New Social Media Guidance From US FDA May Be On The Horizon
Future guidances may address information on healthcare sites and individual influencers and endorsers. ‘It is a difficult time to make any predictions about the timing of guidance,’ but the agency is looking at these issues, CDER deputy center director Grail Sipes tells FDLI conference.
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Senators ask the agency to address the “regulatory loophole” permitting telehealth companies to promote prescription drugs without disclosing side effects and question if FDA has enforcement authority over third-party social media influencer promotions.
Office of Prescription Drug Promotion issued six enforcement letters and launched three research projects in 2021. There were more internal changes as the office switched to electronic submissions of promotional materials and went through year-end reorganization.
Grail Sipes, CDER deputy center director for regulatory policy, will move to the Executive Office of the President next month.