October 8, 2020
Thank you for the opportunity to speak today on behalf of the National Center for Health Research. I am Dr. Meg Seymour, a senior fellow at the center. Our center analyzes scientific and medical data to provide objective health information to patients, health professionals, and policy makers. We do not accept funding from drug or medical device companies, so I have no conflicts of interest.
Our center strongly supports research and programs to improve the safety and appropriate use of stimulants. All drugs that the FDA considers for approval should be held to a high standard of safety and effectiveness, but the standard for drugs with a high abuse potential needs to be even higher. We all know that ADHD medications are widely misused, and we share many of the concerns expressed by FDA scientists about this application.
Since there is currently no established pathway for developing abuse deterrent stimulants, the applicant has applied abuse deterrent guidance for prescription opioids. However, the abuse deterrent definition of opioids has been widely criticized, since the term has usually been applied to opioids that are difficult to crush but not so difficult to abuse. If an ADHD drug is merely difficult to smoke or inject, it should be labeled as such, not as abuse deterrent. Abuse deterrent is a misleading term. Research shows that patients, family members, and healthcare providers often misunderstand the meaning, thinking it means “less addictive.”
FDA should not make the mistake of using such a widely misunderstood term again, especially since approval of this stimulant as abuse deterrent will set a precedent for approving future stimulants.
In addition to the problems of the term “abuse deterrent” the research presented does not even demonstrate that AR19 adequately deters intranasal or intravenous nonmedical use or abuse. The sample in the intranasal abuse study is strikingly small – only about 40 patients – which makes any claims of deterrence even more questionable. We agree with the FDA’s scientific assessment that the drug could actually lead to an increase in nonmedical use and abuse, given the high dose per capsule. Even worse, there is no assessment of how to deter oral abuse, which is the most common method for abusing stimulants.
We also share the FDA scientists’ concerns over the risks of nonmedical use via IV. Talc has been shown to be contaminated with asbestos in previous research, and there are also unidentified impurities present in syringeable material. Both of these pose serious health risks for those engaging in IV nonmedical use of the drug. The applicant’s claims of safety do not account for high talc exposures from high exposure to AR19 or to accumulation from continued use.
It is past time for the FDA to retire the term “abuse deterrent” for opioids, and it could be a disaster to start using it for stimulants. We respectfully urge you to listen to the concerns expressed by FDA scientists, who point out that AR19 has no properties to mitigate the most common form of abuse. Instead, the drug should be labeled with an accurate description of its properties, not “abuse deterrent,” so that patients, family members, and healthcare providers do not erroneously assume the drug is less addictive.
The advisory committee unanimously voted that the benefits did not outweigh the potential risks for this drug application.