The RAPS website recently experienced issues that we continue to monitor.  Certain areas of the site including news may be limited.  We apologize for any inconvenience.

Regulatory Focus™ > News Articles > FDA to Discuss Autism and Available Treatments in May

FDA to Discuss Autism and Available Treatments in May

Posted 03 March 2017 | By Zachary Brennan 

FDA to Discuss Autism and Available Treatments in May

An upcoming public meeting is intended to allow the US Food and Drug Administration (FDA) to obtain patient perspectives on the impact of autism on daily life, as well as views on treatment approaches.


As part of commitments tied to the fifth reauthorization of the Prescription Drug User Fee Act (PDUFA V), under Title I of the Food and Drug Administration Safety and Innovation Act, FDA has selected autism as the focus of a public meeting on 4 May 2017, from 1 p.m. to 5 p.m.

The meeting is part of a broader initiative to gain a better understanding of patient and caregiver perspectives on the severity of at least 20 diseases and the available treatments.


“FDA will obtain input of patients and patient representatives on the symptoms of autism that matter most to patients and on current approaches to treating autism. Autism is a neurodevelopmental disorder characterized in varying degrees by difficulties with social interaction, verbal and non-verbal communication challenges, and repetitive behavior patterns,” FDA said, noting that it has approved products for irritability related to autism, including Risperdal (risperidone) and Abilify (aripiprazole).

The agency says it is interested in the perspectives of patients with autism and caregivers on “1) symptoms and the daily impacts of their condition, 2) current approaches to treatment, and 3) decision factors taken into account when selecting a treatment.”

Particular questions that will be asked of patients and patient representatives at the meeting are listed in Friday’s Federal Register notice.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.