| (back) |
|
Mark McClellan, M.D.
Commissioner, Food and Drug Administration U.S. Department of Health and Human Services 200 C. St., SW Washington, D.C. 20204 Mr.
Donald Dobbs, Consumer Safety Officer Dear Dr. McClellan and Mr. Dobbs: I received a letter today from Donald Dobbs in reply to my letters to Dr. McClellan dated January 19 and January 22. I would think that after almost two months to reply to my letters, I would have had my issues of OxyContin addressed. I will reply to this four page letter very briefly as follows: Page 1 – no we are not coping well with the death of Jill and I will tell you why Mr. Dobbs. I will once again ask you and the FDA why you have allowed Purdue Pharma to market OxyContin as a safe, non-addictive drug. Also, in your third paragraph, last sentence you state ….”such as a rare event not previously anticipated from pre- approval testing. You are all quite aware that there is not a rare event with OxyContin having an adverse event. You are very aware that this drug is devastating this country and for whatever reason, you have allowed Purdue Pharma to continue mass marketing OxyContin. Page 3 – “Please also be assured that the FDA shares your concern about the potential abuse and misuse of OxyContin.” I think I have made myself clear that the word is Addictive not the potential abuse and misuse of OxyContin that I questioned you about. You avoid answering me – how can a Schedule II narcotic be marketed and approved by the FDA as safe and nonaddictive? I will continue my efforts to hold not only Purdue Pharma, but the FDA accountable for the travesty you have perpetuated on this country by allowing OxyContin to be mass marketed as non-addictive. Instead of wasting my time by filling out petition forms to the FDA, I will be “petitioning” the Attorney Generals of our country and the U.S. Senate to end this epidemic of OxyContin which you have allowed Purdue Pharma to continue resulting in hundreds if not thousands of deaths throughout our country and countless addicted individuals. You also enclosed a copy of a letter to a Beth Connelly of Purdue Pharma which is undated. I don’t know why you thought this could possibly help me – dates on letters are critical information. I will save you the trouble of taking almost two months to reply to this letter, but will ask the Attorney Generals and the U.S, Senate to prevent other mothers from having to “cope” with the death of a child when the FDA allows a pharmaceutical company to mass market a Schedule II narcotic as non-addictive. I am calling upon the U.S. Senate to reopen their hearings in 2003 on OxyContin and in doing so question the FDA as to their reluctance to require Purdue Pharma to admit OxyContin is highly addictive. Very truly yours, Marianne Skolek |
| (back) |