American Association for Clinical Chemistry
Better health through laboratory medicine
January 2011 Clinical Laboratory News: Q&A with FDA’s Alberto Gutierrez


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January 2011: Volume 37, Number 1



Q&A with FDA’s Alberto Gutierrez

GutierrezNow at the helm of the Food and Drug Administration’s (FDA) Office for In Vitro Diagnostics (OIVD) for a year and a half, Alberto Gutierrez, PhD, shared withCLN how FDA is grappling with challenges related to new technologies, shifts in clinical practice, and a move toward greater transparency in the agency’s Center for Devices and Radiological Health, under which OIVD operates.

A major concern for laboratorians has been the agency’s foray into regulation of laboratory-developed tests (LDTs). FDA announced in a public meeting in July, 2010 that the agency planned to end its long-standing policy of enforcement discretion and begin regulating all LDTs under a new framework. A draft guidance explaining how this might work is expected sometime this year. Most recently, the agency participated in a forum in November sponsored by the American Clinical Laboratory Association and other laboratory groups. At the meeting, agency officials reiterated their promise that LDT oversight will be phased in over time and with a focus on high-risk devices.

What are the top three things you’d like to see OIVD accomplish in the next few years? 
The last decade has seen a tremendous change in both the type of clinical tests being performed and the quality of information derived from those tests. At the same time, many of the new tests are being offered as laboratory-developed tests (LDT). As identified by FDA, the Institute of Medicine, and several advisory committees to the department of Health and Human Service, LDTs can put patients at risk and create disincentives for manufacturers currently subject to FDA requirements to invest in developing innovative tests. For example, LDTs for HPV compete with FDA-approved tests without having demonstrated clinical performance, putting women at risk by either missing a potentially dangerous infection or wrongly identifying women as having an infection and sending them for potentially invasive procedures. I hope in the next few years to re-establish some balance while continuing to foster innovation in this rapidly developing field. Furthermore, I hope to strengthen the scientific base within OIVD and to continue applying the appropriate regulatory tools so that we constantly improve our efforts to protect and promote public health.

What accomplishments are you most proud of since you took your current position? 
I am most proud of the proactive and transparent approach that we have taken on important public health issues. This proactive approach can be seen in three important public meetings held in the last year, all of which emphasized the Center’s approach to solving problems through transparent dialogue. The first discussed issues with the accuracy, specificity, and off-label use of glucose meters in the clinical setting; the second looked at identifying ways to close existing regulatory gaps identified with LDTs; and the third explored advancements in developing diagnostic tests and biomarkers for tuberculosis.

I am also proud of the office’s advancements in reviewing companion diagnostics, particularly for cancer, as well as our efforts around the pandemic flu emergency. We issued an authorization for emergency use of a 2009 H1N1 diagnostic test within 24 hours of receiving an application and authorized an additional 17 diagnostic tests before the pandemic emergency was terminated. We also established an Office of Personalized Medicine with a talented staff who have already worked diligently to tackle some very difficult and thorny issues in personalized medicine.

What are FDA’s top challenges right now with IVDs?
Our top challenges are LDTs, the increase in point-of-care/waived technologies, and genome sequencing. With point-of-care testing, advances in technology and the desire to have a quick turnaround of test results are creating an incentive for many tests to move from the traditional laboratory—and the controls associated with them—to waived laboratories. Such tests have great public health potential, if appropriate attention is paid to their safety and effectiveness in waived settings.

The technology behind genome sequencing is also quickly becoming a viable test method for clinical laboratories. For FDA, this technology presents a major regulatory challenge. Our current regulatory framework requires that we regulate by the risk posed by the intended use, but this technology would allow for one test to have perhaps thousands of intended uses. Therefore, we will have to find ways to place appropriate controls so that we can assure safety and effectiveness in a reasonable way. 

What is FDA doing to speed the approval/clearance process for tests?
FDA is constantly re-evaluating our processes and practices to see how we can improve. This can be seen in the Center’s extensive effort to strengthen the 510(k) program, and the agency’s effort to be more transparent by pushing our performance towards meeting several goals, including performance in premarket review, on the Internet. Additionally, OIVD periodically reevaluates our risk classification scheme to see if changes in technology and medical, laboratory, and industry practices have shifted risk classification for devices we regulate. Currently we are performing such an assessment based on a study AdvaMed put together for several analytes. In general, the Center is striving for greater clarity and predictability in our programs—two necessary elements for continued progress and innovation in the medical device industry. The more predictable our device review, the more industry can focus on developing new products that will save and improve lives.

How do you think the proposed changes to the 510(k) paradigm are likely to affect IVDs? 
The Center has not finished putting together our action plan, so it is a little early for us to make that determination. However, the Center’s focus is on greater clarity, predictability, consistency, and transparency, which certainly applies to IVDs.

Can you say anything that would put laboratorians’ minds at ease somewhat about how regulation of LDTs will impact day-to-day operations of most labs? We are still working through the process of determining the extent of oversight that is needed—whether by FDA or through other mechanisms—but any impact will be in the long-term, phased-in based on the risk of the tests being performed, and designed to lead to an improvement in laboratory practice. In addition, we want to avoid any duplication with CLIA and will try to leverage CLIA and those who already engage in oversight of laboratory practice to the greatest extent as is practical.

How do you see the plan for FDA and CMS working more closely together affecting IVDs? 
We already work together extensively, using each other’s strengths. Clearly any framework that is developed will need to understand and leverage the regulatory oversight already applied to laboratories so that the regulatory burden is not unnecessarily and wastefully increased.