Under direction from Congress, FDA is examining whether television drug advertising can improve patient health and spur consumers to report adverse events. FDA's Risk Communication Advisory Committee—a new panel of social scientists that advises FDA on these matters—discussed these issues at a meeting last week.

Consumer advocates urged a speedy decision on the TV adverse event reporting policy, which FDA says will take two years to institute. But no one from industry stepped up with evidence that DTC advertising could be useful in accomplishing public health goals, or in educating patients about appropriate drug use—something that marketers regularly cite in fending off attacks on TV drug advertising.

The FDA Amendments Act (FDAAA) calls for FDA to study whether displaying an 800 number in TV ads will interfere with communication of important risk information. The legislation already requires such information to print ads, but the policy has been held off on broadcast ads pending further evaluation of how best to present the information.

"The typical 60 second spot in pharma, allowing for fair balance, has time for just five sentences of focused promotional copy," said Jay Carter, Sr. VP, director of client services at AbelsonTaylor in an interview on Tuesday. "Adding an 800 number for FDA would likely cut the promotional copy in a sixty-second spot to an average of four sentences from five. I am not arguing that we should not include fair balance, I am merely pointing out such additions distract from the central message of an advertisement, which is of course why marketers spend money to run ads."

The topic got plenty of discussion at the advisory committee meeting, with the consensus that displaying an 800 number would indeed reinforce the idea that drugs have adverse events, and that there is a way to report problems to FDA. While the call-in information may clutter up commercials, marketers could gain credibility by testing various approaches for including this information in ads, rather than waiting for FDA to rule on the issue.

Similarly, marketers probably know much more than academics and members of Congress about just how effective TV commercials are at communicating important health information to target patient populations—such as the elderly, children, blacks, Hispanics and other minorities. Congress is interested in reducing disparities in health problems for these groups, and has instructed FDA to assess how DTC advertising can prompt these target populations to seek information, and whether there is any health improvement as a result.

The advisory panel learned that there is scant data available on these issues, providing industry with a prime opportunity to gather that information or disclose some of its proprietary data documenting those kinds of values to DTC advertising.

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Feds consider adding an 800 number to television ads for adverse event reporting. Does this shine light on DTC ads while pushing public health goals? Industry is mum on the topic

Dial FDA: Marketers Face Added DTC Requirements

The American Red Cross (ARC) won a victory against Johnson & Johnson last week in a trial that had turned into a David versus Goliath battle over a symbol synonymous with help and unity—the red cross.

Federal Judge Jed Rakoff sided with ARC, ruling that the charity organization had the legal right to use the symbol on packaging of products it sells, including first aid kits.

"We are thrilled about the judge's ruling, because it means that we can continue to use our emblem on products that help facilitate our mission and provide consumers with products that help protect their families," ARC spokesperson Mary Havell told 

 on Tuesday. "It's been a shame that we had to waste our valuable resources that should have been devoted to helping people affected by disasters and helping to save lives."

The Red Cross has been using the symbol since 1881, nearly a quarter of a century before J&J trademarked the same symbol in 1905. The two organizations used the symbol with no conflict for over a century. But in August 2007, J&J sued ARC, claiming that ARC was illegally using the emblem to market products?in effect, breaking agreement that ARC could use the cross as long as it wasn't for the sale of goods.

 of "promissory estoppel," agreeing with the ARC that without a physical document, the agreement could not be proven.

"We are disappointed that the court rejected our claims involving ARC's commercial uses of the emblem," J&J's director of corporate communications Marc Monseau stated on the company blog. "We are reviewing the decision, and look forward to continuing this process to resolve our legal dispute with the American Red Cross."

A hearing is set for July 8 on the remaining issues in the lawsuit, but ARC sees last week's ruling as a major victory.

American Red Cross scores a win against Johnson & Johnson in a legal battle over the use of one of the healthcare?s most recognizable symbols

Red Cross Gets OK to Market Emblem

 from FDA's Division of Drug Marketing, Advertising, and Communications last week for improper promotional material associated with the renal disease treatment Fosrenol.

In question is a notebook and medical exam light case distributed to physicians at a renal disease conference. FDA disapproved of the phrases "First line," "For reductions that last," and "Calcium-Free," all of which were included in the promo material. The agency stated in its letter: "Reminder pieces may not include, among other things, representations or suggestions concerning effectiveness or patient population."

FDA defines reminder labeling as any material that includes the name of the drug, but does not promote it through dosage recommendations, indications, or other uses. Promo pieces considered reminder labeling do not have to include risk information or drug indication in accordance with 21 CFR 201.100(f).

Shire's Director of Communications Matt Cabrey told 

 on Tuesday that they responded to FDA and are fully complying with the Feds. "This material was not intended initially to be an item that was detailed by representatives in the field at physicians offices," Cabrey said. "We absolutely agree with FDA's assessment, and we are committed to following FDA guidelines so that we are in compliance with regulatory requirements."

He characterized this situation as a review process oversight, and said that Shire now has a much clearer understanding of the red flags it must look for prior to producing promotional material.

"The rules are arcane, but FDA says a manufacturer can run 'reminder' ads with just name of product, as long as there's no suggestion of the benefit," said Mel Sokotch, former ad exec at Foote Cone & Belding and Grey Advertising. "Pfizer got into trouble with a reminder ad for Viagra that featured a middle-aged man [telling his wife] that the guy she married 'way back when' is back." Although the advertisement only mentioned Viagra, the commentary suggested that Viagra helped him get his libido back.

"The Shire case is far subtler," Sokotch said. "FDA obviously felt that the combination of logo and copy amounted to a communication of the med's benefit, and the benefit must always be balanced with the warnings."

FDA takes the opportunity to remind industry what reminder ads are, as promotional material for Shire's Fosrenol is deemed in violation of advertising rules

Pharmaceutical Executive-05-21-2008

Dial FDA: Marketers Face Added DTC Requirements

Red Cross Gets OK to Market Emblem

Shire Reminder Promo a No No