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FDA Proposes Ways to Explain Risks and Benefits in 140 Characters or Less

Katz, Alissa

doi: 10.1097/01.HJ.0000454623.88242.b5


The U.S. Food and Drug Administration (FDA)’s long-awaited draft proposal for how device and prescription drug makers should handle posts on electronic platforms with character limitations, such as social networks like Twitter and sponsored links on Google or Yahoo, has met mixed reviews across the healthcare industry.

While experts agree that guidance on the topic is needed, they've raised the question of whether this particular iteration is too little, too late.

“Unfortunately, when it comes to proposals from the government, that [ambiguity] is more the rule than the exception,” said Robbie Poole, CEO of Obelis Media, a digital marketing company for hearing healthcare.

“I do believe vendors and providers will use Twitter to a lesser degree when it comes to promoting medical devices because of the haze of uncertainty.”

The FDA held a two-day public hearing in November 2009 to gather input on the promotion of FDA-regulated medical products using the Internet or social media. The Agency was required to issue guidance about that topic within two years of the enactment of the Food and Drug Administration Safety and Innovation Act, which was signed by President Barack Obama on July 9, 2012.

The draft guidance document was distributed for public comments, which will be accepted through Sept. 16. Once the draft is finalized, it will represent FDA's current thinking on the topic, but companies are not required to follow the guidance document; it represents recommendations only.

“I think it's important for the public to receive information about the risks and benefits of prescription drugs and medical devices, even on platforms like Twitter, where character limitations may pose significant challenges,” said Ryan McCreery, PhD, associate director of audiology and staff scientist at Boys Town National Research Hospital, and a columnist for The Hearing Journal.

“The only negative I would note is that the guidance seems to have come a bit late given how this type of communication has grown over the past five years.”

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In the draft guidance document, which was published June 18, the FDA suggests that companies carefully consider whether a social media platform or sponsored link is a practical marketing tool for particular products, especially those with complex indications or extensive serious risks.

If a company decides to use such a platform to make a product benefit claim, the benefit information should be accurate and non-misleading, and it should include material facts, such as limitations to an indication or the relevant patient population, according to the proposed recommendations.

Risk information also should be included in the same character-limited communication, along with a mechanism to provide a more complete discussion of the associated risks, like a hyperlink to a dedicated landing page on that topic, the document noted.

In addition, the prominence of the risk information should be comparable to that of the benefit information, and, at a minimum, the most serious risks associated with a product or device should be presented in the communication.

The proposed recommendations were crafted particularly for pharmaceuticals and devices that have higher risks, said Andy Bopp, executive director of the Hearing Industries Association. Hearing aids are low-risk devices, but they are restricted, so the proposal still applies, he added.

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A second draft guidance document from the FDA applies when a company voluntarily decides to correct misinformation about its own product that was created or disseminated by an independent third party on the company's own forum, an independent third-party website, or social media.

“A firm may choose to provide appropriate truthful and non-misleading corrective information, or, alternatively, it may provide a reputable source from which to obtain the correct information, such as the firm's contact information,” the draft says.

To be considered appropriate corrective information, the company's message should be limited and tailored to the misinformation; non-promotional in nature, tone, and presentation; and accurate, according to the proposed recommendations.

The correction also should disclose that the person providing the information is affiliated with the company and include the FDA-required labeling in a readily accessible way, such as a portable document format (PDF) file or a link that goes directly to the labeling and is not promotional.

A company is not expected to correct every piece of misinformation in a particular forum. However, it should not pick and choose only to correct misinformation that portrays its product in a negative light, ignoring misinformation that overstates the benefits of its product, the FDA said in the draft document.

In case of FDA requests to recall corrected information later, a company should keep records on the content of the misinformation, where it appeared, the date it appeared or was located, the corrective information that was provided, and the date the information was corrected.

“As far as guidance about how companies can respond to misinformation posted by others online, the FDA wants a balanced response,” Dr. McCreery said. “This seems sensible, but it also leaves some gray area for the companies as far as what type of response could be considered balanced.

“In practice, I can see misinformation about products that may be difficult to concisely rebut. Manufacturers will have to be cautious in how they attempt to correct misinformation effectively.”

The comment period may help clear up some of the ambiguity surrounding the correction of misinformation online.

“I think there are sensible solutions that will hopefully come from the review process,” Dr. McCreery said.

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