US FDA To Screen Rx Drug Launch Promos Prior To Initiating Review
Office of Prescription Drug Promotion is adding a five-day screening period to its review of core prescription drug launch materials to determine if they are actually core promotions with all necessary information. Companies can decide whether to resubmit materials deemed non-core or have FDA go forward with a non-core launch review.
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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.
Office of Prescription Drug Promotion issued just six letters citing companies for improper drug promotion in 2020, including the placement of safety information in an email and making unfounded COVID-19 claims. New research projects focus on celebrity endorsements, medical conference materials.
New review process planned to launch next year. FDA officials and industry reps note re-emergence of FDA enforcement actions targeting internet-sponsored links.