Demand Forecasting for Controlled Substances

Hybrid Public Meeting
Rooftop Meeting Space | 1333 New Hampshire Ave. NW | Washington, DC 20036
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), hosted a hybrid public meeting on "Demand Forecasting for Controlled Substances.” This meeting includeed 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 included representatives from government agencies, the private sector, and academic researchers.

Members of the public — including consumers/patients, health care providers, researchers, and manufacturers — submitted requests to provide brief comments during the meeting (maximum 5 minutes) on key topics regarding quota modeling such as:

  1. Methods and processes used in forecasting demand and considerations for the unique circumstances of estimating demand for controlled substances
  2. The effects of misuse/diversion on controlled substances and how they should be considered in demand forecasting
  3. Potential impacts of underestimation or overestimation of demand on patients who are prescribed Schedule II substances

Due to the large volume of submitted requests to provide public comment we've received, public comment registration is now closed.

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.

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Agenda

2pm

Welcome

  • Susan C. Winckler, RPh, Esq., CEO, Reagan-Udall Foundation for the FDA

2:05pm

FDA Opening Remarks

  • Lowell Zeta, JD, Deputy Commissioner for Strategic Initiatives and Special Counsel, U.S. Food and Drug Administration

2:10pm

CDER Fireside Chat

  • Marta Sokolowska, PhD, Deputy Center Director for Substance Use and Behavioral Health, Center for Drug Evaluation and Research, U.S. Food and Drug Administration
  • Susan C. Winckler, RPh, Esq.

2:20pm

Overview

  • Amar Bhat, PhD, COO, Reagan-Udall Foundation for the FDA

2:35pm

Public Comment

Each commenter will have 3 minutes to speak.

Topics:

  1. Methods and processes use in forecasting demand and considerations for the unique circumstances of estimating demand for controlled substances
  2. The effects of misuse/diversion on controlled substances and how they should be considered in demand forecasting
  3. Potential impacts of underestimation or overestimation of demand on patients who are prescribed Schedule II substances

4pm

Demand Forecasting Panel

Panelists:

  • Laura Bray, MBA, Chief Change Maker and Founder, Angels for Change
  • John A. Gilbert, JD, Director, Hyman, Phelps & McNamara
  • Nicolette Louissaint, PhD, Chief Policy Officer, Healthcare Distribution Alliance
  • Emily Tucker, PhD, Dean's Assistant Professor, Department of Industrial Engineering, Clemson University
  • Jillanne Schulte Wall, JD, Senior Director of Health and Regulatory Policy, American Society of Health-System Pharmacists

5pm

Adjourn