National Center for Health Research, November 19, 2019
National Center for Health Research’s Public Comments on The Food and Drug Administration Solicits Input on Potential Role for Abuse-Deterrent Formulations of Central Nervous System Stimulants; Establishment of a Public Docket; Request for Comments
The National Center for Health Research (NCHR) is a nonprofit think tank that conducts, analyzes, and scrutinizes research, policies, and programs on a range of issues related to health and safety. We do not accept funding from companies that make products that are the subject of our work.
Prescription stimulants are frequently abused or misused, particularly by people for whom the drugs were not prescribed. It is unclear how changing the formulation would reduce the likelihood that a drug will be abused or misused, but if that can be proven, that could be an important option. However, the label “abuse deterrent” is too often misunderstood. When considering a new category of stimulants, it is essential to avoid the misunderstandings that arose when certain opioids have been labeled “abuse deterrent.”
Research shows that opioids labeled “abuse deterrent” were frequently misinterpreted to mean “less addictive.” For example, a 2016 study found that 46% of physicians thought that abuse-deterrent formulations make these medications less addictive than other formulations. Whether the drug is an opioid, stimulant, or any other product likely to be misused or abused, if the drug is formulated to reduce these risks, the wording on labels should explicitly describe any abuse-deterrent claims. For example, if a pill is difficult to crush, it should be labeled “crush-resistant,” not “abuse deterrent.” It is important to use precise language because “abuse” and “addiction” are often used interchangeably.
Additionally, like opioids, these deterrent properties should be tested in the real world using the types of patients and consumers included in the indication to verify that the drug works as intended. The risks and benefits of both short-term and long-term use should be clearly established before approval, including the risk of misuse or abuse.
In summary, if the FDA decides to approve formulations that have some safeguards to reduce abuse or misuse, the label and description should clearly describe the exact property that has been demonstrated in studies of patients and consumers. A label of “abuse-deterrent” is unacceptable because it will be misunderstood. The label should instead say “crush-resistant” or explicitly describe what properties could make the stimulant less likely to be misused or abused.
NCHR can be reached through Stephanie Fox-Rawlings, PhD, at firstname.lastname@example.org or at (202) 223-4000.
- Hwang CS, Turner LW, Kruszewski SP, et al. Primary Care Physicians’ Knowledge and Attitudes Regarding Prescription Opioid Abuse and Diversion. The Clinical Journal of Pain. 2016;32(4):279-284. https://www.ncbi.nlm.nih.gov/pubmed/26102320