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Jul 8, 2014

FDA Gets Social with Biopharmas, for Better and Worse

Much to "like" in draft guidance on misinformation, but not on using limited-space forums.

FDA Gets Social with Biopharmas, for Better and Worse

The FDA offered parameters for what is acceptable speech, and what isn’t, on social media outlets in two recent draft guidances. [© arrow - Fotolia.com]

  • 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 Certainly, these draft guidance documents are an important first step in that direction,” Glenn M. Engelmann, a senior counsel with the law firm McDermott Will & Emery based at its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. I suspect given the volume of commentary out there, they will inevitably be selective as to which forums that they participate in,” 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: “What I think it does do is unshackle companies a bit to get more active in a real-time way in social media without fear of running afoul of FDA and incurring any adverse regulatory consequences.”

  • 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 www.regulations.gov. 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, and this can be very challenging,” Francer said. “If the FDA is going to require the same type of fine print that you see in a magazine ad to be in a tweet, then the FDA is essentially taking that tool away from patients who may want to hear from companies as well as healthcare professionals.”

    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 Amendment issues when the government is restricting the speech of a particular party, but kind of engaging in that same exact speech itself,” Francer added.

    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—one devoted to risks, one to benefits—since the extra space would allow for better summaries of both, with each tweet offering a separate link on risks or benefits. 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. After exempting any “communications that are owned, controlled, created, or influenced, or affirmatively adopted or endorsed, by, or on behalf of, the firm,” the draft guidance sets helpful standards for how companies should act:

    • 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.
    • Companies should pinpoint what information it is correcting, and where—the portion of a social media forum, such as a thread on Facebook, for example. The FDA spells out that companies are not expected to correct all misinformation throughout a forum.
    • Companies have a choice in how to correct misinformation: responding directly on the forum, providing corrective information to authors of misinformation, or requesting 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 Office of Prescription Drug Promotion in the FDA’s Center for Drug Evaluation and Research (CDER), wrote on the agency’s blog.

    The FDA should keep an open mind as biopharmas weigh in on social media. Companies should develop their own policies, starting with a decision to not only start using social media, but use it well. 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.

    Do you think the FDA needs to have as strict a stance on social media outlets as it does on traditional communication modes of regulatory information?


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