FDA Proposes to Ease Rules for Pharmaceutical Ads on Social Media
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ADVERTISING, MARKETING & PROMOTIONS >> ALERT FDA PROPOSES TO EASE RULES FOR PHARMACEUTICAL ADS ON SOCIAL MEDIA Recently, the Food and Drug Administration (FDA) issued a draft guidance that proposes to make advertising prescription products on social media less burdensome. The draft guidance sets forth the FDA’s current thinking about its postmarketing submission requirements in the context of “interactive promotional media” such as blogs, microblogs, social networking sites, online communities, and live podcasts that pharmaceutical companies use for promotional purposes. “THE TIME OF INITIAL DISSEMINATION” As part of the postmarketing reporting requirements under the Federal Food, Drug, and Cosmetic Act, pharmaceutical companies are required to submit all prescription drug promotional labeling and advertising pieces at the time of initial dissemination of the labeling and at the time of initial publication of the advertisement. The draft guidance recognizes, however, that for some forms of social media, submission “at the time of initial dissemination” may pose a challenge, particularly when these media communicate information that is displayed in real time. The draft guidance states that although “at the time of initial dissemination” does not refer to submissions on a weekly, monthly, or other routine schedule, the FDA “intends to exercise its enforcement discretion” under certain circumstances due to the high volume of information that may be posted within short periods of time using interactive promotional media that allow for real-time communications. The draft guidance provides a safe harbor for pharmaceutical companies that submit interactive promotional media in the manner the FDA describes. The draft guidance highlights three factors that the FDA will consider in determining a pharmaceutical company’s responsibility for submitting interactive promotional media to the FDA. THREE FACTORS Factor 1. The draft guidance provides that a pharmaceutical company “is responsible for” product promotional communications on sites that are “owned, controlled, created, influenced, or operated by, or on behalf of,” the company. In other words, in determining whether a company must submit promotional material about its products, the FDA will consider whether the company, or anyone acting on its behalf, is influencing or controlling the promotional activity or communication in whole or part. Factor 2. A pharmaceutical company may be responsible for promotion on third-party sites where it has “any control or influence” on the third-party site, even if that influence is limited in scope. However, if a pharmaceutical company provides JANUARY 2014 Attorney Advertising 1460 THE BOTTOM LINE Comments are due on the FDA’s draft guidance within ninety days. Further FDA action on postmarketing submission requirements – and other social media marketing issues – may come this summer when it issues guidance regarding the promotion, using the Internet (including social media), of medical products subject to its jurisdiction, as required by the FDA Safety and Innovation Act. >> continues on next page
Transcript of FDA Proposes to Ease Rules for Pharmaceutical Ads on Social Media
ADVERTISING, MARKETING & PROMOTIONS
>> ALERT FDA PROPOSES TO EASE RULES FOR PHARMACEUTICAL ADS ON SOCIAL MEDIARecently, the Food and Drug Administration (FDA) issued a draft guidance that proposes to make advertising prescription products on social media less burdensome. The draft guidance sets forth the FDA’s current thinking about its postmarketing submission requirements in the context of “interactive promotional media” such as blogs, microblogs, social networking sites, online communities, and live podcasts that pharmaceutical companies use for promotional purposes.
“THE TIME OF INITIAL DISSEMINATION”As part of the postmarketing reporting requirements under the Federal Food, Drug, and Cosmetic Act, pharmaceutical companies are required to submit all prescription drug promotional labeling and advertising pieces at the time of initial dissemination of the labeling and at the time of initial publication of the advertisement. The draft guidance recognizes, however, that for some forms of social media, submission “at the time of initial dissemination” may pose a challenge, particularly when these media communicate information that is displayed in real time.
The draft guidance states that although “at the time of initial dissemination” does not refer to submissions on a weekly, monthly, or other routine schedule, the FDA “intends to exercise its enforcement discretion” under certain circumstances due to the high volume of information that may be posted within short periods of time using interactive promotional media that
allow for real-time communications. The draft guidance provides a safe harbor for pharmaceutical companies that submit interactive promotional media in the manner the FDA describes.
The draft guidance highlights three factors that the FDA will consider in determining a pharmaceutical company’s responsibility for submitting interactive promotional media to the FDA.
THREE FACTORSFactor 1. The draft guidance provides that a pharmaceutical company “is responsible for” product promotional communications on sites that are
“owned, controlled, created, influenced, or operated by, or on behalf of,” the company. In other words, in determining whether a company must submit promotional material about its products, the FDA will consider whether the company, or anyone acting on its behalf, is influencing or controlling the promotional activity or communication in whole or part.
Factor 2. A pharmaceutical company may be responsible for promotion on third-party sites where it has “any control or influence” on the third-party site, even if that influence is limited in scope. However, if a pharmaceutical company provides
JANUARY 2014
Attorney Advertising1460
THE BOTTOM LINE
Comments are due on the FDA’s draft guidance within ninety days. Further FDA action
on postmarketing submission requirements – and other social media marketing
issues – may come this summer when it issues guidance regarding the promotion,
using the Internet (including social media), of medical products subject to its
jurisdiction, as required by the FDA Safety and Innovation Act.
>> continues on next page
>> ALERT
JANUARY 2014
ADVERTISING, MARKETING & PROMOTIONS
only financial support (e.g., through an unrestricted educational grant) and has no other control or influence on that site, then the company is not responsible for information on the third-party site, and has no obligation to submit the content to the FDA. If a company merely provides promotional materials to a third-party site but does not direct the placement of the promotion within the site and has no other control or influence on that site, then the company is responsible only for the content it places there and is responsible only for submitting to the FDA the promotional content disseminated on that site.
Factor 3. A company is responsible for the content generated by an employee or agent who is acting on its behalf to promote its product. For instance, if a pharmaceutical company’s representative, such as a blogger it pays, maintains a blog about its product, the company is responsible for submitting the blog to the FDA to meet the postmarketing submission requirements.
SUBMISSION TIMINGIn the draft guidance, the FDA acknowledges the challenges of submitting promotional materials
that display real-time information. The FDA intends to exercise enforcement discretion for interactive promotional media submitted in accordance with its recommendations. (The draft guidance does not alter the FDA’s expectations for submitting static promotional materials that are substantially similar to traditional promotional materials in presentation and content.)
First, the draft guidance recommends that, at the time of initial display, a company should submit in its entirety all sites for which it is responsible. For example, a company should submit the comprehensive static product website with the addition of the interactive or real-time components.
Second, for third-party sites on which a company’s participation is limited to interactive or real-time communications, the company should submit the home page of the third-party site, along with the interactive page within the third-party site and the company’s first communication at the time of initial display.
Third, the draft guidance states that, once every month, a company should submit an updated listing of “all
non-restricted sites for which it is responsible or in which it remains an active participant and that include interactive or real-time communications.”
The draft guidance also provides that where a site has “restricted access,” a company should submit all content related to the discussion to “adequately provide context to facilitate the review,” and that screenshots or other visual representations of the actual site, including the interactive or real-time communications, should be submitted monthly.
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