DDMAC's Abrams gives update on policy making

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Abrams: seeing how complex the issues are
Abrams: seeing how complex the issues are

The director of the FDA's Division of Drug Marketing, Advertising and Communication (DDMAC) could not give a completion date for guidelines on use of social media in promotion. But in a status report on the division's policy-making efforts, Tom Abrams said this year the agency will issue a process for implementing a 2007 law requiring drug firms to pre-submit some TV ads.

DDMAC had set a 2010 deadline for developing the social media guidance. In December, the agency said a policy for using at least one social media tool will appear by March. One reason for the delay has been the FDA's tedious rule-making process, another the complexity of social media itself.

“We want to have these guidances out as soon as possible,” Abrams told a crowd of several hundred at ePharma Summit in New York. “Honestly, [it's] taking longer than we thought, not because of lack of resources—we actually increased our resource allocation—we are seeing how complex the issues are. And we want to get this right. We owe it to you to get this right.”
 
The agency collected public input during a two-day hearing in 2009, reviewed comments and decided against issuing rules for specific social media platforms like Twitter, Facebook or YouTube. “Those things are really in now, but…two years from now, who knows?” said Abrams. “We did not want the guidances to become quickly outdated.”
 
Moreover, he said, questions from people in the industry did not pertain to specific platforms but to specific issues: how to respond to unsolicited requests for comment and how to correct misinformation on a third-party website, for instance. (Abrams said final rules will include examples involving specific platforms.)

Its 2011 policy pipeline includes a number of other guidances, as well. In 2007, the FDA Amendments Act, the first law to address DTC promotion per se, gave FDA the authority to levy civil monetary penalties for violative DTC ads. It also included a provision to require companies to submit some TV ads 45 days before airing, not as a pre-clearance but as a pre-submission requirement.

“We will come up with a guidance this year of what products and categories of TV ads we expect to be submitted,” said Abrams.

DDMAC is also studying whether it's beneficial to require TV ads to include FDA's toll-free MedWatch number and website for adverse events reporting, like print ads are required to do; is examining comments to a rule proposed in March 2010 on the way benefits information is presented; and is revising brief summary draft guidance, based on comments received to a proposed rule and data analysis from three studies.

The 2010 Patient Protection and Affordable Care Act also contained a provision regarding Rx drug promotion, requiring DDMAC to determine whether a drug facts box, like the one on OTC labels, that contains quantitative studies in a standard format would improve healthcare decision-making. DDMAC is consulting with experts in this area, Abrams said.

The division's 65 staffers review promotional materials to ensure Rx drug promotion is not false or misleading, is balanced and aids communication to the public. It can cite violators by issuing untitled letters or the more serious warning letters. In 2010, DDMAC sent 52 such letters, following 41 in 2009 and 21 in 2008.

Despite issuing draft guidance on risk information in 2009, omission and minimization of risk information “has been and continues to be” the most common set of violations in prescription drug promotion, Abrams noted, adding that the division is putting more resources into voluntary industry compliance and to reviewing the 79,000 promotional pieces it receives per year. Last year's Bad Ad program—in which the agency encourages healthcare providers to report violative sales force presentations, dinner meetings or speaker meetings—should enhance its monitoring. And the planned elevation of DDMAC to an FDA office this year should help with some of these efforts, Abrams said.
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