Update: The FDA post-election statement on delaying implementation of the agency’s draft guidance on LDTs affirms the status quo – for now. The delay allays the concerns of some stakeholders about potential effects of greater FDA involvement in LDT regulation, such as slowing innovation in diagnostics and patient access to the most advanced diagnostics and, in some cases, access to therapeutics for which novel diagnostics identify patients likely to respond to treatment.

On the other hand, the delay does nothing to address the concerns of other stakeholders about potential patient risks associated with treatment decisions based on LDTs in the existing regulatory framework (examples below in the original version of this blog post). Health Decisions hopes that stakeholders can go beyond merely maintaining the status quo and agree on a regulatory approach that better protects patient interests both in timely access to innovative diagnostics and therapeutics and in assurance that novel diagnostics provide a reliable basis for treatment decisions. The current situation seems to call for achieving equipoise between two important priorities rather than simply maintaining the status quo without addressing legitimate issues raised by a variety of stakeholders.

Original Post

It is now more than two years since FDA issued its Framework for Regulatory Oversight of LDTs and yet diagnostics developers and their investors must still contend with uncertainty as to how development of their products is to be regulated. Centers for Medicare & Medicaid Services (CMS) currently regulates LDTs under the Clinical Laboratory Improvement Amendments. However, CMS and FDA agree that FDA has more appropriate resources for regulation of LDTs.

Industry perspectives vary. Laboratories providing tests as a service are concerned about the potential burden of FDA regulatory oversight of LDTs. Diagnostics companies selling IVDs question the fairness of having to submit many of their products for rigorous FDA review, often including assessments of clinical utility, when laboratories are offering competing LDTs nationwide without such review. IVD companies can also point to the 20 case studies of possibly problematic LDTs that FDA published in 2015 as public health evidence for increased regulation.

AMP Annual Meeting 2016 We look forward to discussions of proposed frameworks for regulation of LDTs, as well as diagnostics development projects, at the AMP Annual Meeting November 10-12, 2016 in Charlotte, NC. We invite you to stop by booth 413 or schedule a meeting with a Health Decisions representative.

All stakeholders agree about the importance of ensuring the validity of diagnostics used as a basis for treatment decisions. There is less unanimity about the importance of demonstrating the clinical utility of novel tests before labs begin offering them as a service. In addition to concerns about cost, the industry and many clinicians are aware that a requirement to demonstrate clinical utility before utilizing an LDT in patient care would likely cause substantial delays in the availability of many tests and hamper clinical decision-making in areas of rapid progress.

Ensuring Validity vs. Increasing Costs & Hampering Medical Progress

The challenge of striking a balance between allowing timely access to new tests and related treatments and ensuring the validity and clinical utility of such tests has led various stakeholders to propose different regulatory schemes as an alternative to FDA’s proposed framework. Organizations proposing regulatory schemes include:

Thus, with the FDA’s proposed framework, there are at least four proposed regulatory frameworks to consider. In addition, two other organizations have voiced opinions on appropriate regulatory frameworks for LDTs without putting forward their own proposals as such. The American Clinical Laboratory Association (ACLA) has published a white paper challenging FDA’s authority to regulate LDTs. The Advanced Medical Technology Association (AdvaMed) differs with ACLA, having expressed support for a risk-based approach that favors greater FDA involvement in regulation of LDTs. Finally, there are efforts in Congress to draft legislation to change the regulatory framework for LDTs, primarily based on an external proposal or proposals.

The Time Has Come to Agree on a Regulatory Framework for LDTs

Health Decisions consults with and performs sample collection, validation and clinical utility studies for many diagnostics developers. It is clear to us that prolonged uncertainty about the regulatory framework for LDTs will likely reduce investment and delay the availability of a number of LDTs and IVDs. While IVD developers are already regulated by FDA, any change in the regulatory framework for LDTs has the potential to affect the competitive environment for IVDs as well. In addition to concerns about ensuring test validity and timely availability, Health Decisions is concerned about the effect of regulatory uncertainty on investment and R&D activity in the entire diagnostics industry, services and kits alike. Regulatory uncertainty itself may have the effect of limiting or delaying the options available to healthcare providers and patients now and in the future.

Health Decisions is prepared to work under whichever regulatory framework for LDTs prevails. Our main concern is for the timely emergence of a regulatory framework that removes uncertainty and allows companies to make reasonable judgments about development strategy and R&D investments. We urge all stakeholders to consider the importance of coming to a timely agreement about a suitable regulatory framework rather than prolonging the current atmosphere of uncertainty.

The longer the current uncertainty prevails, the more deleterious the consequences for the diagnostics industry, healthcare providers and patients. For the sake of all concerned, the time has come to settle on a new regulatory framework for LDTs.