ADHD Advisory Committee Wants FDA-Defined Standards Before Clearing Abuse-Deterrent Stimulant Label

Panel on Arbor Pharmaceuticals' reformulated stimulant highlights the risks of trying to craft a new labeling niche without any FDA guidance or endorsement of the idea.

Washington, USA- January13, 2020: FDA Sign outside their headquarters in Washington. The Food and Drug Administration (FDA or USFDA) is a federal agency of the USA. — FDA needs clearer standards for abuse-deterrent stimulants, its advisors say • Source: Shutterstock

Arbor Pharmaceuticals, LLC's failure to get the support of two US Food and Drug Administration advisory committees for its reformulated stimulant designed to deter abuse shows the challenges that come with being the first sponsor to try to obtain a new labeling claim, particularly a claim for which FDA has no defined standard or bar a company can shoot for.

The Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory committee voted unanimously 8 October that the benefits...