Released by FDA: 7/26/01.  Posted by FDA:  8/6/01

Alan R. Bergstrom
Sr. Manager, Regulatory Support
US Drug Regulatory Affairs & Compliance 
Aventis Pharmaceuticals
SC3-735A
300 Somerset Corporate Blvd. 
Parsippany, NJ 08807-2854

RE:    NDA # 20-449
          Taxotere^R (docetaxel) for Injection 
          MACMIS ID# 10198

Dear Mr. Bergstrom:

This letter notifies Aventis Pharmaceuticals (Aventis) 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, Aventis promoted Taxotere for the unapproved use of first-line treatment of locally advanced or metastatic breast cancer at their commercial exhibit booth at the 37th American Society of Clinical Oncology (ASCO) Annual Meeting held in San Francisco, California in May 2001.   Our specific objections follow:

Promotion of an Unapproved Use

In the commercial exhibit booth, Aventis disseminated a promotional brochure¹ describing the safety or effectiveness of their drug Taxotere for the unapproved use of first-line treatment of locally advanced or metastatic breast cancer.   This brochure was freely available to all attendees at the ASCO Annual Meeting and contained conclusionary statements such as:

"Introducing A[driamycin] T[axotere]- the only taxane combination approved for the first-line treatment of locally advanced or metastatic breast cancer."

"The emerging standard for first-line treatment of locally advanced or metastatic breast cancer."

"AT -- Manageable side effects, which were comparable to AC[yclophosphamide] and did not compromise quality of life."

Taxotere is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy and patients with locally advanced or metastatic non-small cell lung cancer after failure of prior platinum-based chemotherapy.   Aventis has not demonstrated that Taxotere is safe or effective for any other uses at this time.

Requested Action

Aventis should immediately cease the distribution of these and other similar promotional materials for Taxotere that contain the same or similar claims or presentations.   Aventis should submit a written response to DDMAC on or before August 9, 2001, describing its intent and plans to comply with the above.   In its letter to DDMAC, Aventis should include the date on which this and other similarly violative materials were discontinued.

Aventis 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. 1713-20, 5600 Fishers Lane, Rockville, MD 20857.   In all future correspondence regarding this matter, please refer to MACMIS ID # 10198 in addition to the NDA number.   DDMAC reminds Aventis 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 two page promotional brochure titled "From a strong foundation comes a better combination" (GM E 01005 0193)