The FDA Wants Input From Families Living With Autism

By Lisa Ackerman

The Food and Drug Administration (FDA) wants to hear from families regarding input on autism treatments (1.) There are just over 600 references on the FDA website related to autism. For a lot of families you may be wondering what the FDA has done in regards to autism.  Here are two of their key accomplishments:

• Approved risperidone and aripiprazole as treatments for the symptoms for autism (1)
• In April 2014, the FDA warned parents of possible issues with other treatments (2)

After those two items, not much else about autism can be found on the FDA website. The FDA has a very specific call to action to gain insight on disease symptoms and the daily impact that matters to families in two categories. Here is what the FDA is asking for from their website (3):

Topic 1: Disease symptoms and daily impacts that matter most to patients

1. Of all the symptoms that you/your child experiences because of the condition, which 1-3 symptoms have the most significant impact on your/your child’s life? (Examples may include behavioral symptoms, difficulty with motor coordination, difficulty sleep, difficulty concentrating, seizures, etc.
2. Are there specific activities that are important to you/your child but that you/your child cannot do at all or as fully as you would like because of these symptoms? (Examples of activities may include sleeping through the night, daily hygiene, eating, dressing, participation in sports or social activities, etc.
   1. How do these symptoms and their negative impacts affect daily life on the best days? On the worst days?
3. How has your/your child’s condition and its symptoms changed over time?
4. What worries you/your child most about your/your child’s condition?

Topic 2: Patients’ perspectives on current approaches to treating

1. What are you/your child currently doing to help treat the condition and its symptoms? (Examples may include prescription medications, over-the-counter products, and other therapies including non-drug therapies such as behavioral interventions.)
   1. How has your/your child’s treatment regimen changed over time, and why?
2. How well does your/your child’s current treatment regimen treat the most significant symptoms of the condition?
   1. How well do your/your child’s treatments address specific activities that are important to you/your child’s daily life?
   2. How well have these treatments worked for you/your child as the condition has changed over time? Which symptoms are not addressed as well?
3. What are the most significant downsides to your/your child’s current treatments, and how do they affect your daily life? (Examples of downsides may include bothersome side effects, interacts with other medications, time devoted to treatment, etc.)
4. What specific things would you look for in an ideal treatment for your/your child’s condition?
   1. What would you consider to be a meaningful improvement (for example symptom improvements or function improvements) in your/your child’s condition that a treatment could provide?
5. What factors do you/your child take into account when making decisions about selecting a course of treatment?
   1. What in formation on potential benefits of these treatments factors most into your/your child’s decision?
   2. How do you/your child weigh the potential benefits of these treatments versus the common side effects of the treatments? (Common side effects could include headache, nausea, fatigue, weight gain, etc.)
   3. How do you/your child weigh potential benefits of these treatments versus the less common but serious risks associated with the treatments? (Examples of less common but serious risks are infection, organ damage or failure, suicidal thoughts.)

TACA encourages parents to include in their stories the following:

• Your child’s health status: we know from recent studies children with autism suffer from a myriad of health concerns and comorbid features (4.) Please highlight these concerns in your response.
• Your thoughts: has the FDA reacted quickly and effectively to the autism epidemic (5.)

Parents can submit their answers (6) online:

https://www.regulations.gov/comment?D=FDA-2017-N-0136-0001   It is important to note:  online submissions are due July 5, 2017 at 11:59pm EST.

Here is what we do know: the annual cost of autism is staggering at $268 billion at year with a projected increase of a trillion dollars by 2025 (7.) One can hope the FDA is taking a look at being a change agent to help families and individuals living with autism based on this survey. Family input on this survey, their family needs and how autism effects their loved one is imperative.  It is up to parents to let them know their concerns and provide feedback at this critical time.

References:

1) https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020272Orig1s036,s041,020588Orig1s024,s028,s029,21444Orig1s008,s015.pdf

2) https://www.federalregister.gov/documents/2017/03/06/2017-04229/public-meeting-on-patient-focused-drug-development-for-autism-request-for-comments

3) https://www.fda.gov/downloads/ForConsumers/ConsumerUpdates/UCM394800.pdf

https://www.federalregister.gov/documents/2017/03/06/2017-04229/public-meeting-on-patient-focused-drug-development-for-autism-request-for-comments

4) http://health.usnews.com/health-news/news/articles/2012/09/25/many-children-with-autism-have-other-health-problems-study-says

 5) http://www.tacanow.org/blog/what-constitutes-an-emergency/

6) https://www.federalregister.gov/documents/2017/03/06/2017-04229/public-meeting-on-patient-focused-drug-development-for-autism-request-for-comments

7) https://www.tacanow.org/about-autism/the-cost-of-autism/