TRENDS & PERSPECTIVES
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Gutman |
After 17 years with FDA, Steven I. Gutman, MD, who has been director of OIVD since helping to establish it in November 2002, has left the office to pursue a career in academia. Gutman will become a professor of pathology and a founding member of the University of Central Florida’s new medical school.
Don St. Pierre, the associate director for policy and operations at OIVD, will assume Gutman’s duties on an interim basis and chair the selection committee while FDA secures a replacement.
“We hope to have a pool of highly qualified candidates, but Dr. Gutman will be a difficult man to replace,” St. Pierre said. He added that since the rest of the management and staff will remain, it will be business as usual at OIVD. “We are a seasoned group and have worked as a collective, not independently, so we are well positioned to carry on the policies that are in place as well as any new policies that develop.”
However, some in the IVD industry do not see business as usual as the best plan. “I’ve been on record as saying the entire IVD paradigm we are under needs to be examined in light of the European approach,” said Glen P. Freiberg, president of RCQ Consulting (San Diego). “What we go through as far as the regulatory burden for most IVDs, I’m not convinced is justified.”
Freiberg pointed out that several IVD companies have created tests that might fall under the draft IVDMIA guidance but seek ways to circumvent FDA. “The idea that a test could be created in one laboratory or university and fit a tiny subcategory of test types parses the field too far and avoids the issue of reasonably necessary and consistent regulation.”
While OIVD must play by Congress’ rules and cannot control this regulation entirely, OIVD can focus more tightly on what laboratories manufacture and apply compliance regulations consistently. “New leadership will have the opportunity to take this in a new direction and update the CLIA/FDA policy approaches,” Freiberg said.
“Whoever takes over at OIVD is being put into a key regulatory position,” said Jeffrey N. Gibbs, JD, director at Hyman, Phelps & McNamara (Washington, DC). “The new director of OIVD will need to help ensure that new diagnostic tests are safe and effective, while simultaneously recognizing that there should not be undue barriers to making these tests readily available.”
“Dr. Gutman will be a hard act to follow,” said Donald M. Powers, PhD, president and principal consultant at Powers Consulting Services (Pittsford, NY). “He brought a good appreciation of the laboratory’s needs.” However, it is unfortunate timing, he said, “as OIVD is actively working with AdvaMed (Washington, DC) to meet commitments made following passage of the FDA Amendments Act. Transition to new leadership could slow the process.”
Industry analysts have strong opinions about what OIVD should focus on during this transition and beyond. While Freiberg highlighted IVDMIAs and CLIA standards, Khatereh Calleja, JD, associate vice president of technology and regulatory affairs at AdvaMed, said, “The MDUFMA goals are critically important for the IVD industry, and we expect FDA to continue its efforts to meet these important commitments with industry on a timely basis.” Calleja also said that Medicare payment policies and payment levels for diagnostics clearly are outdated and severely flawed.
Thomas M. Tsakeris, president of the Devices & Diagnostics Consulting Group Inc. (Rockville, MD), commented that he greatly admired Gutman’s success in elevating the profile and importance of IVDs. “However,” he said, “with the growth of the OIVD bureaucracy, management of review policies and processes has become disconnected, unpredictable, and, in some cases, downright dysfunctional. Many of the problems are due to the addition of new review staff with strong academic credentials but little regulatory perspective insofar as being able to prioritize risk in making regulatory decisions.”
Glen Fine, executive vice president at the Clinical and Laboratory Standards Institute (CLSI), said that Gutman was very active with CLIA as far as writing standards and best practice guidelines with the organization. “Steve has always been a real champion of having everyone who is affected be included, instead of being a bureaucrat with a gavel.” Fine said he hopes that OIVD will continue its history of ensuring openness, inclusiveness, and transparency.
Other key areas that the new OIVD director will have to consider are genetic testing; the release of the IVDMIA guidance document; addressing companion diagnostics, including those influencing personalized medicine; and reclassification of some diagnostics. St. Pierre highlighted the importance of continuing to improve postmarket safety programs and integrate pre- and postmarket programs, maintaining a high level of performance and productivity, and helping to facilitate the introduction of quality IVDs into the marketplace.
