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Response to FDA Black Box warning on ESAs

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1. Pazdur letter from CDER Oncology Drug Products cites dialysis article
2. August 1, 2008: Amgen issued letter from FDA ordering labeling change in cancer patients
3. July31, 2008: FDA uses new law to order change in ESA labeling for cancer patients
4. July31, 2008: FDA orders Amgen to change ESA labeling
5. June 9, 2008: Wall Street Scrutinizes Medicare Payment Proposal
6. March 7,2008: FDA adds to black box warning
7. November 8, 2007: FDA Safety Warnings on ESAs
8. FDA releases new black box warning for ESAs
9. September 12, 2007: FDA advises against curbing dosing of ESAs in ESRD patients
10. September, 2007: NKF K/DOQI Revised Anemia Guidelines
11. September 11, 2007: Dialysis unit recruits Zo to counter Dem's ESA politics
12. August 2, 2007: AAKP Re-releases 1997 Anemia Survey
13. July 24, 2007: Children's Health and Medicare Protection Act of 2007 (Introduced in House)
14. July 20, 2007: Monitoring of Erythropoietin Stimulating Agents for Beneficiaries with End Stage Renal Disease
15. Proposed 2008 Medicare Fee Schedule
16. June 26, 2007: Amgen submits testimony to House Ways and Means Committee
17. June 26, 2007 GAO Testimony on Bundling before House Ways and Means Committee
18. June 26, 2007: AAKP Testifies at House Ways and Means Committee on Anemia Management Care
19. June 26, 2007: House Ways and Means Hearing on Ensuring Kidney Patients Receive Safe and Appropriate Anemia Management Care
20. May 23, 2007: Amgen receives subpoena over promotional activity
21. May 16, 2007: Class action suit against Amgen alleges violaton of security laws
22. May 14, 2007:CMS issues proposed coverage decision on ESAs in oncology
23. May 10, 2007: FDA Votes 15-2 to carry stronger warning labels - Tops hemoglobin at 12
24. May 9, 2007: NYT reports doctors reaping millions for use of anemia drugs
25. May 2, 2007:AAKP Past President and Kidney Patient Comments to FDA on ESAs
26. May 11, 2007: Plaintiff Attorneys Provide Analysis of Drug Advisory Committee Meeting
27. April 18, 2007: St. Louis Doctor Attacks Colleagues on ESA Use
28. April 18, 2007: JAMA publishes observational data on ESA usage in different types dialysis centers
29. April 22, 2007: Lawyers going after off-label use of ESAs
30. April 17, 2007: NY Times continues to make remarks about Amgen that may be misleading
31. April 16, 2007: Mortality rates higher in cancer patients receiving ESAs
32. April 12, 2007: NKF K/DOQI Guidelines updated to reflect recent trials
33. April 10, 2007: Amgen CFO Resigns
34. April 5, 2007:Kidney Care Partners Response to FDA Black Box Warning
35. March 21, 2007: Should NYT be held to a higher standard of reporting? Read this one
36. March 19, 2007: Boston Globe article
37. March 15, 2007: RPA letter to Steven Galson, Director CDER
38. March 14, 2007: CMS Responds to FDA Black Box Warning on ESAs
39. March 13, 2007:AAKP Responds to FDA Black Box Warning on ESAs
40. March 12, 2007: DaVita Response to FDA Black Box Warning
41. March 12, 2007: Nation's Kidney Doctors Express Concern Over U.S. Food and Drug Administration's Health Advisory on Anemia Drugs
42. March 12, 2007: RPA response
43. March 9, 2007: FDA PRESS RELEASE
44. March 9, 2007: FDA Information for Health Care Professionals on ESAs
45. March 9, 2007: FDA Health Information about ESAs
46. November 16, 2006: Normalization of hemoglobin level in patients with chronic kidney disease and anemia.
47. November 16, 2006: Correction of anemia with epoetin alfa in chronic kidney disease.
48. May, 2006: Current NKF Updated Anemia K/DOQI Guidelines
49. January, 2006 - Quality of Life in ESRD with Anemia Management
50. April, 2005 - Understanding Anemia in Chronic Kidney Disease - Kidney Beginnings, 4,5:2005
51. FDA Drug Details