Originally Published IVD Technology March 2005
INDUSTRY NEWS
The potential fallout from drug controversies on IVD regulation
Richard Park
The recent negative press surrounding certain high-profile pharmaceuticals has raised concerns regarding the effect such news may have on IVDs. Some IVD industry analysts believe the withdrawal of Vioxx from the market and the newly revealed risks related to Celebrex may lead to increased scrutiny of other medical technologies, such as IVDs, seeking FDA approval.
“Oversight by Congress during the generic-drug scandal in the early 1990s did spill over and impact devices,” says Tom Tsakeris, president of Devices and Diagnostics Consulting Group Inc. (Rockville, MD). “Even though the situation with Vioxx and Celebrex is quite different, sustained negative publicity of any kind on FDA activities can permeate the whole organization. Although I cannot assert at this time that the Vioxx and Celebrex publicity has had any immediate effect on IVDs, it could, if more news of adverse reports of other drugs, or devices, starts to emerge.”
Some industry analysts believe that the Vioxx and Celebrex situations have already had an effect on the regulation of IVDs. “It is my understanding that we are beginning to experience an increase in the agency’s scrutiny concerning 510(k) premarket notifications and premarket approval submissions,” says Leif Olsen, a regulatory affairs specialist at Hogan & Hartson LLP (Washington, DC). “As a result, we are anticipating longer review times and more questions before IVD products are cleared or approved for marketing.”
Officials at the Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) assert that FDA does not plan to change the way it oversees the regulation of IVDs. “There is no current agenda at the working level to make major changes in the IVD regulatory program,” says Steve Gutman, MD, the OIVD director. “Since our reorganization, we have been working hard to standardize reviews, make them pragmatic, risk-based, and grounded in good science, and increase transparency. There is of course some uncertainty in terms of future regulatory programming. Nonetheless, I would not expect major changes in the regulation of IVDs because while it isn’t perfect, it isn’t broken. At the same time, this is not intended to imply there are not always opportunities for improvement.”
Other industry analysts point out that the risks in using drugs versus diagnostic tests are so different that separate FDA centers have been established. Consequently, the approaches to product evaluation and FDA clearance are different.
“Diagnostic tests are rarely used alone to make medical decisions,” says Glen Freiberg, vice president of regulatory, quality, and government affairs at Gen-Probe Inc. (San Diego). “Therefore, the risks right from the start are much less. As part of a diagnostic test’s evaluation, common or projected interfering substances are checked to see if it will be valid in the vast populations for whom it is intended. In the case where a diagnostic test fails in the field, that is, a recall situation, it is usually because of a detectable test failure, not an interaction with the patient.”
However, some industry analysts believe that the Center for Devices and Radiological Health has not done a good job of distinguishing itself within FDA. Since the Center for Drug Evaluation and Research seems to take the lead and is viewed as the sophisticated older sibling, legislators understand drugs but not devices.
“This is a concern for the entire medical device industry,” says Carolyn Jones, JD, associate vice president for technology and regulatory affairs at AdvaMed (Washington, DC). “For example, FDA’s ‘Critical Path Initiative’ describes a drug development process, but does not describe a device process. The assumption is that they are the same. Because FDA itself has done such a poor job of distinguishing between drugs and devices, we will get swept up into the feeding frenzy that will result from the Vioxx issue. Legislation on registration of drug and device clinical trials and their outcomes is already being considered.”
Copyright ©2005 IVD Technology
