With the current authorizations of the Medical Device User Fee Act (MDUFA) and Prescription Drug User Fee Act (PDUFA) set to expire in 2017, the U.S. Food and Drug Administration (FDA) held two meetings this week to begin the reauthorization process for the laws. During both meetings, ACC members stressed the importance of efforts focused on bringing safe and effective drugs and devices to patients, and encouraged the FDA to leverage medical specialty societies to explore new ways to accomplish the common goal.

On July 15, Richard J. Kovacs, MD, FACC, provided cardiology's perspective on PDUFA, legislation that allows the FDA to collect user fees in order to fund the drug review process. According to the FDA, "PDUFA's intent is to provide additional revenues so that FDA can hire more staff, improve systems, and establish a better managed human drug review process to make important therapies available to patients sooner without compromising review quality or FDA's high standards for safety, efficacy, and quality."

Kovacs shared how the cardiovascular therapy landscape has advanced significantly since PDUFA was enacted in 1997. During this time period, there has been a more than 30 percent reduction in death from cardiovascular disease, an increase in patients over the age of 65, new options for the reduction of stroke risk in patients with atrial fibrillation, new treatments for the expanding population of patients with heart failure, and new cholesterol lowering drugs for the 73 million Americans in need of risk reduction.

Kovacs also highlighted how novel surveillance methods such as clinical data registries enable the collection of continuous and consecutive patient data, granular clinical data needed for risk-adjustment, patient reported outcomes, and detailed and relevant clinical outcomes.

According to Kovacs, the FDA should increase funding for regulatory science activities; increase use of novel techniques for postmarket surveillance and patient-centric data generation; develop regulations and guidance to address issues pertaining to use of existing data sets for FDA activities (data transparency); and leverage the knowledge and expertise of medical specialty societies.

"Cardiovascular patients have benefited greatly from PDUFA and the commitments made by the FDA and industry to provide a more stable, transparent and predictable pathway for prescription drugs, but there is still room for improvements," said Kovacs. "As negotiations commence for PDUFA VI, we urge industry and the FDA to consider the potential for the use of observational data, such as those residing in clinical data registries, in improving the drug development process."

Earlier in the week, Frederic S. Resnic, MD, MSc, FACC, weighed in on the reauthorization of MDUFA, legislation that aims to accelerate US access to effective and safe novel medical devices to improve patient outcomes. According to the FDA, "Medical device user fees and increased appropriations are essential to support high-quality, timely medical device reviews, and other activities critical to the device review program."

Resnic pointed to the STS/ACC TVT Registry™ as an example of an innovative collaboration among stakeholders to address concerns regarding access to new technology. Stressing that MDUFA IV funds must support postmarket surveillance, Resnic recommended that the FDA implement 2015 Planning Board recommendations; develop and sustain device registries where appropriate; identify and increase use of novel techniques for postmarket surveillance; and draft and implement regulations and guidance to address issues pertaining to use of existing data sets for FDA activities.

Stay tuned for developments regarding the reauthorization of the User Fee Acts.

Keywords: Atrial Fibrillation, Cardiology, Cholesterol, Financial Management, Heart Failure, Industry, Patient Outcome Assessment, Prescription Drugs, Registries, Risk Reduction Behavior, Societies, Medical, Stroke, United States Food and Drug Administration

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