On November 17, 2015, the House Energy & Commerce Subcommittee on Health held a hearing examining the regulation of laboratory developed tests (LDTs).  CMS Deputy Administrator Patrick Conway and CDRH Director Jeffrey Shuren testified regarding the respective roles of CMS and FDA in the oversight of LDTs.

The day before the hearing, FDA issued a report of 20 case studies that FDA provided in support of its proposal to regulate LDTs as devices.  FDA describes this report as illustrating “how lack of LDT oversight may be causing or is causing significant harm to patients.”

As previously reported, last October FDA published a draft guidance document describing its proposed new regulatory framework for oversight of LDTs (and a companion draft guidance document on notification and reporting for LDTs).  Publication of the draft guidance documents followed a statutorily-required 60-day notice to Congress.  At the recent hearing, Dr. Shuren stated that FDA hopes to finalize the guidance documents in 2016.

At the hearing, the FDA and CMS officials supported FDA’s proposed framework over proposals that have been recommended by various stakeholders.  They stated that, between the two agencies, only FDA had the appropriate expertise to provide premarket review of LDTs and to assess clinical validity.

In the year since publication of the draft guidance documents, the appropriate framework for oversight of LDTs, and the question of whether FDA has authority to regulate LDTs, has been the subject of significant debate.  For example:

  • In September 2014, during the 60-day notice period, the Health Subcommittee of the House Energy and Commerce Committee held a hearing on FDA’s draft guidance documents.
  • In November 2014, a coalition of nearly 40 laboratories, medical groups and other organizations sent a letter to FDA asking the agency to withdraw the draft guidance documents and use formal rulemaking.
  • In December 2014, the House Energy and Commerce Committee issued a white paper seeking feedback on eleven questions regarding oversight of LDTs as part of the 21st Century Cures initiative.
  • In January 2015, FDA held a two-day public workshop on the agency’s proposed framework for oversight of LDTs, at which numerous stakeholders presented differing views.
  • The same month, the American Clinical Laboratory Association released a white paper arguing that FDA lacks the authority to regulate LDTs as medical devices.
  • Over 200 comments were submitted to the docket for FDA’s draft guidance documents prior to the close of the comment period in February 2015.
  • In April 2015, in a FDAVoice blog post, FDA announced that FDA and CMS formed a task force on LDT quality requirements.
  • Also in April, the Diagnostic Test Working Group, a coalition of certain diagnostic manufacturers and clinical laboratories, released an alternative framework under which all in vitro clinical tests, including LDTs, would be regulated separately from medical devices with jurisdiction shared between FDA and CMS.
  • In June 2015, the House Energy and Commerce Committee circulated a draft bill that would establish a new statutory framework for the regulation of in vitro clinical tests, including LDTs, by a new FDA Center for In Vitro Clinical Tests.
  • In August 2015, the Association of Molecular Pathology announced that it had met with the Senate Health, Education, Labor and Pensions Committee to discuss a proposal for modernization of CLIA regulations for LDTs.
  • In September 2015, the College of American Pathologists released a legislative proposal that would primarily involve modifications to CLIA but would include FDA regulation of high-risk LDTs.
  • In October 2015, the House Energy and Commerce Committee circulated an updated draft bill (revising the draft bill first circulated in June).
  • Also last month, a coalition of eight organizations sent a letter to the Senate Committee on Health, Education, Labor and Pensions in support of modernizing oversight of LDTs though reform of CLIA.

We will continue to monitor and report on developments in this area.