CHADD Responds to FDA Request for Comments on ADHD Medications

The US Food and Drug Administration recently asked for comments on making stimulant medications more difficult to abuse and how those changes could affect the millions of people who include medication in their ADHD treatment plans.

The Federal Register notice states that stimulant medications can be open to abuse but that reformulating them can potentially reduce that risk. It also states that reformulations to opioid-based medications have helped to reduce the risk of abuse for some of those medications. It further states the FDA is aware that stimulant medications are not abused as frequently as opioid-based medications have been in recent years.

CHADD’s public policy committee, with input from the professional advisory board, has responded to the FDA’s request for comments. The committee sees a benefit in making stimulant medications harder to abuse but is concerned that these steps could make it more difficult for people to obtain their prescribed medications and could increase the level of stigma surrounding ADHD.

“We recognize that central nervous system stimulants are susceptible to abuse, particularly by those who are using them for nonmedical purposes,” the public policy committee writes in its response to the FDA’s request for comments. “CHADD is part of the Coalition to Prevent ADHD Medication Misuse (CPAMM), a diverse group of organizations working to help prevent the misuse, abuse, and diversion of prescription stimulant medication. More broadly, CHADD is committed to being part of solutions aimed at reducing the misuse of ADHD medications.

“Given their susceptibility to abuse, CHADD is interested in the prospect that abuse-deterrent formulations could have public health benefits and, if done correctly, could even have direct benefits for those prescribed central nervous system stimulants to treat ADHD. We also have serious reservations, however, about potentially negative consequences of abuse-deterrent formulations on individuals and families dealing with ADHD, especially as it pertains to reducing access to ADHD medications, making them more expensive, further stigmatizing the disorder, and other unintended consequences.”

The public policy committee points out that ADHD stimulant medications have been both directly and inadvertently targeted in legislation on state and local levels meant to curb opioid prescription medication abuse.

Research has shown that when stimulant medication is abused, while absolutely a serious concern, it results in far fewer deaths as compared to opioid abuse. Most people who abuse or divert stimulant medication do so to stay awake or enhance academic or workplace performance, rather than attempting to get high from the medication.

“Lumping central nervous system stimulants in with policies designed to thwart opioid abuse is having far-reaching implications that CHADD worries are further stigmatizing ADHD, reducing medication adherence, or even deterring diagnoses, and ultimately leading to more untreated ADHD,” the public policy committee writes. “The costs and challenges associated with untreated or undertreated ADHD are substantial. It is imperative that any FDA actions to invite and approve abuse-deterrent formulations of prescription stimulants not exacerbate current coverage and access hardships.”

The public policy committee appreciates the FDA’s efforts to explore whether it could do more to address the misuse and diversion of stimulant medications. CHADD has worked for many years to make people aware of the risks of misuse and diversion and welcomes steps to reduce diversion of medication.

“The pursuit of abuse-deterrent formulations of central nervous system stimulants holds potential to reduce misuse, abuse, and diversion,” the committee writes. “We therefore ask that FDA take an iterative approach to exploring the possibilities for these formulations. The agency should carefully consider all comments it receives, and pursue direct engagement with stakeholders, prior to issuing any formal policies. CHADD would welcome the opportunity to be part of any discourse or to help convene experts on the topic.”