FDA Issues Response to Draft Legislation to Regulate LDTs

In its comments, FDA said it favored a risk-based approach to regulating LDTs, in vitro tests

DURING HER ADDRESS TO THE ANNUAL MEETING of the American Clinical Laboratory Association meeting in March, Rep. Diana DeGette (D-Colo.) explained why she and others in Congress had developed the Diagnostic Accuracy and Innovation Act (DAIA), a discussion draft that would give the FDA authority to regulate laboratory developed and in vitro diagnostic tests. At the time, she and other members of Congress wanted the FDA to respond to the draft, she said.

Tests in a Gray Area

Earlier this month, the FDA responded to her request. It provided an overview and technical comments on LDTs and in vitro tests. These are tests that fall into a gray regulatory area because CMS oversees labs but the FDA regulates tests.

In its comments on DeGette’s proposal, the FDA said it favored a risk-based approach under which it would monitor assays marketed as in vitro clinical tests and oversee premarket authorization. It would also ensure that, in the future, tests labs develop will have a path to market. The FDA further said it wants the authority to remove tests from being sold if they pose risks to public health.

DeGette wants the legislation passed by year end, which would be a challenge for Congress given the workload it would need to finish by then, according to published reports. A spokesperson for Larry Bucshon (R-Indiana), a heart surgeon who is DeGette’s co-sponsor, said, “We are working diligently with the goal of getting this done this year,” according to reporting from Sarah Owermohle at Politico.

The FDA’s proposals depart from the language DeGette and Bucshon proposed in the DAIA, according to reporting from Turna Ray at GenomeWeb. DAIA was drafted with extensive input from stakeholders, she wrote.

On Aug. 3, the FDA said it wanted a bill that would include provisions related to premarket and provisional approvals and a precertification program for certain tests. Also, it wanted explicit authority to revoke approvals and to take corrective action against test developers to protect the public, Ray reported.

The FDA favors a regulatory approach that would allow the agency to monitor tests that are currently on the market while also ensuring that labs can bring new tests to market under what it calls a flexible and efficient pathway, she added.

“According to the FDA, its proposals aim to establish a framework that doesn’t hinder access to tests already on the market or for rare diseases, for example, but where the agency also has the power to remove tests from the market that put the public health at risk,” Ray wrote.

Some experts in health policy said the FDA’s proposal was more than a reaction to the DAIA and was instead an entirely new bill, Ray reported.

Those in the clinical lab industry who have seen the FDA’s proposal said they needed more time to review the agency’s detailed recommendations and had been expecting line edits to what DeGette and Bucshon proposed last year in their working draft of the DAIA.

The FDA’s proposal includes a definition for in vitro clinical tests (IVCTs) that is different from that included in the draft bill that DeGette and Bucshon proposed, Ray reported. Their draft bill defines an IVCT as a laboratory test protocol or a finished product (test kit) used in disease detection, screening, prediction, and monitoring, and for selecting treatment based on analysis of human samples, she wrote.

But the FDA’s response includes a definition in which the agency said it would consider test protocols, test platforms, and software used for these same purposes to be IVCTs, Ray explained. The FDA has told legislators that, as the draft bill from DeGette and Bucshon is written, it could leave test platforms with insufficient regulatory oversight, she added.

“Notably, the FDA does not specifically mention the terms ‘finished product,’ ‘laboratory test protocol,’ or ‘laboratory-developed test’ in its definition of IVCTs or anywhere in its legislative proposals,” Ray reported.

Regulating LDTs

In 2014, the FDA released draft guidelines outlining a risk-based approach to regulate LDTs, saying it would introduce this approach over nine years. Historically, the federal Centers for Medicare and Medicaid Services have regulated LDTs under CLIA. The 2014 proposal got heavy criticism from clinical labs and other stakeholders and was later withdrawn. In January 2017, the FDA said it would not finalize guidance on the regulation of lab-developed tests (LDTs). It has now responded to requests from the lab industry and others to develop a new regulatory approach.

13 Groups Issue Statement about FDA’s Comments

IN RESPONSE TO THE FDA’S COMMENTS to the draft language in the proposed Diagnostic Accuracy and Innovation Act (DAIA), a group of 13 organizations, including the American Clinical Laboratory Association, the Clinical Laboratory Management Association, and the American Society of Clinical Oncology, had nothing but praise for the FDA but said little about the specifics in the FDA’s proposal.

“We are committed to continuing to work with the House Committee on Energy and Commerce and the Senate Committee on Health, Education, Labor and Pensions to advance diagnostic reform legislation expeditiously so that comprehensive reform may be enacted in 2018, the group said in a letter to members of the leadership of both committees.

The FDA proposal, “represents an important and necessary next step in the pursuit of comprehensive legislative reform,” the group added.

The group of organizations that represent clinical labs, patient advocates, providers, and diagnostic manufacturers said they support “modernizing the regulatory framework for clinical laboratory diagnostics, including laboratory-developed tests (LDTs) and in vitro diagnostics (IVDs). Such reform is critical to ensure that patients and providers have access to innovative and high quality laboratory diagnostics, they added.

In addition to the ACLA, the CLMA, and ASCO, other groups that signed the letter are AdvaMedDx, the American Cancer Society Cancer Action Network, the Biotechnology Innovation Organization, the Coalition for 21st Century Medicine, the Diabetes Patient Advocacy Coalition, Friends of Cancer Research, LUNGevity Foundation, the National Alliance on Mental Illness, and the Society for Women’s Health Research.


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