Each year, FDA submits an estimate of domestic medical, scientific, and reserve stock needs for Schedule I and II substances, and other requested substances (together known as "quota-relevant substances"), to the DEA. To inform potential improvements in the accuracy of these annual estimates, the Foundation, on behalf of FDA's Center for Drug Evaluation and Research, has conducted a review of data sources and forecasting techniques used by government agencies, the private sector, and academic researchers to predict demand for controlled substances. To conduct this review, the Foundation:
- Carried out a review of current statistical modeling techniques used by the pharmaceutical industry to assess their strengths and weaknesses, and their applicability to the estimation of domestic medical need of controlled substances
- Conducted a series of one-on-one interviews with industry and academic experts
- Held an invitation-only roundtable to discuss current forecasting techniques
- Held a public meeting with a panel of experts and 25 public commenters
This report summarizes the findings from the review.
