OEA Research & Analysis
OEA conducts economic, public health, social science, and operations research as a basis for forecasting trends, needs, and major problems requiring solutions, and provides assistance and consultation in these areas to FDA leadership and operating units.
For Economic Impact Analyses of FDA Regulations, please click here.
Economics Staff Research & Publications
PHSA Research & Publications
What's New:
- Smoking cessation behaviors and motivation to quit
New OEA research, published in Frontiers in Public Health, indicates that variation in smoking cessation behaviors and motivators across the United States may contribute to health disparities. While quit interest was highest in the West, the South exhibited the lowest rates of quit attempts and successful cessation. Significant differences were also noted between age groups. These findings highlight the need for further research into cessation behaviors at more granular levels to inform policies aimed at reducing smoking-related health disparities among populations facing the greatest challenges in cessation. Authorized Generics in The U.S.
Authorized generics are approved brand-name drugs that are sold by brand-name manufacturers or licensees without brands on their labeling. A new study in Health Affairs describes the universe of authorized generic launches during the period 2010–19.In markets with traditional generics, three-fourths of authorized generics launched after the respective generic competition started. In markets where generics were eligible for the 180-day exclusivity, about 70 percent of authorized generics launched before or during the exclusivity period.
These findings suggest that the timing of authorized generic launches is likely strategic and that brand manufacturers generally introduce authorized generics when the threat of generic entry is heightened after the first traditional generic is approved for the authorized generic’s brand-name drug.