Pharmacy organizations support provisions in FDA agreement that would promote use of real-world evidence
APhA and coalition partners sign joint response praising RWE consideration in PDUFA regulatory decisions
Congress won’t reauthorize the Prescription Drug User Fee Act (PDUFA) until 2017, but APhA and other pharmacy organizations expressed satisfaction with FDA-proposed provisions that would enhance the use of real-world evidence (RWE) in decisions that affect the content of guidances on key pharmaceutical issues—in this case, the process for prescription drug approval and postmarket evaluation. PDUFA authorizes FDA to collect fees from biopharmaceutical companies to subsidize the agency’s process for reviewing new drugs and biologics. The agreement’s current incarnation, PDUFA V, expires in September 2017; the sixth installment will be in effect from 2018 through 2022.
The organizations—APhA, the Academy of Managed Care Pharmacists, the American Association of Colleges of Pharmacy, the American College of Clinical Pharmacy, the American Society of Consulting Pharmacists, the American Society of Health-System Pharmacists, the International Academy of Compounding Pharmacists, the National Alliance of State Pharmacy Associations, and the National Community Pharmacists Association—voiced the sentiment in joint comments submitted to FDA following an August 15 public meeting on its July 19 PDUFA performance goals letter.
“Our organizations urge the FDA to include pharmacists as a key stakeholder during this process because pharmacists are pharmacoeconomic experts and have been collecting, analyzing, and using RWE in their practice settings for many years,” the joint comments state.
In addition to encouragement for the consideration of the RWE that pharmacists can provide, the joint response also highlights the organizations’ support for the aspects of the FDA letter—which lays out its intentions for the next version of PDUFA—that would incorporate the patient’s voice in drug development and decision-making, because “pharmacists are easily accessible to patients and collect patient-reported outcomes (PRO) data through the provision of pharmacy services such as medication therapy management, disease management, and patient counseling.”
The other provision commended by the joint comments advances postmarketing drug safety evaluation through expansion of the Sentinel System into FDA pharmacovigilance activities. “The Sentinel program plays a critical role in providing proactive surveillance through a distributed data approach that cannot be replaced by the Adverse Event Reporting System (AERS), Risk Evaluation and Mitigation Evaluation Strategies (REMS), or other surveillance systems that retroactively collect data.”
“In summary, our organizations share a commitment to patient safety and quality patient care, and as such, we commend the FDA for its work on the reauthorization of PDUFA,” the organizations wrote. “We encourage the FDA to use our organizations as a resource as it continues this work.”