FDA Completes 20 Meetings on Patient Involvement in Drug Development

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The agency’s Patient-Focused Drug Development program completed its commitment ahead of schedule.

FDA’s Patient-Focused Drug Development (PFDD) program, started in response to the Prescription Drug User Fee Act (PDUFA V), held its 20th meeting on Sept. 27, 2016, one year ahead of schedule. The September public meeting involved patients who have received organ transplants.

PFDD was created to “enhance the patient’s voice in drug development.” Under PDUFA V, FDA committed to conducting public meetings in order to gather views from patients in at least 20 disease areas by September 2017. The agency’s Voice of the Patient reports summarize information from patient speaker panels, audience participation, webcasts, and submissions to the public docket. The information is used by FDA employees “when advising sponsors on their drug development programs and when assessing products under review in that disease area.”

“Hearing the patients’ perspectives … helps us understand how patients view the benefits, risks, and burdens of treatments for their condition,” Theresa M. Mullin, PhD, director of FDA’s Office of Strategic Programs in the Center for Drug Evaluation and Research, stated in a FDAVoice blog post.

Industry sponsors and healthcare providers that have also attended the meetings have gained information on the patient’s perspective. Areas of unmet needs have been identified because of the meetings, according to Mullin, and awareness of patient needs has been raised.


FDA plans on an additional four PFDD meetings by the end of fiscal year 2017. The agency is also asking patient groups to share FDA’s efforts by organizing their own meetings. Interested groups can find more information on FDA’s website.

“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. We are extremely grateful to all of the hundreds of patients and their loved ones who have so generously and, in some cases, courageously, participated in our meetings and have shared their personal stories, experiences, and perspectives,” Mullin stated in the blog.

Source: FDA