Released by FDA: 3/15/00.  Posted by FDA:  3/27/00

Una Ortell, MSc. 
Regulatory Products Manager 
TAP Holdings Inc. 
Bannockburn Lake Office Plaza 
2355 Waukegan Rd. 
Deerfield, IL 60015

RE:    Prevacid (lansoprazole) Delayed Release Capsules 
         NDA 20-406 
         MACMIS # 8796

Dear Ms. Ortell,

This letter informs you that the 60-second direct-to-consumer (DTC) broadcast advertisement for Prevacid (lansoprazole) submitted by TAP Pharmaceuticals Inc. (TAP), under Form FDA 2253 (“Heartbreak Hotel,” #TAP-PRV-A9-1 274), violates the Federal Food, Drug, and Cosmetic Act and applicable regulations.  The Division of Drug Marketing, Advertising, and Communications (DDMAC) has reviewed the advertisement and has determined that the advertisement is misleading and lacks fair balance.  Overall, the visuals in the advertisement fail to appropriately communicate Prevacid’s indication, efficacy, and side effect information. DDMAC’s specific objections follow.

Inadequate Presentation of Indication

The advertisement is misleading because it does not clearly communicate Prevacid’s appropriate indication.  TAP discloses the indication limitations using a non-prominent super and song lyric that are difficult to comprehend.  For example, the super, “frequent, persistent heartburn...,” appears faint against distracting visual backgrounds. The information about heartburn persisting despite nonprescription treatments is presented so quickly in the song lyric that the message is difficult to understand.  Thus, without adequate presentation of the limitations, the advertisement implies that Prevacid may be used in a broader range of conditions than approved.  Specifically, the advertisement implies that Prevacid may be used to treat any type of heartburn, rather than the approved indication for short-term treatment of heartburn and symptoms associated with gastroesophageal reflux disease (GERD).

Overstatement of Efficacy

The advertisement is misleading because it implies that Prevacid is more effective than has been proven in clinical trials.  The impact of the benefit presentation, given by the graphics and song lyrics, is not sufficiently qualified by the small, faint, hard-to-read supers of “individual results may vary."  Thus, the advertisement’s overall impression implies that Prevacid will provide relief for everyone all of the time.

Lack of Fair Balance

The advertisement lacks fair balance because it fails to present the information relating to the side effects with sufficient emphasis.  The side effect information is presented in the audio portion of the advertisement along with distracting visual presentations.  The quantity and pace of the visual presentations interfere with the audience’s ability to comprehend the important side effect information.

Requested Response

DDMAC requests that TAP immediately cease using this advertisement and all other promotional materials for Prevacid that contain the same or similar presentations. DDMAC also requests that TAP submit a written response on or before March 27, 2000, describing its intent to comply with the request.  Your written response should include a list of promotional materials that were discontinued and the discontinuation date.

If you have any questions, please contact the undersigned by telephone at (301) 827- 2828, facsimile (301) 594-6759, or by written communication at the Division of Drug Marketing, Advertising, and Communications, HFD-42, Room 17B-20, 5600 Fishers Lane; Rockville, MD 20857.  All communications regarding this matter should reference MACMIS # 8796.  DDMAC reminds you that only written communications are considered official

Sincerely,

Patricia Kuker Staub, Esq. R.Ph. 
Regulatory Counsel 
Division of Drug Marketing, 
   Advertising, and Communications