DDMAC chief criticizes repeating of ad violations. More warnings, fewer untitled letters in store

Dear Reader,

Drug companies can expect some advertising and promotion violations to be treated as warning letters instead of "untitled," or "notice of violation," letters because the Center for Drugs is frustrated with industry's lack of compliance.

Minnie Baylor-Henry, director of the Division

of Drug Marketing, Advertising and Communications (DDMAC), told the Drug Information Assn.'s annual meeting in Boston June 10:

"We are increasingly asking whether an untitled letter should be issued as a warning letter. We know that when companies get an untitled letter, they are celebrating that they've pushed the envelope just enough."

Bristol-Myers Squibb pushed that envelope

too far recently when it received a warning letter for advertising Excedrin Extra Strength in a way FDA said promoted the drug for the same indication as Excedrin Migraine. The ad described the formulations as the same, according to the letter, but FDA argued that it was the difference in labeling that was critical (See page 3). It was one of four letters released on Bristol this month.

Baylor-Henry said public health issues and company repeat offenses are the primary reasons that what might have been an untitled letter will be issued as a warning letter. She also said the agency may look to other enforcement actions, but she did not mention specifics, such as consent decrees, seizures or prosecutions.

"I'm at a loss to understand the mystery of fair balance," she said. "I am not sympathetic to the claim that the industry cannot decipher what that is. 'Fair balance' are words in plain English." Astra, Bristol-Myers Squibb, Carter-Wallace, Hoffman-LaRoche, Janssen Pharmaceutica, Upsher-Smith Labs, Westwood-Squibb Pharmaceuticals and Wyeth-Ayerst Labs each received untitled letters recently, chiding the firms on this matter.

"We are paying close attention to this issue. We have issued over 50 letters [in fiscal 1998]. FDA spends the time to make these letters public. Why are we continuing to see the same violation year after year, not only between companies, but within the same companies?"

She said she is frustrated by the use of "bird-seed-sized fonts" for risk information. "It must be reasonably comparable to the rest of the information," Baylor-Henry explained. "Don't minimize the importance of the risks."

The FDAer explained the rationale for the following DDMAC warning letters and added her own criticisms:

* Roche was cited in a letter for an ad that claimed Accutane had a positive affect on the psycho-social well-being of persons suffering from severe acne. However, Accutane trials revealed an association with depression and suicide, which have not been discounted, she said (Doc. 6314W; March 30 issue, page 3).

* SmithKline Beecham was hit for an ad campaign describing in vitro evidence supporting a conclusion that Relafin, a non-steroidal anti-inflammatory drug, was more selective and superior to others. The warning letter followed previous untitled letters, she said (Doc. 6315W; see March 30 issue, page 2).

* Sonus got a letter for promoting EchoGen on the Internet and in the "Applied Radiology Journal" while the product was an investigational new drug (IND). The letter also warned that promotion of EchoGen at a professional meeting was distinguishable from a valid scientific exchange, Baylor-Henry added (Doc. 6343W; see April 13 issue, page 2).

* Searle received a letter for an ad in "Drug Topics" for Flagyl ER. She said the promo used techniques for prominence, emphasis and readability that led to a decision that the advertisement as a whole lacked fair balance (Doc. 6549W; see June 8 issue, page 2).

"I've never seen an ad quite like the Searle ad," Baylor-Henry said. "The risk information was written in small, black print on a black, or charcoal-grey background. I was unable to read it. This ad reached a new height."

Baylor-Henry also provided specifics on violative advertisements for investigative drugs, such as those that:

* Described the product class and the indication.

* Included a picture of the target organ (an eye) and a statement of the firm's history of quality.

* Stated that the quality of the data was strong enough to support effectiveness.

Other issues that trouble DDMAC, she said, include failure to file information with FDA, using Form 2253, in advance of a promotional campaign. Baylor-Henry said that companies push the filing to the last moment, hoping that DDMAC review will not occur until after the ad campaign is discontinued. Baylor-Henry also said FDA is looking closely at "Coming soon" ads.

"Sometimes it takes us time to appreciate your creativity," she said. "But we'll get it."

Some asked what might constitute acceptable

press releases. "We recognize that there is a reason

for releasing press releases at the end of Phase II for shareholders," Baylor-Henry said. "As long as it is factual, you're going to be fine. Don't include unsupported speculation. Make it clear this is a trial."

She declined to identify Web sites or ads that DDMAC has reviewed and determined to be non-violative, but she did suggest that a DDMAC reviewer responsible for the therapeutic class could express an opinion on the subject.

Another question was whether FDA would slow approval to retaliate against a violative ad issued while the product is under investigation.

David Adams, partner at Olsson, Frank & Weeda, a Washington law firm, responded: "We haven't seen any indication that enforcement by DDMAC has an effect on the approval of applications," and he predicted "continued intense scrutiny" by Congress on DDMAC actions.

Sincerely,

The Editors