Released by FDA: 7/20/01.  Posted by FDA:  7/30/01

Karen Horgan-Peltier, BSN, ET 
Director, Promotional Compliance 
Bristol-Myers Squibb
777 Scudders Mill Road 
Mailbox P-1125 
Plainsboro, NJ 08536

RE:   NDA # [confidential, deleted by FDA]
         UFT (uracil and tegafur) capsules 
         MACMIS # 10137

Dear Ms. Horgan-Peltier:

This letter notifies Bristol-Myers Squibb (BMS) that the Division of Drug Marketing, Advertising, and Communications (DDMAC) has identified promotional activities that are in violation of the Federal Food, Drug, and Cosmetic Act (Act) and its implementing regulations.  Specifically, BMS was promoting its investigational new drug, UFT (uracil and tegafur) capsules as safe or effective at their commercial exhibit booth at the 37^th American Society of Clinical Oncology (ASCO) Annual Meeting held in San Francisco, California in May 2001.  Our specific objections follow:

Promotion of an Investigational Drug

In the commercial exhibit booth, BMS disseminated a promotional brochure¹ describing the safety or effectiveness of their investigational drug UFT capsules.  The claims "Preference," "Tolerability," and "Efficacy" were prominently displayed on the cover of this promotional brochure that contained conclusionary statements such as:

"4 out of 5 patients preferred oral UFT/LV over IV 5-FU/LV having experienced both treatment forms"

"The combination of oral UFT/LV offers an acceptable alternative to bolus IV 5FU, with improved tolerability and patient/prescriber convenience"

"The results of these two pivotal studies show that UFT/LV is equal to 5-FU/LV (Mayo regimen) in terms of overall survival and other study endpoints"

"With comparable efficacy, the improved safety profile of oral UFT/LV indicates that this treatment regimen has a better therapeutic index"

Section 21 CFR 312.7 states, among other things, that an investigational new drug may not be promoted as being safe or effective for uses under investigation.  Therefore, the above claims are in violation of the Act.

In addition, it is particularly concerning that BMS promoted this investigational drug as safe or effective in light of the fact that they received a "not approvable" letter from the U.S. Food and Drug Administration (FDA) in March of this year.

Requested Action

BMS should immediately cease the distribution of these and other similar promotional materials for the above drugs that contain the same or similar claims or presentations. BMS should submit a written response to DDMAC on or before August 3, 2001, describing its intent and plans to comply with the above.  In its letter to DDMAC, BMS should include the date on which this and other similarly violative materials were discontinued.

BMS should direct its response to me by facsimile at (301) 594-6771 or by written communication at the Division of Drug Marketing, Advertising, and Communications, HFD-42,  Rm.17B-20, 5600 Fishers Lane, Rockville, MD 20857.   In all future correspondence regarding this matter, please refer to MACMIS ID # 10137 in addition to the NDA number.   DDMAC reminds BMS that only written communications are considered official.

Sincerely,

 

Joseph A. Grillo, Pharm.D. 
Regulatory Review Officer 
Division of Drug Marketing, 
Advertising, and Communications

___________________________________

¹ A forty-four page promotional brochure titled "Product Overview UFT tegafur-uracil capsules"