Demand Forecasting for Controlled Substances
Hybrid Public Meeting
Rooftop Meeting Space | 1333 New Hampshire Ave. NW | Washington, DC 200036
August 27, 2025 | 2-5pm (eastern)
On August 27, 2025, the Reagan-Udall Foundation for the FDA, in collaboration with the Food and Drug Administration (FDA), will host a hybrid public workshop on "Demand Forecasting for Controlled Substances.” This workshop will include exploration of the complex factors that are considered when estimating the medical, scientific, and reserve stock needs for Schedule I and Schedule II substances, such as opioids and stimulants. Speakers will include representatives from government agencies, the private sector, and academic researchers.
The public — including consumers/patients, health care providers, researchers, and manufacturers — are invited to provide brief public comments (maximum 5 minutes) on key topics regarding quota modeling such as:
- Methods and processes used in forecasting demand and considerations for the unique circumstances of estimating demand for controlled substances
- The effects of misuse/diversion on controlled substances and how they should be considered in demand forecasting
- Potential impacts of underestimation or overestimation of demand on patients who are prescribed Schedule II substances
The deadline to request to present public comment is Wednesday, August 13, 2025. Comments can be made by in-person and virtual attendees.
Background on the role of federal agencies in demand forecasting:
Each year, FDA submits an estimate of medical, scientific, and reserve stock needs for Schedule I and II substances to the Drug Enforcement Administration (DEA). In turn, DEA uses these estimates, along with data from other sources, to set an overall quota or limit for these substances, as well as individual quotas for manufacturers of these substances.