R Street Comments on the Reagan-Udall Foundation for the FDA’s Public Meeting on Demand Forecasting for Controlled Substances

August 27, 2025
Susan C. Winckler
Chief Executive Officer
Reagan-Udall Foundation for the Food and Drug Administration
Washington, DC 20036

Re: Public Meeting on Demand Forecasting for Controlled Substances

Dear Meeting Organizers,

Thank you to the Reagan-Udall Foundation for the Food and Drug Administration for taking public comments on the matter of “Demand Forecasting for Controlled Substances.” My name is Stacey McKenna and I am speaking today on behalf of the Integrated Harm Reduction department at the R Street Institute. R Street is a nonprofit, nonpartisan public policy think tank committed to supporting policies that balance “free market, limited government” ideals with pragmatic solutions that prioritize public health and safety. That is why we are interested in this issue.

Every year, the Drug Enforcement Administration (DEA) sets aggregate production quotas to limit the manufacturing of Schedule I and Schedule II drugs.^[1] While the ultimate goal of these quotas may be to reduce the chances of misuse and diversion of the medications, recent years suggest that underestimating demand and overestimating or overweighting diversion has unintended consequences for public health.  

First of all, prioritizing diversion avoidance over meeting demand can lead agencies to underestimate need. This leads to medication shortages that can harm patients.^[2] For example, restricting the availability of opioid painkillers can lead medical providers to prescribe opioids to fewer patients and can drive up medication costs.^[3] Cutting patients off of their opioid painkillers or dramatically and suddenly lowering their dose may cause them to experience unnecessary levels of acute or chronic pain and, if they have developed physical dependence, withdrawal symptoms.^[4]

In response, patients who lose access to medications sometimes turn to the illicit market. For example, research shows that the DEA’s 2014 rescheduling of hydrocodone from Schedule III to the more restrictive Schedule II contributed to a rise in illicit opioid use.^[5] Because illicit market substances are unregulated and highly variable, this dramatically increases risk of overdose and other health complications.^[6] In fact, crackdowns on prescription opioid prescribing were a major driver of the second wave of the U.S. overdose crisis, beginning around 2007.^[7]

Not only is fear of diversion given excessive weight in the quota development process, the causes of diversion are not sufficiently taken into consideration. Opioids again provide a useful example. Methadone is a Schedule II medication used both to treat pain and in the treatment of opioid use disorder (OUD). When used to treat OUD, methadone reduces overdose risk by as much as 80 percent, improves quality of life, and reduces criminal activity.^[8] However, this life-saving medication is restricted to opioid treatment programs that are geographically sparse and often require near-daily clinic visits.^[9] As a result, many people with OUD who want but lack access to methadone, or who are in treatment but miss a dose, find themselves turning to the illicit market to self-medicate. In fact, evidence suggests that most diversion of methadone is attributable not to excessive prescribing but to excessive treatment barriers.^[10] Therefore, using methadone diversion as a justification for reducing its production quotas would be misguided and likely counterproductive.

Despite the federal government’s claimed intent of minimizing medication misuse or diversion, recent decades serve as a cautionary tale against cutting supply due to a misunderstanding or overprioritization of diversion. Evidence tells us over and over again that restricting the supply of valuable and valued medications—whether they help people focus and function or allow them to reduce pain enough to go about their day—can lead people to alternatives. Sometimes, this is a shift to dangerous, unregulated drugs. Sometimes people turn to illegally diverted drugs to self-medicate. In either case, the better solution would be to ensure that health care providers—not law enforcement agencies such as the DEA—are the ones making decisions about their patients’ medical needs.  

Respectfully submitted,
/s/
Stacey McKenna, Ph.D.  
Resident Senior Fellow
R Street Institute
smckenna@rstreet.org