The FDA’s Office of Prescription Drug Promotion (OPDP) released its performance metrics for fiscal year 2022 on Oct. 25.

OPDP completed 89 percent of its core launch reviews within 45 days in FY 2022. The agency completed 98 percent of core launch reviews in 45 days in FY 2021 and 95 percent in FY2020.

OPDP noted that “some recent draft core launch promotional materials submitted for voluntary review have raised complex issues that required additional review, resulting in review times that exceeded the 45-day goal. While review timeframes for certain submissions may require more than 45 days in the immediate future, the FDA is working hard to review the majority of submissions within 45 days and to achieve overall completion percentages that are similar to those observed in the past. Sponsors are encouraged to contact the FDA with any questions and to temporarily build in additional review time for their materials.”

OPDP also added that “because this is a program measure (i.e., a measure that focuses on the OPDP program area), the time required for consultation outside of OPDP (if any) on launch campaigns is being subtracted out of the overall review time. As a result, the measure is reflective of the time it takes to review these materials within OPDP rather than the total agency review time.”

OPDP completed 39 core launch reviews in 45 days in FY 2022. By comparison, OPDP completed 41 in FY 2021 and 75 in FY 2020.

OPDP also received 106 complaints regarding potentially false or misleading promotion from health care professionals, consumers, drug sponsors, and law firms in FY 2022. OPDP acknowledged receipt of 99 percent complaints within 30 calendar days. By comparison, OPDP acknowledged all 133 complaints received in FY 2021 within 30 calendar days and of the 98 complaints OPDP received in FY 2020, 98 percent were acknowledged within 30 days.

In addition, the number of Form 2253 submissions and materials continues to increase.

In FY 2021, OPDP received 69,310 submissions of promotional materials, which was slightly more than the 68,709 submissions in FY 2020. Of those submitted in FY 2021, 47,103 were for health care professionals and 22,207 were for consumers. In FY 2020 there were 45,623 submissions for HCP promotion and 23,086 for consumers.

In those 69,310 submissions in FY 2021 there were 145,571 materials of which 98,822 were for HCPs and 46,749 for consumers. In FY 2020 there were 131,944 materials submitted; of these  88,985 were for HCPs and 42,959 were for consumers.

OPDP did not provide the Form 2253 submission and material numbers for FY 2022.

Source: FDA

Source: FDA