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Originally Published IVD Technology September 2005
INDUSTRY NEWS
Surveillance of Web-based marketing a daunting task for FDA
Matt Grebow
In April, IVD Technology detailed FDA’s attempts to regulate sales of illicit home-use IVDs over the Internet (see "FDA monitoring Internet sales of illegal tests," p.15). Warning letters sent by the Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) during the last few months indicate that FDA’s concerns about Web-based marketing extend to laboratory and physician-directed tests as well.
On May 25, OIVD told BioImagene Inc. (San Jose, CA) that its Pathiam Web-based tumor-imaging software was being marketed on the company’s Web site as an IVD without marketing approval or clearance. The notice followed a similar letter sent to Agendia BV (Amsterdam, The Netherlands) on April 6 regarding its MammaPrint microarray assay for analyzing tumor samples from cancer patients.
In response to FDA’s warning, Bioimagene removed the controversial wording from its Web site. In July, executives at the company met with OIVD officials to discuss the necessary regulatory steps for commercializing Pathiam as a diagnostic; after the meeting, the company said it was preparing a preinvestigational device evaluation submission for the software.
The Molecular Profiling Institute Inc. (Phoenix)—the U.S. distributor of the MammaPrint—includes a statement on its Web site that the test has not been approved by FDA. A description of the assay on the company’s Frequently Asked Questions page refers to the MammaPrint as "a prognostic rather than a diagnostic test."
Despite the actions taken by FDA in recent months, Donald St. Pierre, deputy director for new device evaluation at OIVD, acknowledges that monitoring the marketing of tests over the Internet is a vast undertaking. "We’d like to take a more proactive approach, but we don’t have the funding and staffing available," he explains.
St. Pierre says that OIVD has not yet developed a formal plan to examine claims on manufacturer Web sites, although the office does investigate complaints made by consumers and industry, in addition to exploring dubious claims discovered by its own employees. In fact, according to St. Pierre, the majority of tips that OIVD receives derive from one IVD company alerting FDA about possible infractions by another company. Although the office’s current surveillance system will continue, he says, response to illegal Web marketing will be primarily "reactive."
St. Pierre believes that monitoring of device Web sites extends beyond OIVD’s purview, to the Center for Devices and Radiological Health (CDRH). "I do believe that there will be changes within CDRH and OIVD because we have been looking at the premarket/postmarket balance of regulation for devices for several years now as part of the Center’s Strategic Plan, where one of the main goals has been to regulate through the Total Product Life Cycle (TPLC). This TPLC concept was the reason that OIVD was created," explains St. Pierre.
However, he says that OIVD’s current priority is to focus on shoring up the Medical Device User Fee and Modernization Act. In particular, he is hopeful that the agency’s Turbo 510(k) electronic submission program will gain popularity among IVD companies and free up already-tight resources. Once the efficiency of the premarket review process has improved, the office will shift its attention toward tackling postmarket issues.
In the meantime, new Internet IVD device marketing regulations could arrive on the coattails of pharmaceutical reform. In April, Senators Chuck Grassley (R-IA) and Chris Dodd (D-CT) introduced legislation that would, among other things, increase postmarket scrutiny of prescription drugs by transferring drug safety oversight to a proposed Center for Postmarket Drug Evaluation and Research. Under a provision in the bill, within six months of the legislation’s enactment, CDRH, in conjunction with the Department of Health and Human Services and FDA, would be required to submit a report identifying deficiencies in current postmarket surveillance of devices and suggesting potential improvements.
For any IVD reform to be successful, though, OIVD says that ultimately FDA will need to evaluate the marketing of diagnostics separately from that of drugs. "I’m sure that CDRH will learn from what is going on in drugs and will apply whatever is appropriate to improve the surveillance of devices," says St. Pierre, but he adds, "If there are any device changes in the future, they should be based on device problems, not drug problems, because the two are vastly different."
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