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# Patient-Focused Drug Development Praised
- URL: https://www.fdaweb.com/patient-focused-drug-development-praised/
- Published: 2016-01-04T12:00:00.000Z
- Updated: 2026-09-15T02:24:10.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5134284

> CDER Office of Strategic Programs director **Theresa Mullin** says that public meetings held as part of FDA’s Patient-Focused Drug Development (PFDD) program teach the value of regulators simply listening to patients. Writing in an *FDA Voice* blog [post](http://blogs.fda.gov/fdavoice/index.php/2015/12/fda-invites-patient-organizations-to-take-a-place-at-the-podium/?ref=fdaweb.com), Mullin says PFDD was started under PDUFA 5 to more systematically obtain the patient perspective on certain diseases and their treatments.  
>  
> Each public meeting, she writes, is focused on a specific disease area. “Our commitment is to gain perspectives on at least 20 disease areas by the end of FY 2016,” Mullin writes. “And having already held 17 meetings to hear from patients with diseases as varied as breast cancer, fibromyalgia, and sickle cell disease, we are well on our way.”  
>  
> According to Mullin, the agency has heard from patients, their families, and caregivers about the symptoms that matter most to them, the impact the disease has on patients’ daily lives, and their experiences with currently available treatments. She says they have heard that for diseases that are progressive and severely disabling, patients and their families may consider an ideal treatment to be one that at a minimum can halt disease progression.  
>  
> “These perspectives are critical to helping us understand the context in which we are making regulatory decisions for new drugs,” Mullin says. “And they’ll have ramifications for years to come. We believe that the long-term impact of PFDD will be better, more informed FDA decisions and oversight, both during drug development and during our review of a marketing application.”  
>  
> FDA wants to expand the PFDD meeting model, Mullin says, and plans to hold 24 different disease-focused meetings by the end of FY 2017\. It also is inviting the independent efforts of patient organizations to identify and organize externally-led patient-focused collaborations to generate public input on other disease areas. “Given the tremendous number of diseases affecting the U.S. patient population and the effort required to conduct a successful PFDD meeting, externally led PFDD meetings should target disease areas where there is an identified need for patient input on topics related to drug development,” Mullin concludes.