(210) Trends in FDA Post-Marketing Commitments and Requirements for Newly Approved Drugs, 2016-2021

Publication Number: 1255

Background: In 2007, the United States Congress passed the Food and Drug Administration Amendments Act (FDAAA), which authorized the FDA to require manufacturers to conduct post-marketing studies as a condition of marketing approval. Post-marketing safety studies are conducted to confirm existing safety data from clinical trials, identify new safety signals, or provide reassurance regarding the safety of approved medications.

Objectives: To describe the study type, population and aims of post-marketing commitments/requirements (PMC/Rs) for products recently approved by the FDA.

Methods: Publicly available data from the FDA Postmarking Requirements and Commitments database were analyzed to identify all new molecular entities (NMEs) approved for adult populations between Jan 1, 2016, and Dec 31, 2021 with PMC/Rs. PMC/Rs were summarized by product type (drug/biologic); purpose (safety/non-safety); study design; and therapeutic area of the indication.

Results: There were 408 products approved by the FDA from 2016 through 2021 with at least one PMC/R, of which 50% (650/1297) included adult populations and 40% (521/1297) included pediatric patients. Among the 650 adult PMC/Rs, 615 (95%) were drugs and 35 (5%) were biologics. 55% (357/650) were focused on safety and 29% (191/650) were observational designs.
Oncology accounted for 43% (281/650), 12% (75/650) infectious disease, endocrinology 4% (25/650), and general medicine 13% (83/650) of adult PMC/Rs. Of the total 650 adult PMC/Rs, there were 57 (9%) in 2016; 102 (16%) in 2017; 136 (21%) in 2018; 110 (17%) in 2019; 160 (24%) in 2020; and 85 (13%) in 2021.
Compared to adult studies, pediatric studies were spread more evenly with respect to both therapeutic area and submission year.

Conclusions: FDA approval of NMEs is frequently accompanied by requirements for additional studies which should be included in lifecycle management strategies.
PMC/Rs with pediatric populations tended to have a more similar number of observations across therapeutic areas and by year than adult populations though the number of adult studies was much higher.
The primary limitation of this project is the variety in specificity of language in PMC/Rs which resulted in several submissions which could not be definitively categorized as either observational or interventional.