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Drug Cos. To Submit TV Ads to FDA

Drug manufacturers have adopted a new voluntary code for direct-to-consumer ad guidelines, including submitting TV ads to the FDA before they run, better balancing risk and benefit info in those ads, banning "reminder" ads that don't include educational information, and targeting ED ads to appropriate age groups.

ED ads, including one in the 2004 Super Bowl, helped prompt some of the most recent outcry over DTC ads.
Drug companies already discuss upcoming ad campaigns for new drugs, but submitting the ads before running is new.
The new guidelines, which should be fully reflected in ad campaigns by the end of the year, also recommend a medicine-specific waiting period for the introduction of DTC ads. "If it takes a year [to educate health care professionals], it will be a year, if it's six months, it's six months," said Pharmaceutical Research and Manufacturers of America (PhRMA) President Billy Tauzin (former House Commerce Committee Chairman), who announced the guidelines.

Johnson & Johnson, Merck, Novartis, and 20 other companies have already signed on to the guidelines.
The industry has been getting heat from Washington over DTC advertising and its relationship to the skyrocketing costs of healthcare.

PhRMA announced June 21 that its board had approved the broad outline of new guidelines for DTV ads, but that did not stop Majority leader (and doctor) Senator Bill Frist from calling for a two-year moratorium on DTV ads for prescription drugs, then FDA review and approval of ads when they did run.

Frist said the ads lead to "inappropriate prescribing" and that they can "oversell benefits and undersell risks."

Tauzin said Tuesday that the guidelines were all meant to address Frist's concerns "in some form or another." Tauzin thanked his former colleague for prompting the dialog "that led to this day."

The Association of National Advertisers added in a statement that the new guidelines should also preclude threats of government regulation of DTC ads.

In a statement, Frist said: "While I wish the PhRMA guidelines would have gone farther and proposed a moratorium on DTC advertising of newly approved drugs, I hope individual pharmaceutical manufacturers will seriously consider such a measure."
Tauzin responded that anti-trust regs prevented companies getting together to set such a delay, which is why the guidelines suggested medicine-specific delays on a case-by-case basis.
PhRMA said it will also create a panel to review consumer input on DTC ads and report those findings to the board.
The PhRMA guidelines, now officially adopted by the board as of last Friday (July 29),  include:

1) "Conversations with physicians prior to the launch of a new direct-to-consumer campaign.

2) "TV advertisements targeted for audience and age appropriateness. Companies should promote health and disease awareness as part of their advertising.

3) "Companies are encouraged to include information about assistance programs for the uninsured and low-income.

4) "Additionally, to help achieve better consumer education, the principles say all direct-to-consumer advertising “should be accurate and not misleading; make claims only when supported by substantial evidence; reflect balance between risks and benefits; and be consistent with FDA-approved labeling.”