Two of FDA's most recent warning letters reinforce a point made in the 14 letters issued earlier for volatile Internet search links: when making promotional claims, leave no risk information behind - on any page.

The agency's Division of Drug Marketing, Advertising, and Communications cited a professional journal ad for Dexcel Pharma's oral care product PerioChip (chlorhexidine gluconate) and two sales aids for Cornerstone Therapeutics anti-infective Spectracef (cefditoren pivoxil) in letters sent May 14 and May 4, respectively.

Another warning letter, citing Johnson and Johnson's Ultram ER , expressed concern about patient testimonials (see ¹ Also see "Patient Testimonials In Web Ads Continue To Be Target Of FDA Warning Letters" - Pink Sheet, 20 May, 2009. ).

FDA claims that ads for both PerioChip and Spectracef did not include sufficient risk information, but of the two products, Spectracef appears to be the more serious offender.

FDA notes that in addition to omitting risk information, the Spectracef sales aids also contain unsubstantiated superiority claims and misleading dosing claims as well as overstating efficacy and broadening the indication. While the PerioChip journal ad is cited for false and misleading claims, overstating efficacy, misleading claims and omitting material facts.

Critics of the agency's recent spout of letters concerning sponsored links argue that including risk information within "one click" is akin flipping the page of a magazine to view Brief Summary information in a print ad, which has been perceived as a sort of fail-safe rule of thumb (² Also see "Internet Promotions Must Be Redesigned After FDA Cites Sponsored Web Links" - Pink Sheet, 13 April, 2009., p. 32).

But DDMAC officials asserted that risk information must be included on every page that makes a promotional claim - in electronic or print format - without exception, during a panel addressing drug marketers at a recent DTC Conference in Washington, D.C.

One month later, the agency is adding actions to its words.

In the PerioChip letter, FDA notes that though the Brief Summary is included on the second page of the journal ad, "this is not sufficient to provide appropriate qualification or pertinent information in each part as necessary to qualify any safety or effectiveness claims made."

FDA also cautions against improper use of studies cited to back promotional claims, in the same letter. Dexcel, for example, claimed that use of PerioChip plus SRP resulted in a "clinically meaningful improvement compared to SRP alone." DDMAC says that the article referenced in a footnote on the claim "does not constitute substantial evidence" because it was not designed to look at the issue prospectively.

Similarly, FDA cites the Spectracef sales aids, which include brief summary information on the center pages, for including risk information "solely in this distinct part of the sales aid," which is "not sufficient to provide appropriate qualification or pertinent information for claims made in the main promotional parts of the sales aids."

"For the pieces to be non-misleading, they must contain the limitations to the indication in each part as necessary to qualify any safety or effectiveness claims made in that part," the letter continues.

Advertising Letters In '09 Already Top '08

The surge of FDA drug advertising letters so far this year - 23 including warning and "untitled" letters - suggests drug makers are still fuzzy about what constitutes volatile promotion, especially on the Internet where the agency has not issued formal guidelines. Letters issued to date already top the 22 sent in all of 2008.

But, an increasingly strict regulatory environment appears to be making drug makers aware of promotional 'dos' and 'don'ts' the hard way, Arnold Friede of McDermott Will & Emery suggested during a DTC Webinar sponsored by Elsevier Business Intelligence May 20.

"The message we're hearing from DDMAC is be wary ... the cop is on the beat, so to speak, at least now," Friede said.

-Carlene Olsen (c.olsen@elsevier.com)

FDA Stresses Importance Of Fair Balance; Warning Letters Continue To Climb In 2009

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