Skip to content

CQ Roll Call – Overhaul of Lab Test Regulation Possible This Year

CQ Roll Call – Overhaul of Lab Test Regulation Possible This Year

Key lawmakers hope to move legislation this year that aims to improve federal oversight of laboratory tests. And now two main industry groups who were previously in opposition on the issue are aligning on a strategy to lobby Congress to advance an overhaul.


Laboratory developed tests, or LDTs, are currently regulated by the Centers for Medicare and Medicaid Services. The Food and Drug Administration in 2014 released a draft guidance that would have created a separate review pathway at the agency for the tests. Opponents of that approach won a victory last year when FDA withdrew its final guidance.


But with the GOP now in control of both chambers of Congress and the White House, Rep. Michael C. Burgess of Texas, chairman of the House Energy and Commerce Health Subcommittee, said he wants to craft legislation this year. Burgess said, however, that work on a bill would not begin until President Donald Trump nominates someone to lead the FDA.


“The FDA needs a new commissioner and we’re probably going to start from there,” he told CQ Roll Call.


Trump during a meeting with pharmaceutical executives on Monday said his nomination to lead the agency would come “fairly soon.”


Lobbyists say Senate Health, Education, Labor and Pensions Chairman Lamar Alexander of Tennessee has also expressed interest in advancing legislation on lab tests. A spokesman did not immediately respond to a request for comment.


Industry groups are already coordinating on strategy and plan to lobby Congress to move forward, according to a draft letter obtained by CQ Roll Call.


“While there have been significant strides to improve the regulatory process for diagnostics, we believe there are critical opportunities for further reform through a risk-based approach,” the Advanced Medical Technology Association and the American Clinical Laboratory Association wrote. “We strongly support efforts to move bipartisan diagnostics reform.”


AdvaMed said discussions are ongoing. ACLA said in an email that it supports changes but prefers CMS, not FDA, to oversee the industry.


The potential partnership between AdvaMedDx, the diagnostic arm of one of the main medical device lobbying groups, and ACLA, the lobbying group for clinical laboratories, is striking.


AdvaMed was one of the most steadfast supporters of FDA’s approach outlined in the 2014 draft guidance, while ACLA was one of the most vocal opponents. The group threatened to sue the agency if it issued final guidance on the topic and even retained attorneys with experience before the Supreme Court.


The division between the two groups comes down in part to profits and the cost of federal oversight. When developing a new drug, medical device companies are typically required by the FDA to manufacture tests, known as companion diagnostics, that can determine if a patient will respond positively to a specific treatment. After federal approval, however, labs often create their own LDT to use in place of the companion diagnostic, cutting into the profits of the device manufacturer.


Under the current system, as long as that lab does not sell the lab test or use it outside its own facility it is not required to get FDA approval for it. The lab industry has argued that should FDA require facilities to submit their tests for approval, many labs would be unable to afford the associated fees.


Patient groups argue that FDA oversight is needed to ensure the tests currently in use are safe and produce accurate results. The American Cancer Society Cancer Action Network, Friends of Cancer Research and other groups wrote to Senate leaders last month urging Congress to “craft a consensus proposal to update FDA oversight of all diagnostics, including LDTs.”


The likely vehicle to try to move legislation on the issue would be the upcoming medical device user fee agreement, which outlines what industry pays for FDA initiatives and oversight.