ACC Corner | Innovation vs. FDA Process: At Odds?

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 - Jack Lewin, MD
Jack Lewin, MD

As technologies advance, it is critical that our processes for evaluating them also evolve. This is no small task, but it is necessary to ensure that U.S. patients have access to medical care based on the most current science. While we live in an age of blockbuster drugs and devices, seemingly promising therapies also have failed in a very public way. We must determine the appropriate balance between risk and speed-to-market.

Innovation and protection of public health are both important; however, determining the proper balance between the two is both controversial and a challenge. We have a unique opportunity because the FDA and medical device industry are currently negotiating new goals and timelines for the review of device applications. FDA leadership has repeatedly expressed interest in examining the 510(k) process, and has taken recent steps toward change, with added pressure from July recommendations by the Institute of Medicine. The pharmaceutical industry also has concluded negotiations with the agency, with the biologic companies on its heels. Congress will take up the reauthorization of the drug and device user fee programs and consider user fee programs for biologics and generics in 2012.

Today's economic climate demands that we conduct rigorous, efficient analyses. Clinical trials remain the gold standard for evidence-based developments. However, clinical trials are conducted in a vacuum. Patients must meet certain ideal criteria, facilities and physicians are hand-picked for participation and the evidence is closely reviewed.

Clinical trials cannot fully predict all potential outcomes of the real world, and there are certain results we will never see or understand until a product is released on the commercial market and used in hospitals and practices. This is where a fully developed post-market surveillance system can help.

It is essential that we continue to gather data on pharmaceuticals and devices to observe usage and effects in the real world. The goal is not to study or experiment on patients, but rather to continue to understand the long-term effects of products used by larger patient populations with various characteristics and combinations of pre-existing conditions. By doing so, we learn more about how to best treat our patients.

This is where registries can make an impact. The American College of Cardiology's (ACC) National Cardiovascular Data Registry (NCDR) tracks physician-based data on various cardiovascular procedures, including cardiac catheterization, implantable cardioverter-defibrillators (ICDs), MIs, among others. The Society of Thoracic Surgeons (STS) collects similar data.

The primary purpose of such registries is the improvement of patient care by assessment of physician performance. Registry data also can be used to locate safety signals.

Several years ago, an evaluation of the NCDR led to the detection of problems with a device lead and to its removal from the market. NCDR's ICD registry is being used by Boston Scientific to comply with post-approval study requirements by the FDA for devices to treat arrhythmias, and the STS and NCDR registries together will begin tracking transcatheter valve therapies used to treat patients with inoperable aortic stenosis. These new registry surveillance and safety systems can track patients who receive new or experimental devices and drugs much less expensively than older style clinical trials that use a smaller cohort of patients.

The FDA can apply these tools to better track patient safety and to bring new clinical innovations to market with greater confidence. The agency must have the full support of Congress and the U.S. public to develop the necessary post-market surveillance infrastructure, including funding to support these kinds of new and advanced clinical data repositories. Through additional support for post-market surveillance, the FDA can provide the public with improved access to new technologies, while better managing potential safety risks and concerns regarding effectiveness, which are two primary components of the FDA's mission.

Dr. Lewin is CEO of the American College of Cardiology.