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May 5 — The House Energy and Commerce Committee could hold a hearing in late May on draft legislation that would alter how the government approves lab tests, an attorney said.
Plans for the hearing aren’t final, and when it occurs is at full discretion of the committee, Ralph Hall, an attorney with Faegre Baker Daniels in Minneapolis, said May 5 at a session of the Food & Drug Law Institute (FDLI) conference.
Hall works with an organization, the Diagnostic Test Working Group, that wrote the draft bill. The working group comprises lab and device companies.
Potential legislation on lab tests comes as the Obama administration is considering sweeping changes to the regulation of the products. Changes to the government's oversight of the tests has generally pitted the clinical lab industry, which supports the status quo, against medical device companies (24 HCDR, 2/5/15).
The Energy and Commerce Committee is planning to mark up a revised version of the draft legislation “in the near future,” a panel spokeswoman told Bloomberg BNA May 5.
Currently, the Centers for Medicare & Medicaid Services regulates laboratory developed tests (LDTs), while the Food and Drug Administration regulates certain in vitro diagnostic tests, or those tests manufactured by device companies. In fall 2014, the FDA issued two controversial draft guidance documents to initiate its own oversight over LDTs.
The draft bill, last circulated by the committee in October 2015, would create a Center for In Vitro Clinical Tests to approve lab tests at the FDA (221 HCDR, 11/17/15).
During a separate FDLI session, Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, reaffirmed that the agency is hoping to release the updated LDT guidances sometime in 2016.
At a November 2015 Energy and Commerce Committee hearing, Shuren said he hoped the final guidance documents would be released earlier in 2016 as opposed to later in the year. However, he has been more vague about when he expects the agency to issue the LDT documents since then.
For example, at a March meeting of a clinical lab industry group, Shuren wouldn't commit to saying when in 2016 he expected the LDT documents to come out and said he isn't in full control of when the documents will be released. The FDA also must be mindful of the end of the Obama administration in January 2017 and the congressional calendar as it considers the LDT documents, he said at the time (43 HCDR, 3/4/16).
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The draft legislation is at http://docs.house.gov/meetings/IF/IF14/20151029/104127/BILLS-114pih-HR____.pdf.
Details about the FDLI conference are at http://www.fdliannual.com/.
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