CIBA Pharmaceutical Co. confirmed yesterday that it held up an expensive test newspaper advertising campaign for a new heart drug after the Food and Drug Administration warned that consumers might be misled.
The drug is Transderm-Nitro. The FDA approved it last year for the prevention and treatment of angina pectoris arising from coronary artery disease. Like two rival products, it provides a continuous, 24-hour controlled release of nitroglycerin through a membrane attached to the skin.
CIBA is the first pharmaceutical manufacturer to be induced by the agency to pull back a public promotion of a medicine available only by a doctor's prescription, Dr. Lloyd G. Millstein, acting director of the Division of Drug Advertising and Labeling, said in an interview.
Such promotions, which have mushroomed over the last year, stimulate patients to demand particular drugs -- sometimes to the distress of physicians. The FDA does not object to the idea of consumer ads, Millstein said. Rather, it simply wants the ads to provide "the absolute truth in a balanced manner."
CIBA had scheduled a full-page Transderm-Nitro ad daily for six weeks in the Chicago Tribune, Houston Post and Cleveland Plain-Dealer. Then, after a month's pause, the daily ads were to be resumed for a second six-week period.
On Oct. 27, five days before the campaign was to start, Dr. Ronald R. Gauch, CIBA's regulatory affairs chief, showed the ad to Mary Doug Tyson, Millstein's assistant. Preclearance, while voluntary under the drug law, can protect against after-the-fact complaints, such as those the FDA made against Eli Lilly and Co. concerning the safety and effectiveness of Oraflex, a prescription arthritis medicine that since has been withdrawn.
Gauch requested a response within four hours, according to internal FDA papers. CIBA spokesman Joe Boyd said in Summit, N.J., yesterday that the company thought four hours was adequate because it believed that the ad conformed with FDA policy and so "anticipated no problems." He also stressed that submission of the ad to the FDA was voluntary. Millstein said that a reasonable time for a review is a week to 10 days, possibly two weeks.
In a letter to Gauch the day of his visit, Tyson emphasized that the FDA had given only conditional marketing approval to application-to-the-skin nitroglycerin products pending completion of a review of data on their effectiveness. In the interim, the FDA believes that any promotion to the general public without adequate disclosure of the conditional approval "may be misleading to consumers" and prefers that no such campaign be launched, she wrote.
If the ad is to run, CIBA should disclose the efficacy review, delete a claim that Transdermal-Nitro makes anginal attacks fewer, shorter, and milder, and clarify a claim that it "replaces other preventive medication," Tyson continued.
She closed by warning that, if the FDA's advice is ignored, the agency will require CIBA to follow the planned ad with a corrective ad in the same newspapers after the effectiveness review is done.
Millstein also cautioned CIBA in a follow-up phone call Thursday, the morning after Gauch's visit. The company "would be at risk should it run this ad," he said in a memo.
At 8 a.m. on Friday, Oct. 29, an aide to Gauch phoned Millstein to report that the ad would not run as scheduled.
Tyson, in a Nov. 1 memo saying she expects CIBA "will come back to us," wrote: "I think it only fair to them that we search for alternatives to meet their goals and ours, too, rather than taking a 'no-way' attitude. I'm also concerned that a company less cooperative than CIBA will think of the same idea and we won't have a leg to stand on."