R Street Institute has submitted comments to the Reagan-Udall Foundation for the Food and Drug Administration regarding a public meeting on demand forecasting for controlled substances. Stacey McKenna, speaking on behalf of R Street’s Integrated Harm Reduction department, addressed concerns about how federal drug quotas are set and their impact on public health.
The Drug Enforcement Administration (DEA) sets annual production limits for Schedule I and II drugs. While these quotas aim to prevent misuse and diversion, McKenna stated that overestimating diversion risks can result in medication shortages that negatively affect patients. “First of all, prioritizing diversion avoidance over meeting demand can lead agencies to underestimate need. This leads to medication shortages that can harm patients,” McKenna said.
She pointed out that restricting access to opioid painkillers may force healthcare providers to prescribe fewer opioids or increase medication costs for patients. Abruptly reducing or discontinuing prescriptions can cause acute or chronic pain and withdrawal symptoms among those dependent on such medications. According to McKenna, “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.”
McKenna highlighted research indicating that policy changes—such as the DEA’s 2014 decision to move hydrocodone from Schedule III to Schedule II—led some patients who lost access to prescription opioids to seek alternatives in illicit markets. She explained that unregulated substances pose increased overdose risks: “Because illicit market substances are unregulated and highly variable, this dramatically increases risk of overdose and other health complications.”
Methadone was cited as an example where regulatory barriers contribute more significantly to diversion than excessive prescribing. The medication is used both for pain management and treatment of opioid use disorder (OUD), but its availability is limited by strict regulations requiring frequent clinic visits at geographically sparse locations. As a result, people unable to access methadone through legal channels sometimes turn to the illicit market.
“In fact, evidence suggests that most diversion of methadone is attributable not to excessive prescribing but to excessive treatment barriers,” McKenna noted.
McKenna argued that medical professionals—not law enforcement agencies—should be responsible for determining patient needs regarding controlled medications: “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.”
The R Street Institute describes itself as a nonprofit think tank focused on policies balancing free-market principles with pragmatic solutions in support of public health and safety.
