FTC Dons Sheriff's Badge in Wild West of Social Media
By Mari Serebrov
The taming of the Wild West of social media has begun, with the FTC reinforcing its role as sheriff. To keep the peace and help drugmakers and other industries ride through the new digital territories unscathed, the FTC updated its 13-year-old ".com Disclosures" guidance.
While the guidelines provide more insight on the placement of disclosures and the use of hyperlinks, they don't begin to address all the dangers awaiting drugmakers in the social media frontier boom towns. For direction on placement of risk information, third-party posts and avoidance of off-label promotion, biopharma will have to wait until next year for the FDA to ride in with its guidance – if the agency meets the deadline imposed by Congress in the FDA Safety and Innovation Act. (See BioWorld Today, Aug. 21, 2012.)
Although the FDA promised such guidance a few years ago, it missed its self-imposed deadlines and has yet to include the guidance on its annual to-do list. Now that the FTC has acted, the FDA may borrow a page or two from the other agency. (See BioWorld Today, Jan. 17, 2011, Jan. 11, 2012, and Feb. 7, 2013.)
The FTC guidelines make it clear that the principles adopted in the past for print and broadcast advertising also apply to the newer digital platforms. In other words, ads posted on social media have to follow the same truth-in-advertising and consumer protection laws that apply to any other ads.
The guidelines posted this week to the FTC website deal strictly with disclosures and reflect technological advancements and marketing developments that have emerged since the turn of the 21st century. When the FTC announced that it was working on an update last year, it acknowledged the challenges that have cropped up in the proliferation of blogs, tweets and "likes" that make it difficult to tell if a claim is a sponsored ad.
Under the new guidelines, if a disclosure is needed to keep an ad from violating an FTC rule or being deceptive or unfair, the disclosure must be clear and conspicuous on all devices and platforms on which the ad might be displayed.
One big change from the .com guidance issued in 2000 is the placement of disclosures. The old guidance said disclosures should be "near, and when possible, on the same screen" as the relevant claim. Now the FTC is saying they should be "as close as possible," even in space-constrained platforms like Twitter. Putting the disclosure in a pop-up doesn't work, the FTC said, because pop-ups are often blocked.
While hyperlinks may be used for some disclosures, they're totally out of bounds for ones dealing with cost, health or safety issues. That means health- or safety-related disclosures on a Twitter ad would have to be squeezed into the same 140-character tweet as the claim.
Between the lines of the guidance is the warning that companies who want to be part of social media must keep up with how those digital spaces work, both technically and behaviorally. For instance, when hyperlinks are used, they must be labeled as specifically as possible, and the company must consider how the links would function in various programs and devices.
The advertiser must assess the effectiveness of the hyperlinked disclosure by monitoring click-through rates and other information about consumer use and then make changes accordingly, the FTC said.
Ads should be designed so consumers don't have to "scroll" down to the disclosure. If scrolling is necessary, text or visual cues should be used to encourage consumers to scroll to the disclosure. Companies are to keep up with empirical research about where consumers look on a screen and recognize and respond to technological limitations or unique characteristics of specific media when making disclosures.
Other recommendations include using audio disclosures when making audio claims and displaying visual disclosures long enough for consumers to read them.
But "rather than focusing on fonts, hyperlinks, proximity, platforms and the whole disclosures rigmarole," the FTC suggested companies step back and reformulate their claims so no disclosure is needed.
Recognizing that new social media issues arise almost as fast as the technology develops, the FTC said it will continue to evaluate online advertising, applying its traditional criteria to the new frontiers.
GPhA: Shorter Exclusivity Needed
With all eyes in Washington focused on budget details, pressure is mounting again to shorten the data exclusivity for innovator biologics so biosimilars can hit the market sooner.
In letters to House and Senate leadership, the Generics Pharmaceutical Association (GPhA) urged Congress to reduce data exclusivity from 12 years to seven years and prohibit "evergreening" of that exclusivity when sponsors make minor changes to the biologic.
Such actions would produce $4 billion in savings to federal health programs over a 10-year period, according to the trade group.
Whether that savings would materialize depends on when biosimilars are approved and how they're received. While data exclusivity and patent protection have expired for several blockbuster biologics, sponsors have yet to submit an application to the FDA for a biosimilar approval. And according to the latest BioWorld Data report, The Biosimilars Game: A Scorecard for Opportunities, Threats and Critical Strategies, market adoption continues to be an issue in some countries where biosimilars have been approved.
Editor's note: For a copy of BioWorld's new biosimilars report, please contact the BioWorld Data account managers for exclusive introductory pricing at (800) 477-6307. n
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