Policy, Diagnostics

FDA tasks Congress with tightening diagnostics regulation

Loosely regulated diagnostics are leading to improper patient care and burgeoning medical costs, FDA and CMS are arguing to Congress – which is why they want to tighten up approval processes.

Too many medical errors – and costs – are stemming from inadequate regulation of diagnostic tests, the Food and Drug Administration is contending. The agency is calling for stricter oversight of medical tests, testified before Congress to argue its case in conjunction with the Centers for Medicare & Medicaid Services.

FDA also issued a series of case studies backing up its point that these diagnostics can prompt abortions, encourage unnecessary surgeries, and increase medical costs – as well as allow life-threatening diseases slip under the radar while misdiagnosing others.

After all, many laboratory developed tests, or LDTs, aren’t subjected to the same kind of regulatory oversight that pharmaceuticals or medical devices require – or even commercial laboratory tests. The laboratory tests developed in-house by diagnostics companies, and have a different set of CLIA standards. It’s gotten to a point where diagnostics companies actually find it more beneficial to sidestep the regulatory process as much as possible, FDA contends – and the patient suffers in the end.

“Despite the contention from some that ‘CLIA is enough,’ all of the tests described as problematic in this report were offered from laboratories following the minimum requirements of CLIA,” the FDA report says.

The New York Times points out that, as evidenced in last week’s Congressional hearing, this has become quite a politicized issue:

The Obama administration is moving to assert its enforcement authority over such laboratory-developed tests, saying they have become more complex, more widely used and more similar to commercial tests that the government has regulated for nearly 40 years.

The regulations around laboratory developed tests are antiquated, having originated in the 1970s when such tests were reserved for “diagnosing rare diseases and conditions in small numbers of patients,” the report says.

Since, diagnostics have become extraordinarily widespread – and must be put through the same regulatory rigors that other sectors in the life sciences industry face.

“As the field of medicine evolves, the need for accurate, reliable and clinically meaningful tests is essential,” FDA says. “For instance, the advancement of precision medicine depends upon accurate diagnosis in order to better target therapies. But inaccurate or unreliable LDTs and unsupported or disproven claims can undermine progress in precision medicine and other fields.”

Still, there’s a segment of Republicans that support keeping the diagnostics industry as-is, as New York Times points out:

But Representative Michael C. Burgess, Republican of Texas and a physician, expressed concern that the proposals “could stifle medical innovation and open the door to federal regulation of the practice of medicine.”

FDA has identified nine areas of deficiency in the diagnostics industry:

1. Lack of evidence supporting the clinical validity of tests: Patients aren’t necessarily told about the accuracy of the tests they’re undergoing, and may agree to clinical decisions that aren’t in their best interest. FDA says a tightening of regulations would improve the practice of evidence-based medicine – because it’d help clinicians and patients have confidence in the test result.

2. Deficient adverse event reporting: Medical devices, for instance, have to be meticulous about reporting adverse events – but negative outcomes from using diagnostics aren’t regularly monitored by a governing body.

3. No premarket review of performance data: “The time to evaluate the safety and effectiveness of a product is before it is marketed, not after it has been used by thousands of patients,” FDA says.

4. Unsupported manufacturer claims: The diagnostics industry is still generally able to make unsupported claims of its efficacy with little regulatory backlash. FDA plans to change that.

5. Inadequate product labeling: Many diagnostics were found to be improperly labeled.

6. Lack of transparency: “Patients and providers may not even be aware that an uncleared/unapproved (laboratory developed test) has been used or that an FDA-cleared/approved test could have been used instead.”

7. Uneven playing field: “Under the status quo, manufacturers have every incentive not to seek FDA clearance/approval, and the public is thus denied the advantages and improvements in scientific rigor the research and review process ensures.”

8. Threats to the scientific integrity of clinical trials: Diagnostics have become a critical component of many clinical trials – but their potential inefficacy could muddle results of these studies.

9. No comprehensive listing of all LDTs currently being used: It’s the Wild, Wild West out there in terms of medical testing – there isn’t a reliable database or assessment system to demarcate cleared and dodgy diagnostics.

[Image from Flickr user rosemary]