FDA Oversight Lags for Consumer Apps, but Improves for Industrial Lab Tests

As consumer interest in medical treatment becomes increasingly gratified with downloadable apps and as industry develops ever more diagnostic tools, the opportunities for misinformation and misadventure increase as well. This summer, the FDA admitted that it could little about the former, but will regulate the latter.

As reported on PBS News Hour, the quantity of new health applications available on the market every year outpaces the FDA’s ability to regulate them.

Some Congressional representatives have advocated for a special department within the FDA to address the proliferation of mobile health apps, and to regulate them, but the idea has been rejected as impossible to fulfill by the agency’s policy advisors.

The feds have reviewed about 100 health apps, and they have published guidelines for the app industry and its own staff that, according to the story, frees developers of health-care information technology to create products free of regulatory oversight, even if they cross the line between medical devices and information. Those guidelines were a follow-up document to last year’s guide to help app developers know if their product would qualify as one that requires oversight.

The latest document pretty much confirms that the FDA’s intention is not to scrutinize all health apps, especially ones deemed low-risk, such as exercise tracking tools. It intends to focus on apps used as accessories for a regulated medical device or those that “transform a mobile platform into a regulated medical device.”

So app users, make sure you understand the difference. To learn more about how the FDA oversees medical apps, link here.

Diagnostic tests are a different kettle of fish, regulation-wise. As MedPageToday.com reported, the FDA will assume regulation of so-called “home brew” diagnostic tests developed and used within individual clinical laboratories. The goal, according to its announcement, is “to ensure that certain tests used by health-care professionals to help diagnose and treat patients provide accurate, consistent and reliable results.”

The FDA notified Congress that it will propose a framework for laboratory developed tests (LDTs) designed, manufactured and used within a single laboratory, such as some genetic tests and tests that are used by health-care professionals to guide medical treatment for their patients.

Currently, labs certified under a program managed by the Centers for Medicare and Medicaid Services may develop and use their own diagnostic tests internally without FDA oversight. Many genetic tests and some unique infectious disease diagnostics fall into this category. Reagents – substances or compounds used in chemical analysis or other reactions – are regulated by the FDA, but no clinical data are needed for their approval.

According to MedPageToday, FDA Commissioner Margaret Hamburg said the agency was “very concerned” about the growing use of LDTs for cancer and other serious diseases because their accuracy hasn’t been verified. She professed awareness of faulty LDTs that could expose patients to inaccurate diagnosis, which in turn puts them at risk for getting the wrong treatments.

Until now, the feds pretty much laid off these internal lab tests because LDTs were used only for rare or low-risk diseases. Officials didn’t believe that regulating them would be helpful or necessary. But advances in molecular biology have greatly expanded the ability of clinical labs to develop and market tests for a wide range of disease markers, and that means the potential for risky error is so large it should be monitored.

The agency also justified its expanded authority because all diagnostics should be subject to a common standard. “While the FDA has historically exercised enforcement discretion over LDTs (generally not enforced applicable regulatory requirements), today these tests may compete with FDA-approved tests without clinical studies to support their use,” its statement said.

As MedPageToday noted, the FDA already oversees direct-to-consumer tests regardless of whether they are LDTs or traditional diagnostics.

The FDA’s proposal for stronger LDT regulation adds a layer of patient protection especially to the burgeoning field of personalized medicine. That’s treatment customized according to a patient’s unique, individual traits and has application, for example to things like what kind of chemotherapy, how often and in what dose should be given to a cancer patient with a certain genetic profile.

Although the additional oversight is welcome for patient safety, it won’t happen overnight – the FDA plans to roll out the complete program over several years. Industry, as well as the public, will have the opportunity to comment on the proposal. To learn more, link here to the FDA announcement.

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