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FDA Will Encourage Voluntary Reporting of LDT Adverse Events to MedWatch System

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Originally published on Feb. 5.

By Turna Ray

The US Food and Drug Administration will encourage doctors, consumers, laboratories and others to voluntarily report adverse events and malfunctions associated with laboratory-developed tests to its MedWatch system.

"We are still not going to enforce our reporting from the laboratory developed tests, but there is a mechanism for voluntary reports" through MedWatch, Alberto Gutierrez, director of FDA's Office of In Vitro Diagnostic Device Evaluation and Safety, said at a meeting this week of the HHS Secretary's Advisory Committee on Genetics, Health, and Society.

"We are planning to advertise this and hope that people actually report any issues voluntarily so that we can go ahead and take a look at what kind of adverse events we are seeing among laboratories," Gutierrez said at the meeting, which was held in Washington, DC.

The notice comes nearly two years after the Secretary's Advisory Committee on Genetics, Health, and Society recommended to HHS that the FDA establish a mandatory, web-based registry for all laboratory-developed tests [see PGx Reporter 05-28-2008].

In the report, SACGHS asked HHS to appoint an agency that would develop the registry. Furthermore, while the proposed registry is currently in the process of being set up, SACGHS advised HHS to incentivize the voluntary registration of laboratory tests, and to encourage labs to make publicly available their test menus and analytical and clinical validity data for these tests.

Currently, there is a dual regulatory pathway for diagnostic tests. The FDA regulates diagnostic test kits and certain high-risk LDTs, such as in vitro diagnostic multivariate index assays. However, for the majority of LDTs, the FDA practices enforcement discretion, leaving regulatory oversight to the Centers for Medicare & Medicaid Services under the Clinical Laboratory Improvement Amendments.

As such, there are important gaps in the reporting and regulation of the majority of LDTs. Essentially, there are no requirements and no system for reporting adverse events associated with LDTs.

"It's not just the premarket …clinical quality of the tests that concerns us, but there are a lot of things in the post-market that the FDA does that laboratory tests are getting by with because we're doing enforcement discretion," Gutierrez said.

MedWatch, launched in 1993, collects reports of adverse reactions and quality problems associated with drugs and medical devices, as well as for dietary supplements, cosmetics, medical foods, and infant formulas. Healthcare professionals, consumers, and patients can voluntarily report problems with such products online, by phone (1-800-FDA-1088), or by faxing (1-800-FDA-0178) a one-page reporting form.

However, because the FDA doesn't have a mechanism in place that allows labs to submit such reports, adverse events associated with LDTs that might be reported to the agency fall through the cracks.

Currently, IVDs regulated by the FDA receive a product code, which the agency uses to track information and trends reported on the test. "Since we don't have a product code that says, 'This would be a laboratory test,' if somebody does report for some reason … it would get lost among all the other data we have," Gutierrez said.

Recognizing this problem, the FDA is "trying to create a mechanism where we have a protocol specific for laboratory developed tests." As part of its new voluntary reporting mechanism, the agency will assign one analyst to track trends and issues associated with LDTs.

The LDT reporting system is expected to begin operating in the next few weeks, though the FDA still needs to train contractors and experts on appropriate handling of data reported on LDTs, Gutierrez said.

"We have already started asking people to report," he said. "The biggest issue is that … we get thousands of medical device reports. The way that MedWatch and MDR works out [is that] there are actually contactors that take the reports and put them in the buckets. We need to train them and make sure they are putting them in the right buckets."

According to Gutierrez, in some cases, FDA will work with CMS to take regulatory action for problems associated with LDTs reported through MedWatch.

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