Astellas’ commitment to improving patient lives was exemplified at the 20th Patient-Focused Drug Development initiative meeting hosted by the U.S. Food and Drug Administration (FDA) on September 29, 2016, which focused on organ transplantation.
Held over the course of three years, from 2013 to 2015, each of the 20 meetings centered on a different disease area and were required for the fifth authorization of the Prescription Drug User Fee Act (PDUFA V) as part of the regulatory agency’s new initiative to gather patient perspectives on their condition, its impact on daily life and treatment approaches.
The aim has been to develop a greater understanding of disease severity and to identify the state of the current treatment armamentarium, providing the FDA with the opportunity to hear directly from patients and caregivers about their experiences with specific conditions and their treatments.
Patients or patient representatives actively participated in the meeting, either in person or through a live webcast. Others in attendance included representatives from FDA, other federal agencies, industry, healthcare professionals and patient organizations.
As a spokeswoman for the FDA told Change Together: “There has been an increasing recognition of the critical role that patients can play in informing the understanding of the therapeutic context of benefit risk assessment and informing the clinical development programs for new drugs. The FDA has significantly increased its focus on engaging patients to gain their perspective and insights, as have other parties including patient advocacy organizations, industry sponsors and researchers.”
One of the attendees was Astellas’ head of regulatory affairs and clinical and research quality assurance, Bill Fitzsimmons, who shared the many ways in which the pharmaceutical industry is committed to improving the lives of patients taken complex treatment regimens.
“We are dedicated to improving treatment regimens and drug delivery options for people living with debilitating diseases,” said Fitzsimmons, pointing to the development of sustained-release oral therapies, melting and chewable tablets for those who have difficulty swallowing pills, long-acting injectables and fixed-dose combination drugs. ”We’ve made significant advancements in options that make it easier to take medication, which can improve therapeutic outcomes for patients and help achieve a better quality of life.”
PDUFA V is critical for ensuring the FDA has necessary resources to meet performance goals for the regulatory review of new medicines, speeding up the process to bring innovative new therapies to patients. Now, with the completion of all 20 “Voice of the Patient” meetings, the FDA can now focus on the sixth instalment of the PDUFA which will need to go into effect in September 2017 when PDUFA V’s legislative authority expires.
The FDA issued its Proposed Commitment Letter on July 15 of this year in a public meeting.