FDA Drug Safety

(Letters are in Adobe pdf format)

Letters

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
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.
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 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 »
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 »
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 »
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
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 »
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 »
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 »
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 »
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 »
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 Comment on Latest Developments in FDA Salmonella Investigation" -- July 21, 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

May 8, 2008	Direct-to-Consumer Advertising: Marketing, Education, or Deception? (Witness List & Testimony)
April 29, 2008	The Heparin Disaster: Chinese Counterfeits and American Failures (Witness List & Testimony) Powerpoint slides »
February 12, 2008	Ketek Clinical Study Fraud: What Did Aventis Know? (Witness List & Testimony) Exhibit Binder »
January 29, 2008	Science and Mission at Risk: FDA’s Self-Assessment (Witness List & Testimony)
November 1, 2007	FDA Foreign Drug Inspection Program: A System at Risk (Witness List & Testimony)
March 22, 2007	The Adequacy of FDA to Assure the Safety of the Drug Supply - Part II (Witness List & Testimony) Pediatric Exclusivity Labeling Changes »
February 13, 2007	The Adequacy of FDA Efforts to Assure the Safety of the Drug Supply (Witness List & Testimony)

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"