AZ proposes mandatory DTC review

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AstraZeneca is calling for a mandatory FDA review of all DTC ads prior to their use, provided that the agency can conduct reviews within a specific timeframe.
The drug maker made the recommendation in written testimony submitted to an FDA public hearing on DTC drug promotion being held today and tomorrow.
"If our collective goal is to ensure that accurate and responsible information is communicated to patients and health care providers, then manufacturers, patients, physicians and policymakers ought to welcome such a review process," said Tony Zook, AstraZeneca senior vice president, commercial operations, and president and chief executive designate, in a statement.
Under the proposed system, drug companies would submit all consumer-directed ads to the FDA's Division of Drug Marketing and Communication (DDMAC) for prior review.
AstraZeneca would support legislation making this mandatory, "but only where DDMAC has the necessary resources to conduct its review within a specific timeframe," the company said in a press release outlining the proposal.
Pre-submission would provide an alternative to FDA's current reactionary practice of sending warning letters to drug makers when DTC ads run afoul of the Federal Food, Drug, and Cosmetic Act and implementing regulations. In the past such letters often have arrived after a campaign has run its course.
"Requiring FDA to review and comment on an advertisement prior to its use should preclude a subsequent finding by the FDA that the advertisement is misleading or inaccurate," the statement said.
Manufacturers would integrate the comments into the ad as appropriate, but the FDA would maintain the right to halt the ad if, following its approval, new scientific or medical information came to light.
The drug maker also said it is supporting what it calls the first large-scale consumer research study on the use of fair balance in television commercials. Results are expected early next year, it said.
Recent TV ads for Crestor (rosuvastatin) and Nexium (esomeprazole magnesium) are "educational in content and serious in tone," reflecting AZ's adherence to the voluntary PhRMA Guiding Principles on DTC Advertisements, which the firm signed on to in August, the company added.
Industry figures rallied to the defense of consumer advertising at this morning's hearings, providing a minority counterpoint to a litany of often vague complaints from academics and consumer activists.
"There is no scary Halloween scenario around DTC," said John Kamp, director of the Coalition for Healthcare Communication. "DTC advertising works." Kamp said that while the FDA should perform a systematic review of its consumer advertising policies, DTC advertising is an important tool in helping patients become aware of new drug options and encourages compliance.
"The current scheme is not broken, so lets be careful as we tinker with it so as to avoid fixes that break it," Kamp said.
"DTC is important and effective," said Pat Kelly, president of Pfizer's U.S. pharmaceuticals division. "The record shows that DTC advertising benefits consumers and healthcare more broadly by raising consumer awareness, prompting more Americans to have important conversations with their healthcare providers."
Kelly said that although DTC advertising has been a target of recent
criticism, it is important to remember that the marketing method should not be viewed as a comprehensive way to educate patients.
"DTC advertising is, and should remain, a catalyst that drives consumers to get the full depth of information about prescription medicines, something they pursue through a variety of sources, including their healthcare providers," Kelly said.
Kelly called for more research "on how the beneficial effects of DTC
advertising should be weighed against the possibility that some risk
information might not be totally imparted to everyone within the four corners of each advertisement itself."

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