Despite Few Actions On Rx Drug Promos, US FDA Increased Engagement With Stakeholders Last Year

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.

pharma advertising
US FDA objected to five prescription drug promotions in 2021 • Source: Alamy

On the surface, the US Food and Drug Administration’s Office of Prescription Drug Promotion seems to have had a quiet year in 2021 issuing just six enforcement letters and initiating only three research projects. But OPDP was busy behind the scenes as it reviewed more than 130,000 promotional materials, shifted to electronic submissions, and stepped up its communication with stakeholders.

The biggest news was the change in leadership as Catherine Gray became acting and then permanent director in June following the retirement of Tom Abrams in October 2020. Abrams had...

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