INDUSTRY NEWS
FDA recently approved a new test for diagnosing avian influenza, which was developed by CDC (Atlanta). Through the use of an expedited review process, FDA completed the review and approved the new test within two weeks of CDC submitting its application.
FDA has administrative processes to ensure that new IVDs with profound public health importance can be prioritized and put on an accelerated approval schedule. The agency’s expedited review process is designed to make sure that new medical devices with important public health benefits are available for use as quickly as possible.
According to FDA’s guidance on Expedited Review of Premarket Submissions for Devices, the agency “considers a device appropriate for expedited review if the device is intended to diagnose or treat a life-threatening or irreversibly debilitating disease or condition and addresses an unmet medical need.” For example, the device’s availability is in the best interest of patients and provides a specific public health benefit.
The expedited review for CDC’s avian influenza test was made possible by preliminary communications and intense coordination between FDA and CDC staff. Such communications and coordination included up-front protocol discussions between FDA and CDC that took place in November 2005. FDA was also able to review information in real time and obtain real-time responses to questions from CDC scientists responsible for developing the test.
However, despite such claims by FDA, some industry analysts are skeptical about the expedited review process that CDC’s bird flu test underwent and believe FDA afforded the test favorable treatment.
“When this approval happened, I e-mailed an FDA official and asked whether CDC got special treatment,” says Glen P. Freiberg, vice president, regulatory, quality, and government affairs at Gen-Probe Inc. (San Diego). “That official responded by saying CDC was treated like anyone else, but… I’d like to confirm that a user fee was paid, that CDC is registered as a medical device manufacturer, and that its manufacturing facility has been inspected.”
FDA officials defend the expedited review process used for CDC’s test, and contend that the test did not receive any favorable treatment and underwent the same review processes.
“The expedited review process means that a new submission is important enough to break in line in the review queue, like going to the airport and getting to go ahead of the others because you are a VIP,” says an OIVD official. “However, the special treatment stops there. While the submission at all stages of premarket review goes to the head of the line, whether the desired rapid response is a yes, no, or more information is needed, depends on the quality of the submission.”
Steven I. Gutman, MD, director of OIVD, added, “CDC’s test was handled in the same manner as other tests that could have a significant impact on public health. The last test of this type was a West Nile virus test. The company had done its homework well, the submission was of high quality, and the review time was less than three weeks.”
Other industry analysts believe that, considering the heightened concerns regarding a potential avian influenza pandemic, politics may have played a role in expediting the review of CDC’s test.
“There is a bit of political science involved here,” says Thomas M. Tsakeris, president of Devices and Diagnostics Consulting Group Inc. (Rockville, MD). “Clearly, given the public visibility of these two public health agencies, it would not play very well if FDA asked too many questions of CDC, as FDA would assume that submitted test data reflected good science. I do not expect that CDC will face an FDA quality system regulation inspection any time soon.”
Additional information about FDA’s expedited review process can be accessed via the agency’s Web site at www.fda.gov/cdrh/ mdufma/guidance/108.html.
