AT TCT 2016

WASHINGTON (FRONTLINE MEDICAL NEWS) – Regulators from two continents are slowly inching toward more common ground when it comes to device approvals, a move that should strike a better balance between the time to approval and safety of the products.

It is no surprise that for devices to be approved in the United States, a much more rigorous evidence standard exists than it does in Europe, but the Food and Drug Administration is looking for ways to make changes to allow for quicker approval times without compromising safety.

Meanwhile, across the Atlantic, European regulators are looking for increased evidence requirements that will not stifle innovation.

“Clinical trials meant for regulatory processes may be the only endeavor in the United States which is getting less efficient over time … other than polling booths in the election,” FDA Commissioner Robert Califf, MD , told attendees at the Transcatheter Cardiovascular Therapeutics annual meeting.

However, health information technology may help relieve some inefficiencies going forward.

“If we combine quality registries, claims data, the evolving improving electronic health records, and the data warehouses that all of our health systems have, we can conduct prospective, observational, and clinical trials at a dramatically lower cost, answering many more questions per unit of time,” Dr. Califf added.

Other areas that will help improve the efficiency of the U.S. approval process is the work on developing a framework to bring feasibility studies back to America.

“I want to really accelerate that because we are hearing from a lot of people that they want to access the technology early; it’s the right thing to do, and we are hearing from industry that they’d like to work in the United States,” he said.

However, that is going to require one group that is generally more risk adverse to be willing to participate more in the process.

“The main limiting factors at this point in time are the health systems that we are all working in,” Dr. Califf noted. “They are very risk adverse. So while it is nice to argue and advertise that your interventional cardiologists are the best in town on your billboard, protecting those interventional cardiologists to do the high-risk, early studies that are really needed to develop devices is a different matter.”

He called on doctors to go back to their health systems to help better develop those early feasibility pathways to help bring some of that innovation back the United States.

Finally, Dr. Califf addressed the idea of developing evidence that can function not only for device approval, but for payment as well, especially as reimbursement systems are becoming more value driven.

“We are going to move to a system where reimbursement will increasingly move away from fee for service and increasingly gravitate to payment for value,” Dr. Califf said. “In order for this to work, we’ve got to develop the kinds of clinical trials [that include] the calculation of value, so the winners can be promoted on a wider scale and the procedures and technologies that don’t provide incremental value are left behind.”

He continued: “We need your help in figuring out the common source of information so that the FDA can make its decision – which is different from CMS’s decision – but where there’s a continuum of knowledge that allows for products to be approved if they are worthwhile, and then to be paid for and allowed to be marketed.”

Meanwhile, developers are facing a different situation in Europe, where more regulation and more stringent evidence standards could be coming down the pike.

“Currently operating within Europe, the level of evidence is defined by the manufacturer,” Alan Fraser, MD , a cardiologist at University Hospital of Wales, Cardiff, and chairman of the Committee on Regulatory Affairs at the European Society of Cardiology, said during his presentation at TCT. “The manufacturer needs to identify the performances of the device. The key word is performance rather than effectiveness as you might expect in other jurisdictions.”

Dr. Fraser noted research that has shown that devices first approved in Europe, compared with their U.S. counterparts, are associated with an increased incidence of recalls or safety alerts.

That being said, he noted that there are several proposed regulations that would increase the evidence requirements related to regulatory approval that manufacturers could face in the coming year, a challenge as it will require some level of harmonization across countries and regulatory systems within each country.

“In Europe, we are on the dawn of a new era regarding medical device assessment, but it is going to pose a very large challenge for our colleagues in the regulatory agencies because of their personnel, funding, and the integration between all these bodies and national systems. There are also tremendous challenges for us as physicians to ensure that we seek the evidence, we assess and contribute to it, and particularly now, that we also routinely take part in new systems for postmarket surveillance,” he said.


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