Reed Smith’s Life Sciences Health Industry Group will be hosting an upcoming CLE webinar, “Hosting and Managing User Generated Content (UGC)” on Thursday, January 19, 2017 at 12 p.m. ET. This webinar will address the legal liability and responsibility of a drug or device company that incorporating any user generated content (UGC) features on websites … Continue Reading
The Reed Smith Life Sciences Health Industry Group will be hosting a free CLE webinar, “Social Media Issues for Pharmaceutical and Medical Device Companies,” on November 2, 2016 at 12 p.m. ET. Social media can be a great way to engage with consumers and build your brand. For pharmaceutical and medical device companies, however, it … Continue Reading
Earlier this week, the FDA issued two draft guidances on social media, and Reed Smith attorneys Colleen Davies, Celeste Letourneau, Kevin Madagan, and Jennifer Pike have written a client alert that analyzes them both in detail. The first guidance pertains to product claims and risk information on platforms like Twitter and sponsored links, and the second to correcting third party misinformation that appears in social media, such as in comments on a Facebook page or website.
A key date to keep in mind is that the deadline for comments is September 16, 2014.… Continue Reading
The social media phenomenon has radically transformed the ways in which commercial businesses promote their services and products. However, as a result, companies must consider potential legal risks from an entirely new angle. To become a successful user of social media, a company must draft, review, disseminate and enforce a social media policy that addresses potential legal issues while at the same time emphasizing positive exposure for the business.… Continue Reading
FDA's Office of Prescription Drug Promotion has warned a Swiss drug company about failing to include risk information and omitting material facts regarding its products. What makes these particular violations noteworthy is that they occurred on the company's Facebook page. FDA became aware of the company's Facebook promotion through its own monitoring and surveillance program.… Continue Reading
FDA has issued draft guidance designed to shed light on how drug companies should comply with FDA's postmarket submission requirements when interactive promotional media constantly changes. In laying out the criteria for how and when to submit interactive promotional media for postmarket review, FDA provides important insight into the type of social media promotion in which it is most interested.… Continue Reading
Following a decade-long hiatus, the Food and Drug Administration ("FDA") appears ready to finally address industry Internet communications. FDA's Center for Drug Evaluation and Research ("CDER") in collaboration with other divisions within FDA, held a two day hearing on November 12th and 13th to help the Agency determine how the statutory provisions, regulations, and policies governing advertising and promotional labeling should be applied to product-related information on the Internet and emerging technologies...… Continue Reading
On November 12 and 13, 2009, the FDA hosted public hearings to vet the potential need for regulation of prescription pharmaceutical and medical device marketing on social media outlets such as YouTube, Wikipedia, Facebook, and Twitter. The FDA specifically sought input on these five questions: (1) For what online communications are manufacturers, packers or distributors accountable? (2) How can manufacturers, packers, or distributors fulfill regulatory requirements in their Internet and social media promotion, particularly when using tools that are associated with space limitations and tools that allow for real-time communications? (3) What parameters should apply to the posting of corrective information on Web sites controlled by third parties? (4) When is the use of links appropriate? and (5) Questions specific to Internet adverse event reporting...… Continue Reading
