Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, was quoted in an article titled “Social Media Use Presents Challenges for Drug Manufacturers, Experts Say.”
Following is an excerpt:
Navigating social media is challenging for pharmaceutical manufacturers given the current lack of direction from the Food and Drug Administration, experts said Oct. 2 during a Food and Drug Law Institute conference.
While FDA has released one guidance dealing with social media, there is a “relative vacuum of social media regulations,” said Thompson. ?…
The best information comes from FDA enforcement actions, such as warning letters, Thompson said. There were around nine FDA warning letters in 2012 that mentioned Facebook, he said.
Thompson said there are five basic issues for pharmaceutical companies using social media, including:
- What online communications are pharmaceutical manufacturers accountable for?
- How can manufacturers fulfill regulatory requirements in social media?
- What parameters should apply to posting corrective messages on websites controlled by third parties?
- When is the use of links appropriate?
- What are the implications of monitoring and reporting adverse event information about products?