August 1, 2014 (Vol. 34, No. 14)

Much to “Like” in Draft Guidance on Misinformation, But Not on Limited-Space Forums

Despite all the hype about its transforming business relationships, half of the top 50 pharmaceutical companies make no use of social media, according to an IMS report released in January. The report showed only one pharma using social media effectively—Johnson & Johnson, whose score of “70” was almost three times that of the next highest-scoring pharma (25 for GlaxoSmithKline).

That percentage of nonusers should be expected to decrease now that big pharmas—not to mention biotechs and medical device companies—have some detailed advice for how to use social media in two key instances. In a pair of draft guidances issued June 17, the FDA offered overdue parameters for what is acceptable speech, and what isn’t, on social media outlets.

One guidance makes recommendations on presenting risk-and-benefit information for drugs or devices using social media that rely on character-limited messages, such as Twitter and paid search result links on Google or Yahoo. The other guidance focused on recommendations for companies attempting to counter misinformation spread by critics or other users on third-party sites.

The sheer volume and speed of social media commentary, plus the additional challenge on some forums of limited character space, pose formidable challenges for biopharmas that the draft guidances partially address.

“Companies are looking for some guidance from the agency on how to deal with that. Certainly, these draft guidance documents are an important first step in that direction,” Glenn M. Engelmann, a senior counsel with the law firm McDermott Will & Emery based at its Washington, DC, office, told GEN.

“I suspect you’ll see companies being more engaged in social media than they have in the past,” said Engelmann, who is vice chair of the law firm’s Life Sciences Industry Group and a former member of AstraZeneca’s executive leadership team responsible for managing the U.S. business.“Until now, companies have held back in terms of correcting misinformation because they were not confident as to how FDA would treat their involvement.” He added that the guidances won’t make companies more or less likely to escalate social-media disputes with critics into lawsuits. 

Risk-Benefit Analysis

Two industry groups representing U.S. biopharmas said they are evaluating the guidances and reviewing them with members, in advance of comments to be submitted later this year to the website FDA has set a 90-day period for feedback that ends September 16.

“We are encouraged that FDA is proceeding with providing us with much needed guidance in this area,” Tracy Cooley, a spokeswoman for the Biotechnology Industry Organization (BIO), told GEN.

Jeffrey K. Francer, vp and senior counsel with Pharmaceutical Research and Manufacturers of America (PhRMA), told GEN that his group had yet to fully vet the draft guidances with members, but did say the draft guidance for limited-character media was especially helpful.

“It’s been very challenging for companies to use Twitter in a way that the FDA prescribes, because the FDA wants to see both benefit and risk information everywhere, not just after the link,” Francer said.

Francer said PhRMA has proposed in the past that companies be allowed to use graphic symbols to indicate risk, with a short statement about what the drug does, and a link to more detailed risk-benefit information.

Such character-limited messages would be along the lines of the FDA’s Twitter tweets every time the agency approves a new drug, which include links with the details about risks and benefits rather than embedding info within the tweets.

“The companies want to provide information that’s useful to physicians and that’s useful to patients, and they should be able to use all the different media that the government uses itself,” Francer said. “I assume that the FDA believes that its own tweets are truthful and not misleading. If they believe that, then why couldn’t a company use Twitter in the same way that the FDA is using Twitter?”

“It actually raises, I think, important First Ammendment issues,” Francer contended. PhRMA also cited free-speech concerns with a January draft guidance in which FDA advised companies on regulatory requirements for post-marketing submissions for prescription human and animal drugs and biologics to “interactive promotional media”—not only social media but blogs and podcasts. Addressing the agency, PhRMA said that draft guidance “could chill truthful and nonmisleading communication protected by the First Amendment” by assuming that all manufacturer statements about prescription medicines on social media constituted promotional labeling or advertising.

Winning and Losing

The latest draft guidances give drug developers both a serious logistical hurdle in limited-space communication, and some needed help for companies faced with untrue criticism on social media that allow for more than 140-character responses.

Unfortunately for biopharmas, the limited-character draft guidance insists on conveying equally a drug’s risk and benefit information within a single tweet, as well as a link to complete information. That may work for some drugs with relatively few risks, but for others, the draft may serve to discourage Twitter communication altogether, or reduce it to a drug name and indication.

The agency should instead consider allowing biopharmas to communicate risks and benefits through separate but simultaneous tweets. Another idea might be to allow tweets conveying drug benefits as responses to critical tweets conveying only risks.

Companies receive a fairer shake from FDA in the draft guidance focused on correcting misinformation. Here, the FDA sets helpful standards:

  • Offer “appropriate corrective information” that is relevant, responsive, limited, and tailored to the misinformation, as well as accurate and nonpromotional, yet consistent with FDA labeling and supported by evidence.
  • Corrective information should either be posted in response to a post containing information, or presented to an administrator for posting as a response, by persons who disclose their affiliation with the company involved.
  • A company should pinpoint what information it is correcting, and where—the portion of a social media forum, such as a thread on Facebook, for example. (Companies, however, are not expected to correct all misinformation throughout a forum.)
  • When companies correct misinformation, they may respond directly on the forum or request that the authors remove their misinformation or allow comments in response.

“Regardless of the Internet source used to communicate about medical products, the public health is best served by clear, accurate, truthful and nonmisleading information about them,” Thomas Abrams, director of the FDA’s Office of Prescription Drug Promotion, wrote on the agency’s blog.

The FDA should keep an open mind as biopharmas weigh in on social media, and companies should develop their own policies. Writing in Social Media Examiner on July 1, Johns Hopkins University professor and researcher Keith Quesenberry offered eight tips to companies that included sharing personal stories, saying “thank you,” personalizing responses, and probably the toughest of them all, owning up to mistakes. All of which, combined with the guidances, should enable biopharmas to effectively get social with physicians and, especially, customers.

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