FDA to focus on autism as part of its Patient-Focused Drug Development program

FDAUS – Food and Drug Administration (FDA) released last week a list of conditions that it is planning to assess in the next two years. This will be part of the Patient-Focused Drug Development (PFDD) program.

What the PFDD does is that it asks asks patients about their specific disease or condition, how they  assess their treatment options that are currently available to them,as well as what their ideal treatment would be. Individuals are also asked about the risks that they would be willing to take for more advanced treatments.

The ultimate hope is that these preferences can then be incorporated into the regulatory review process.

So far 15 patient-focused drug development meetings have been held by the FDA.

It was announced on July 1 2015, that the FDA will be adding eight conditions to its PFDD program between Fiscal Years 2016-2017: one of which is autism.

The other 7 conditions include:

  • Alopecia areata
  • Hereditary angioedema
  • Non-tuberculous mycobacterial infections
  • Patients who have received an organ transplant
  • Psoriasis
  • Neuropathic pain associated with peripheral neuropathy
  • Sarcopenia

Source: Alexander Gaffney: RAPS.org website: FDA to Focus on Autism, Psoriasis Under New Patient-Focused Program