FDA Tackling Drug and Device Approvals in a Changing World | Cardiology Magazine

Heart of Health Policy | The future of cardiovascular care regularly finds itself intertwined with the advancement of new technologies and drug treatments. Getting such life-saving devices and medications available to a mass population however, has always been contingent on rigorous U.S. Food and Drug Administration (FDA) approval and regulation processes.

“One of the challenges of device regulation, certainly through the FDA, is the broad array of products that we regulate … from everyday products like Band-Aids and stethoscopes to complex cardiovascular devices such as transcatheter valves, total artificial hearts and atrial defibrillators,” said William H. Maisel, MD, an FDA representative who spoke at ACC.14. “I always return to the vision of what we’re trying to accomplish at the FDA, which is for patients in the U.S. to have access to high-quality, safe and effective devices and hold the gold standard for the rest of the world.”

One of the biggest criticisms of the FDA’s process has to do with time — specifically the lapse that occurs between testing and final approval. According to Maisel, however, the FDA sees 4,000 new submissions for devices every year. Ninety-nine percent of these are moderate risk and take about the same time to market in Europe and other countries. “The lag we’re talking about is in that one percent of important, game-changing devices,” he said.

While opponents of the FDA’s stricter protocols may dispute the need for such prolonged examinations, Maisel noted the prevailing success of transcatheter valve therapy (TVT) and the newly cast doubts on renal denervation as to why being thorough has its merits. In terms of TVT, the ACC and the Society of Thoracic Surgeons have worked with the FDA and the Centers for Medicare and Medicaid Services over the last several years in what is proving to be a successful a new model for effectively and appropriately introducing and tracking new transformational technology and therapies more quickly and with clear recommendations and guidance for use.

Of course there is always room for improvement. “We all need to do better to approve devices that we want our patients to get, and they need to get them sooner,” Maisel said. “As a community we need to discuss at what cost, and by cost I don’t mean dollars and cents, but I mean peer review.”

Ultimately, Maisel sees significant potential in the realm of a global approval enterprise, one that may abandon the current model of multiple approval processes for international coordination. “These products are not used in single jurisdictions,” said Maisel. “With the advent of new device identifiers, modern tools to analyze data and connect registries and disparate data sources, we’re really heading towards a world where we can better harness information from around the globe.”

More locally, the ACC also continues to find new ways to encourage greater two-way dialogue with the FDA on patient safety. Earlier this year the College alerted its members and the FDA about a letter from Boston Children’s Hospital regarding the Bovine Pericardial (Mitroflow) Bioprosthetic Valve. The ACC has been, and will continue to be, in contact with the FDA on this matter. The FDA has also recently proposed some additional steps that would provide a collaborative approach to facilitating product development with the hope that the steps will lead to expedited access to devices that address unmet medical needs. Additionally, the FDA has proposed new guidance that addresses the current balance between pre- and post-market data collection and when post-market data collection can be used to satisfy the FDA’s mission of ensuring device safety and effectiveness.

“Ongoing research using data from the College’s clinical data registries are also increasingly being used to track effectiveness and safety of drugs and devices,” said William Oetgen, MD, FACC, ACC executive vice president of Science, Education and Quality. “The changing health care environment is requiring us to strengthen partnerships with agencies like the FDA and we are rising to the occasion — successfully I might add.”

Clinical Topics: Cardiac Surgery

Keywords: Health Policy, Heart, Artificial, United States Food and Drug Administration, Device Approval, Centers for Medicare and Medicaid Services (U.S.), Patient Safety, Cardiology Magazine, ACC Publications

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