The FDA’s Patient Focused Drug Development Initiative highlights the power and value of patient advocacy groups in the US

FDA Patient Focused Drug Development Initiative

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The FDA’s Patient Focused  Drug Development Initiative highlights the power and value of patient advocacy groups in the US

The purpose of this new FDA Patient Focused Drug Development Initiative (PFDD) is to fulfill the pledges under the Prescription Drug User Free Act (PDUFA V.) PDUFA V, signed to law in July 2012, gives patients with a disease the chance to have a direct stake in the drug review process, and they can contribute their experiences and views to drug development.

Legislation Prescription Drug User Free Act (PDUFA V)
 Signed into law  July 2012
 Duration  5 years (2013-2017)
 Reach  At least 20 diseases
 Method  Patient perspectives obtained through public meetings
 Upcoming PFDD meetings  Haemophilia, Idiopathic Pulmonary Fibrosis

Dr.Theresa Mullin, Associate Director for Planning and Informatics at the FDA, has said that the “FDA will convene meetings with participation from review divisions, the relevant patient advocacy community, and other interested parties.”

The FDA will convene meetings with participation from review divisions, the relevant patient advocacy community and other interested partiesDr.Theresa Mullin, Associate Director for Planning and Informatics

The FDA will hold at least 4 public workshops per year, with a total of twenty meetings over 5 years.  Each meeting is intended to focus on a different disease area, reviewing the armamentarium for that indication, and identifying areas of unmet need.

Meetings that have taken place in 2014 have covered Sickle cell disease, Fibromyalgia, Pulmonary Arterial Hypertension and Neurological manifestations of inborn errors of metabolism. With more meetings scheduled in 2015, covering a diverse array of diseases such as Breast Cancer, Chronic Chagas, Parkinson’s disease and more, the PFDD has high hopes of being a far reaching program.

Read more about the PFDD here: FDA Patient-Focused Drug Development Initiative  

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