The Commission endorses former FDA head Gottlieb’s call for drug approval processes to encompass considerations beyond the clinical effect of a drug on the individual to whom it is prescribed. We also recommended broadening Gottlieb’s proposal in two ways. First, intentional and unintentional diversion risk should be considered when national regulatory agencies contemplate approval of all substances with addictive liability (e.g., stimulants, benzodiazepines) not just opioids. Second, such agencies should weigh how introducing a new drug could have interplay not only with approved medicines, but also with drugs available in illegal markets. Regulatory agencies should be provided added funding to conduct such assessments, which will require them to research illicit drug markets and to employ staff with the relevant expertise to analyze the data.
In calling for greater consideration of the aforementioned risks that extend beyond the patient, the Commission does not suggest that they be the only consideration in drug approval. A desperately needed medicine could still be approved even if it had significant diversion risk. In such cases, regulators might advise that its use be limited to within health care facilities. Cocaine is an FDA-approved Schedule II drug with almost no diversion because it is used for surgery and administered by the clinician at a medical site, such as a hospital. Likewise, Germany has a per capita opioid prescribing rate close to Canada’s, but no evident opioid crisis because only in Canada are opioids frequently provided in prescriptions to ambulatory patients rather than employed mainly in supervised settings. Policymakers thus have options between approving unrestricted use and denying approval in cases where a medication has unique therapeutic value but also poses risk.