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The Record, Hackensack, N.J., Kevin DeMarrais column: DeMarrais: FDA wants risks listed in Web drug ads
Nov 06, 2009 (The Record - McClatchy-Tribune Information Services via COMTEX) --
Is one click enough?
That is the crux of a debate between the Food and Drug Administration and the nation's biggest drug companies in a clash over applying rules written in an analog era to a digital world. The outcome will determine how prescription drugs are marketed to consumers.
At issue is whether risk information has to appear at the first mention of the drug in an Internet ad, or whether it can be a click away on a secondary screen.
Next week the FDA will hear arguments for updating its rules during a two-day hearing that will help it develop rules for marketing prescription drugs and devices on the Internet and through social media such as Facebook and Twitter.
Under federal law, all advertising and promotional materials for prescription drugs must list risks, even if the ad includes little more than the name of the drug and the condition it is intended to treat.
Risk information "helps consumers know whether drugs or devices may be appropriate for them as well as what they should tell their health care professionals about before taking or using ... a product," the FDA says in a draft proposal for new rules.
"It also lets consumers know what risks they might experience and what steps they need to take for safety reasons (e.g., no driving) because of taking or using a product," the FDA says.
The question is where that information should go.
Until last spring, when the drug companies promoted their products in short ads on Internet search sites, such as Google and Yahoo, consumers were directed to the risk information on another page. That's because space limits -- often a maximum of one or two lines -- prevented them from listing potential problems and adverse reactions in the ad.
After all, that's essentially what is done with television ads (which refer viewers to a print source for detailed information) or with newspaper and magazine ads (in which the risks are often printed on an adjoining page).
Not good enough, the FDA said.
In strongly worded warning letters sent in March to 14 major pharmaceutical firms, regulators said that listing some benefits, without including risk information, violated federal rules.
The sponsored links for five named drugs "fail to communicate any risk information associated with the use of these drugs," Dr. Shefali Doshi, an FDA regulatory review officer, wrote to Whitehouse Station-based Merck.
"For promotional material to be truthful and non-misleading, they must contain risk information in each part as necessary to qualify any claims made about the drug."
As a result, the agency "requests that Merck immediately cease the dissemination of violative promotional materials" for the five drugs cited, Doshi wrote.
Similar letters went to the other companies.
The fact that it is almost impossible to include the risk information within space limitations -- Google search ads allow just 95 characters -- didn't matter, the FDA said. Include the risks or remove the ad.
"The treatment of risk information in each piece should be comparable to the treatment of benefit information," the FDA said.
But to critics, including the Competitive Enterprise Institute, a conservative Washington-based think tank, it's a matter of moving from a "1960s approach" to the realities of the 21st century.
"For over a decade, the FDA has treated the Internet as just another form of print advertising," said Gregory Conko, a senior fellow at the CEI.
"Internet ads have had to comply with rules that simply don't make sense in the Internet Age, where the amount of text available in a banner ad or sponsored link is strictly limited, but the required information can be 'one click' away on the landing page to which those ads direct the user," he said.
The hearings on Thursday and Friday give the companies an opportunity to provide input as the FDA develops its policy, said Ron Rogers, a Merck spokesman.
"As we follow the evolving social media technologies and the regulations around this new space, we are giving careful thought on how best to harness social media to achieve specific business goals," he said.
Those goals may clash with FDA policy, and when that happens, the FDA has the final word.
In evaluating advertising, the FDA "considers the net impression conveyed by all the elements of a piece" using "the reasonable consumer standard," the agency says in its draft guide.
"For this reason, manufacturers should focus not just on individual claims or presentations, but on the messages conveyed by the promotional piece as a whole."
E-mail: demarrais@northjersey.com
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http://www.northjersey.com. Copyright (c) 2009, The Record, Hackensack, N.J.
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