterolemia |
Nov. 26, 2007 |
Letter to FDA Commissioner von Eschenbach in regard to a report linking use of the the drug Trasylol with increased risk of renal failure and mortality
March 25, 2008 response »
February 6, 2008 response » |
Oct. 30, 2007 |
Letter to Housing and Urban Development Inspector General in regard to allegations of misconduct at the FDA |
Oct. 12, 2007 |
Letter to FDA Commissioner von Eschenbach in regard to observations from a Committee staff oversight trip to China and India |
Oct. 2, 2007 |
Letter to FDA Commissioner von Eschenbach in regard to imported prescription drugs and concerns about their ingredients |
Oct. 1, 2007 |
Letter to CDC Director Gerberding in regard to the continued indiscriminate use of animal antibiotics
Dec. 7, 2007 response » |
Aug. 20, 2007 |
Letter to FDA Commissioner von Eschenbach in regard to FDA inspections of drug manufacturing plants in China and India |
Aug. 1, 2007 |
Letter to GAO Comptroller General Walker requesting a GAO report on the FDA's ability to assure the safety of the drug supply
Aug. 16, 2007 response » |
July 5, 2007 |
Letter to FDA Commissioner von Eschenbach in regard to the conduct of FDA officials in the Avandia matter
August 23, 2007 response » |
July 2, 2007 |
Letter to FDA Commissioner von Eschenbach announcing an investigation of FDA inspections of foreign manufacturing facilities |
June 15, 2007 |
Letter to HHS Secretary Leavitt regarding concerns about Erythropoiesis-Stimulating Agents (ESAs) when used at higher than recommended doses
June 2, 2008 response »
April 17, 2008 response »
January 10, 2008 response »
September 27, 2007 response » |
March 28, 2007 |
Letter to HHS Secretary Leavitt in regard to the accuracy of FDA Commissioner von Eschenbach's testimony at the Committee's March 22, 2007 hearing
April 11, 2007 response »
June 7, 2007 response » |
March 20, 2007 |
Letter to Amgen Chairman, CEO, and President Sharer in regard to the increased risk of blood clots and tumor growths for patients taking the drugs trade-named Aranap and Epogen
April 18, 2007 response » |
March 20, 2007 |
Letter to Johnson & Johnson Chairman and CEO Weldon in regard to the increased risk of blood clots and tumor growths for patients taking the drug trade-named Procrit
April 18, 2007 response »
August 10, 2007 response »
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March 14, 2007 |
Letter to David Ross in regard to additional questions for the record from the Feb. 13, 2007 Drug Safety hearing |
March 14, 2007 |
Letter to John Powers in regard to additional questions for the record from the Feb. 13, 2007 Drug Safety hearing |
March 14, 2007 |
Twenty organizations and individuals write open letter to Congress in regard to events at the FDA and the implications on the nation's health |
March 9, 2007 |
Letter to Group Pharmaceutical Activities Chairman Rothwell in regard to the circumstances surrounding the FDA's approval of the Sanofi-Aventis antibiotic Ketek
June 1, 2007 response » |
March 9, 2007 |
Senator Grassley writes FDA Commissioner von Eschenbach in regard to an FDA employees testifying before Congress |
March 6, 2007 |
Letter from witness, Ann Marie Cisneros in response to questions posed by Ranking Member Barton regarding additional questions for the record from the Feb. 13, 2007 Drug Safety hearing
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April 25, 2007 |
Letter to GAO Director for Public Health and Military Health Care Issues Crosse in regard to additional questions for the record from the March 22, 2007 Drug Safety hearing
response »
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April 25, 2007 |
Letter to University of Washington Professor Psaty in regard to additional questions for the record from the March 22, 2007 Drug Safety hearing
May 1, 2007 response »
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April 25, 2007 |
Letter to the FDA Commissioner von Eschenbach in regard to additional questions for the record from the March 22, 2007 FDA Drug Safety hearing
May 30, 2007 response »
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April 24, 2007 |
Letter to Wake Forest University Professor Furberg in regard to additional questions for the record from the March 22, 2007 FDA Drug Safety hearing
May 7 , 2007 response »
response »
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April 24, 2007 |
Letter to the Critical Path Institute President and CEO Woosley in regard to additional questions for the record from the March 22, 2007 FDA Drug Safety hearing
response »
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April 18, 2007 |
Letter to Commissioner von Eschenbach in regard to the risks associated with antibiotic-treated animals entering the food supply
June 5, 2007 response » |
Feb. 27, 2007 |
Letter to Copernicus Group Chairman and CEO Hill in regard to circumstances surrounding the FDA's approval of the Sanofi-Aventis antibiotic Ketek |
Feb. 27, 2007 |
Letter to PPD CEO Eshelman in regard to circumstances surrounding the FDA's approval of the Sanofi-Aventis antibiotic Ketek
April 13, 2007 response »
March 30, 2007 response »
March 28, 2007 response »
March 22, 2007 response »
March 15, 2007 response »
March 8, 2007 response » |
Feb. 16, 2007 |
