April 21, 2000

John W. Jackson CEO 
Celgene Corporation 
7 Powder Horn Drive 
Warren NJ 07059

Re:    NDA 20-785 
         Thalomid (thalidomide) Capsules 
         MACMIS 8909

Dear Mr. Jackson:

This Warning Letter concerns Celgene Corporation’s ("Celgene’s") promotional activities for the marketing of Thalomid (thalidomide) Capsules.  The activities were reviewed by the Division of Drug Marketing, Advertising, and Communications ("DDMAC") as part of its monitoring and surveillance program. We have concluded that Celgene has promoted Thalomid (thalidomide) Capsules for unapproved uses in violation of the Federal Food, Drug, and Cosmetic Act (the "Act") and applicable regulations.  See 21 U. S. C. §§ 331 (a),(b),(d), 352(f),(n), 355(a).

Celgene’s actions are particularly troublesome because the July 16, 1998, approval letter for Thalomid specifically notified you that "statements or implications by you that this product may indeed be safe and efficacious in the treatment of diseases or patient populations beyond that approved in your application may be considered a violation of the promotional provisions of the Act."   Moreover, the Food and Drug Administration ("FDA") has previously advised Celgene that its promotional activities relating to thalidomide violate the Act.  Nonetheless, it is evident that Celgene’s violative conduct is continuing.  More recently, another Celgene sales representative in the northeastern United States promoted the use of thalidomide in cancer patients to an oncologist by stating that thalidomide is "good for weight loss," that it could be used "as an appetite stimulant," and that it is a "great drug for feelings of general well-being."  When the oncologist asked the sales representative if thalidomide had FDA approval for these indications, the sales representative stated, "no, but do you want some material anyway?" This sales presentation was delivered during a luncheon provided by Celgene for an oncology practice group.