Released by FDA: 5/11/00. Posted by FDA: 5/22/00
Beth Connelly, RN.
Senior Associate Regulatory Affairs
Purdue Pharma L.P.
100 Connecticut Avenue
Norwalk, CT 06850-3590
RE: NDA 20-553
OxyContin (oxycodone
hydrochloride Controlled-Release) tablets
MACMIS ID # 8636
Dear Ms. Connelly:
As part of its routine monitoring and surveillance program, the Division of Drug Marketing, Advertising, and Communications (DDMAC) has identified an advertisement for OxyContin (oxycodone hydrochloride Controlled-Release) tablets, disseminated by Purdue Pharma L.P. (Purdue) that violates the Federal Food, Drug, and Cosmetic Act and its implementing regulations. Specifically, your journal advertisement entitled, “Proven Effective in Arthritis Pain,” in the May 4, 2000 issue of the New England Journal of Medicine promotes OxyContin in a manner that is false or misleading. Our specific objections follow:
Misleading Efficacy Presentation
 | You present the headline, “Proven Effective In Arthritis Pain”
on the first page of the journal ad, followed by the results of a
study conducted in 133 patients with moderate to severe osteoarthritis
on the second page. This presentation suggests that OxyContin
has been studied in all types of arthritis and can be used as
first-line therapy for the treatment of osteoarthritis. However,
this suggestion is unsubstantiated and lacks important information
about the study. Specifically, the approved product labeling
(P1) for OxyContin states, “A double-blind, placebo-controlled,
fixed-dose, parallel group study was conducted in 133 patients with
moderate to severe osteoarthritis pain, who were judged as having
inadequate pain control with pm opioids and maximal non-steroidal
anti-inflammatory therapy” (emphasis added). Therefore,
your journal ad is misleading because it suggests that OxyContin can
be used as first-line therapy for the treatment of arthritis when such
has not been demonstrated by substantial evidence. In addition,
the journal ad is misleading because it does not prominently present
the important contextual information that the inclusion criteria for
the study were patients who were judged as having inadequate pain
control with pm opioids and maximal NSAID therapy. |
| You present the headline, “IN A STUDY OF 133 PATIENTS WITH MODERATE TO SEVERE OSTEOARTHRITIS PAIN*,” followed by bulleted claims about this study. This presentation is followed by the product logo for OxyContin along with various doses of OxyContin that are available. This presentation suggests that any dose of OxyContin can be used for the treatment of moderate to severe osteoarthritis pain. However, the study only demonstrated OxyContin 20mg given twice daily to be significantly more effective than placebo at day 7 and 14. In fact, OxyContin 10mg given twice daily was no better than placebo in reducing pain intensity. Therefore, your suggestion that any dose of OxyContin can be used in the treatment of moderate to severe osteoarthritis pain is unsubstantiated, and consequently, misleading. |
Misleading Safety Presentation
| You present a picture of an elderly person on the first page of the journal ad under the headline, “Proven Effective in Arthritis Pain.” Promotional materials are misleading if they promote a drug in a selected class of patients without presenting risk information especially applicable to that selected class of patients. The Warnings section of the PI states that, “Respiratory depression occurs most frequently in elderly or debilitated patients, usually following large initial doses in non-tolerant patients, or when opioids are given in conjunction with other agents that depress respiration.” This risk is not presented in your journal ad. Therefore, the suggestion that OxyContin can be used in the elderly without prominent disclosure of the above risk information is misleading. |
You should immediately discontinue the use of this journal advertisement and all other promotional materials for OxyContin that contain the same or similar claims or presentations. You should submit a written response to us on or before May 25, 2000, describing your intent and plans to comply with the above. Your letter should include a list of materials discontinued and the date on which these materials were discontinued.
You should direct your response to me by facsimile at (301) 594-6771, or by writing at the Food and Drug Administration, Division of Drug Marketing, Advertising and Communications, HFD- 42, Rm. 17B-20, 5600 Fishers Lane, Rockville, MD 20857. We remind you that only written communications are considered official.
Sincerely,
Spencer Salis, Pharm.D.
Regulatory Review Officer
Division of Drug Marketing,
Advertising and Communications
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