Eli Lilly Looking For More ‘Clarity' From FDA
by Mark Tosh, Editor-in-Chief, DTC Perspectives

A regulatory executive from Eli Lilly called on the FDA to address online promotion and social media tools either through “guidance or executive channels” so pharma has “the detail and clarity” it needs to effectively use new media. Michele Sharp, a senior director of U.S. regulatory affairs at Eli Lilly, said a pro-active approach by FDA will allow industry to present the most accurate, balanced and timely information to patients in the most relevant places for them to find it.

• “There are still important unanswered questions around Internet promotion, and we believe FDA action on those issues would benefit the public health,” she said on the opening day of the hearing. “And [we also] believe it's important for you to hear from companies like us about what has kept us from more active engagement in social media.”

Before acting to address social media and online promotion, Lilly suggested that FDA consider “the unintended consequences of either, one, providing no further guidance to the pharmaceutical industry – the uncertainty of which keeps industry on the sidelines – or two, imposing too many, or overly confining, restrictions on industry, which could silence an important voice in the chorus.”

In the current environment, Lilly has decided to avoid “significant interaction” via social media with patients and healthcare professionals “largely because of a lack of clarity in understanding FDA's expectations as to how we could participate and comply with FDA requirements.”

Lilly recommend two moves for FDA: leading a series of public workshops to “generate ideas, leverage the knowledge, expertise and experiences of the participants and work toward viable solutions” and to create “ongoing working groups” to help FDA address emerging technologies. In addition, Sharp said Lilly “would appreciate the opportunity to engage in further discussion with the agency and other stakeholders.”

[Click here to view complete transcript of Michele Sharp's statement at the hearing]

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