Letter to HHS Secretary Leavitt in regard to the management of drug safety issues specific to the drug Ketek
July 24, 2007 response »
July 19, 2007 response »
May 17, 2007 response »
April 25, 2007 response »
April 4, 2007 response »
March 29, 2007 response »
March 1, 2007 response » |
Jan. 29, 2007 |
Letter to FDA Commissioner von Eschenbach in regard to the adequacy of resources devoted to the Office of Generic Drugs |
News Releases
"Dingell, Stupak Applaud FDA Steps on Food and Drug Safety, Pledge Continued Oversight" -- November 18, 2008
"GAO Report Finds FDA’s Foreign Drug Inspection Program Needs Significant Improvement" -- October 22, 2008
"Dingell, Stupak Again Question Whether FDA Knowingly Allowed Dangerous Drugs to be Sold to U.S. Consumers" -- October 8, 2008
"Committee Expands Ranbaxy Probe to Include PEPFAR Program" -- September 19, 2008
"Dingell, Stupak Respond to FDA’s Ranbaxy Announcement" -- September 16, 2008
"Dingell, Stupak Write Schering-Plough and Merch on Vytorin-Cancer Link" -- September 2, 2008
"Dingell, Stupak Question Drug Makers on Safety of Vytorin and Conflicting Study Data; Recent Study Links Vytorin to Increased Cancer Risk" -- August 21, 2008
"Dingell, Stupak Applaud FDA for ESA Label Change" -- August 5, 2008
"Dingell, Stupak Comment on Latest Developments in FDA Salmonella Investigation" -- July 21, 2008
"Dingell, Stupak to Investigate Ranbaxy Drug Approvals" -- July 22, 2008
"Dingell, Stupak Comment on Results of New Vytorin Study" -- July 22, 2008
"Dingell, Stupak Question Whether FDA Knowingly Allowed Potentially Unsafe & Ineffective Drugs into the U.S. Marketplace" -- July 17, 2008
"Dingell, Stupak Question FDA’s Re-approval of ProHeart6" -- June 25, 2008
"After Review of ENHANCE Trial Documents, Dingell, Stupak Express 'Serious Concerns'" -- April 15, 2008
"Committee Panel to Hold Hearings on Heparin Failures" -- March 19, 2008
"How Much Will it Cost to Adequately Fund FDA’s Core Programs? Energy & Commerce Leaders Release Recommendations of Former Members and Advisors to FDA’s Science Advisory Board" -- February 26, 2008
read the letter to Committee Chairmen »
read the FDA's Science Board Report »
"Continues Investigation into Celebrity Drug Endorsements" -- February 7, 2008
"Dingell Blasts Bush’s Health Care Cuts" -- February 4, 2008
"Dingell, Stupak Comment on FDA Plan for Overseas Inspections" -- January 25, 2008
"Dingell, Stupak Question Merck/Schering-Plough’s Sponsorship of American College of Cardiology and American Heart Association" -- January 24, 2008
"Dingell, Stupak Comment on Decision to Pull Vytorin Ads" -- January 23, 2008
"Dingell, Stupak Raise Concerns, Questions on ENHANCE Trial" -- January 16, 2008
"Dingell, Stupak to Continue ENHANCE Trial Investigation" -- January 14, 2008
"Dingell, Stupak Not Satisfied With FDA Response to Committee Requests; Will Consider Other Options to Fulfill Requests" -- May 24, 2007
"Dingell, Stupak Question FDA & Glaxo for Failing to Warn Diabetics of Dangers of Avandia" -- May 21, 2007
"Dingell, Stupak Call on Amgen, Johnson & Johnson to Suspend Direct-to-Consumer Marketing for Anemia Drugs" -- March 21, 2007
Hearing Materials
Statements
May 8, 2008 |
Chairman Stupak at the hearing entitled "Direct-to-Consumer Advertising: Marketing, Education, or Deception?" |
May 8, 2008 |
Chairman Dingell at the hearing entitled "Direct-to-Consumer Advertising: Marketing, Education, or Deception?" |
April 29, 2008 |
Chairman Dingell at the hearing entitled "The Heparin Disaster: Chinese Counterfeits and American Failures" |
April 29, 2008 |
Chairman Stupak at the hearing entitled "The Heparin Disaster: Chinese Counterfeits and American Failures" |
April 22, 2008 |
Chairman Stupak at the hearing entitled "FDA’s Foreign Drug Inspection Program: Weaknesses Place Americans at Risk" |
April 22, 2008 |
Chairman Dingell at the hearing entitled "FDA’s Foreign Drug Inspection Program: Weaknesses Place Americans at Risk" |
February 12, 2008 |
Chairman Dingell at the hearing entitled "Ketek Clinical Study Fraud: What Did Aventis Know" |
February 12, 2008 |
Chairman Stupak at the hearing entitled "Ketek Clinical Study Fraud: What Did Aventis Know" |
January 29, 2008 |
Chairman Dingell at the hearing entitled "Science and Mission at Risk: FDA’s Self-Assessment" |
January 29, 2008 |
Chairman Stupak at the hearing entitled "Science and Mission at Risk: FDA’s Self-Assessment" |
March 22, 2007 |
Chairman Dingell at the hearing entitled "The Adequacy of the FDA Efforts to Assure the Safety of the Drug Supply Part II" |
March 22, 2007 |
Chairman Stupak at the hearing entitled "The Adequacy of the FDA Efforts to Assure the Safety of the Drug Supply Part II" |
February 13, 2007 |
Chairman Stupak at the hearing entitled "The Adequacy of FDA Efforts to Assure the Safety of the Drug Supply" |
February 13, 2007 |
Chairman Dingell at the hearing entitled "The Adequacy of FDA Efforts to Assure the Safety of the Drug Supply" |
November 1, 2007 |
Chairman Dingell at the hearing entitled "FDA Foreign Drug Inspection Program: A System At Risk" |
November 1, 2007 |
Chairman Stupak at the hearing entitled "FDA Foreign Drug Inspection Program: A System at Risk" |
Other Documents
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