MERCK PRINIVIL RIPKEN ADS NEED STRONGER DISCLAIMER, FDA TELLS COMPANY; GEMZAR PROMOTIONS, CLARITIN 1-800 LINE, ULTANE JOURNAL ADS RUN AFOUL OF FDA

Merck's print advertisements for the antihypertensive Prinivil using Baltimore Orioles shortstop Cal Ripken, Jr. should feature a more prominent disclaimer emphasizing that Ripken is not endorsing the product. "The disclaimer that Mr. Ripken is not hypertensive and does not take Prinivil lacks significant prominence and does not balance or clarify the misrepresentation of the product endorsement," DDMAC states.

The Ripken ad is on the back page of the March 27 New England Journal of Medicine. Merck launched the campaign in January and had planned to continue it throughout the year ("The Pink Sheet" Feb. 17, T&G-4). The March 10 DDMAC letter instructs Merck to discontinue the ad and similar materials "immediately."

"The claim `Both On the Job. Everyday' is a misrepresentation in the context in which it is presented," DDMAC asserts. "In these promotional materials, it appears that Mr. Ripken is endorsing Prinivil. However, Mr. Ripken does not take Prinivil and does not have hypertension."

Lilly's promotions of Gemzar (gemcitabine) for non-small cell lung cancer at a March oncology seminar at Bethesda National Naval Medical Center elicited a citation from FDA in a March 19 letter.

At the seminar, "a Lilly representative disseminated reprints of articles, abstracts and a summary of published studies, all of which describe the use of Gemzar in non-small cell lung cancer," the letter states. Lilly was also censured for failing to submit the violative materials to DDMAC for review.

Gemzar was approved in 1996 for treatment of advanced or metastatic pancreatic cancer. Some insurers are covering Gemzar for NSCLC use off-label ("The Pink Sheet" Nov. 11, 1996, p. 5). A fall 1997 filing for a NSCLC indication is planned, according to Lilly's most recent annual report. Lilly is requested to "immediately discontinue the use of any and all promotional materials that promote Gemzar for an unapproved use" and "provide FDA with a list and copies of any and all other promotional materials in use by Lilly sales representatives that have not been submitted to FDA," the letter states.

Schering-Plough was cited in a March 10 DDMAC letter for lack of "adequate provision of the approved product labeling" in its toll-free telephone information line for Claritin. "The 1-800-CLARITIN telephone script recording represents a full product ad in the form of a broadcast ad," DDMAC states.

"According to the Claritin telephone recording, the Claritin product materials would be received by the caller `within the next few days,'" DDMAC reports. "DDMAC does not consider a two-three week actual response time for receipt of the Claritin approved product labeling to meet the `adequate provision' requirement (as was the circumstance recently when this 1-800 number was called)." Schering attributed the problem to a computer transition at the order fulfillment contractor and said the matter has been resolved with FDA. In a March 28 Federal Register notice, DDMAC said that it plans to revise its guidance regarding telephone advertisements.

An Ultane (sevoflurane) ad in the October 1996 Anesthesiology drew FDA fire for the breadth of its claims. In a March 17 letter to Abbott, DDMAC objected to claims that "in every patient" and "in every procedure...you'll find another critical reason to choose Ultane." As with the Gemzar promotion, FDA took the company to task for failing to submit the ad "at the time of initial dissemination."

Ultane labeling warns of risks or uncertainties associated with administration in sevoflurane-sensitive patients, patients with renal insufficiency, patients with severe hepatic dysfunction, pregnant women and during childbirth, FDA notes.

In addition, the ad "is lacking in fair balance because it fails to give any emphasis to information on side effects and contraindications in comparison to claims of effectiveness," the agency asserts. In the Federal Register notice, DDMAC announced that it plans to revise its "fair balance" guidance.