NCHR Testimony Before the FDA on “Framework for Regulatory Oversight of Laboratory Developed Tests”


Thank you for the opportunity to speak today at this very important meeting.  My name is Dr. Anna Mazzucco, and I am speaking on behalf of the National Center for Health Research.   I received my Ph.D. in cell biology from Harvard Medical School, and I conducted post-doctoral research here at NIH. Our nonprofit organization conducts research, scrutinizes data in the research literature, and then explains the evidence of risks and benefits to patients and providers.  [Our organization does not accept funding from companies that sell medical products, and therefore I have no conflicts of interest.]

I am speaking as a scientist who appreciates the power of data and who also wants patients and physicians to have the best information possible before they make potentially life and death decisions.  The FDA released new guidance on laboratory-developed tests because of evidence that patients are harmed by faulty tests.

We applaud the FDA for their plan to improve oversight of lab tests and the NIH for their commitment to medical care. We have a few key points:

  • Many of these tests are used to diagnose a disease or determine a course of treatment.  If the test doesn’t work correctly, the patient may be exposed to risks from a treatment they didn’t need, OR not receive treatment that would help them.
  • When the FDA started regulating devices almost 40 years ago, these tests were very different.  They are now widespread and are the basis of high-risk decisions.
  • Under CLIA, test makers do not have to demonstrate “clinical validity”.  At FDA, approval standards include safety and effectiveness.  FDA review will improve transparency and data quality.
  • Current policies do not require adverse event reporting or manufacturing safeguards.  FDA approval does.  Patients using high-risk diagnostics deserve those protections.

Our Center has frequently urged the FDA to improve their oversight of medical devices. Despite past criticisms, we believe it is essential that FDA have the authority to regulate laboratory-developed tests in order to stimulate even better science, and help ensure that patients receive the full benefit of our growing scientific knowledge.

To paraphrase Dr. Josh Sharfstein’s JAMA article:

Patients travel in ambulances that are regulated, to hospitals that are regulated, for care using medicines that are regulated, administered by nurses and physicians, who are regulated. That same patient’s life or death should NOT depend on whether an unregulated diagnostic test result is accurate.

Thank you for the opportunity to speak today.