Released by FDA: 10/17/00.  Posted by FDA:  10/19/00

Christopher Powala 
Sr. Director, Drug Development & Regulatory Affairs 
Collagenex Pharmaceuticals. Inc. 
301 South State Street 
Newtown. PA 18940

RE:  NDA 50-744 
       Periostat (doxycycline hyclate), 20 mg Capsules 
       MACMIS ID #9427

Dear Mr. Powala,

This letter is in reference to Collagenex Pharmaceuticals, Inc.’s (Collagenex) dissemination of two television broadcast advertisements and a print advertisement for Periostat.  We specifically refer to your direct-to-consumer (DTC) advertisements submitted via FDA Form 2253.  You submitted a 15-second “reminder” and 60-second “full product storyboard for television broadcast advertisements, and a print advertisement.  The Division of Drug Marketing. Advertising, and Communications (DDMAC) has reviewed the promotional materials and has concluded that they are misleading under the Federal Food, Drug. and Cosmetic Act (Act) and its implementing regulations.  Our specific objections follow:

Reminder Advertisement

Reminder advertisements call attention to the name of the drug product, but may not contain written, printed, or graphic matter containing representations or suggestions relating to the drug product. This advertisement states that a dentist prescribed the drug for his patient.  Further, the telephone number (1-877-894-GUMS) includes “GUMS.” Both of these presentations imply that the drug is a dental product for aiding gums. Thus, this is a full product advertisement and must comply with all the requirements related to benefits and risk disclosure. 

Failure to Provide Adequate Risk lnformation

The 60-second “full product” advertisement is misleading because it fails to present important risk information.  The advertisement states that one shouldn't "take Periostat if you are pregnant or nursing or if you’re hypersensitive to tetracyclines.”  Failure to give the reason for why pregnant and nursing women should not take Periostat minimizes the significance of the risk information.  To appropriately understand the risk, women patients should know that this is because their children’s teeth could he permanently discolored.  Further, consumers generally would not understand the technical language of the contraindication regarding hypersensitivity to tetracycline.  Neither “hypersensitivity” nor "tetracycline" are consumer friendly terms.  These same objections apply to your print advertisement.

Requested Actions

In our telephone conference with you on October 16. 2000, we requested that you immediately cease the dissemination of these violative advertisements and all similar promotional materials that contain the same or similar claims or presentations.  In a follow-up telephone call the same day. you agreed to cease the dissemination of the advertisements.

If you have any questions, please contact the undersigned by telephone at (301) 827-2831, facsimile (301) 594-6771, or by written communication at the Division of Drug Marketing, Advertising, and Communications, HFD-42; Room 17B-20; 5600 Fishers Lane: Rockville, MD 20857.  DDMAC reminds Collagenex that only written communications are considered official.

In all future correspondence regarding this matter. please refer to MACMIS # 9427 and NDA 50- 744.

Sincerely,

Warren F. Rumble 
Regulatory Review Officer 
Division of Drug Marketing, 
     Advertising and Communications