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LDT Regulation: The Plot Thickens

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There have been some interesting developments over the last few weeks in the ongoing discussion about FDA’s desire to regulate LDTs.

Pathologists Still Oppose Regulation
At the annual meeting Nov. 12-14 of the Association for Molecular Pathology (AMP) a special late-breaking “Conversations with the FDA” session was held to discuss FDA’s proposed regulation. AMP took the opportunity to reaffirm its position that LDTs are properly overseen by CLIA, and in fact reminded everyone that its term “Laboratory Developed Procedures”, or LDPs, more accurately describes the testing being done by CLIA labs.

Multiple Stakeholders Ask FDA to Withdraw Its Draft Guidances in Letter to Margaret Hamburg
From the Nov. 18 letter:
On behalf of the undersigned organizations, which represent a broad and diverse array of stakeholders including, but not limited to, hospitals, clinical laboratories, physicians, other health care providers and industry involved in delivering medical care to millions of patients daily, we are writing to request that the Food and Drug Administration (FDA) withdraw the proposed draft guidance, “Framework for Regulatory Oversight of Laboratory Developed Tests” and associated guidance.

Multiple Groups Support Regulation During Roundtable Discussion
From the Nov. 18 press release:
The American Cancer Society Cancer Action Network, the American Heart Association, and the Ovarian Cancer National Alliance, in cooperation with Rep. Louise M. Slaughter (D-NY), held a roundtable discussion on the Food and Drug Administration’s (FDA) draft regulatory framework for Laboratory Developed Tests (LDTs). The panel of doctors, scientists, and academics discussed their support for increased FDA oversight over LDTs to provide more accurate, effective care to patients.

Clinical Labs Are Girding for a Fight
The American Clinical Laboratory Association (ACLA), the largest trade organization for clinical labs, announced on Nov. 18 that it has retained “two of the nation’s most preeminent experts in constitutional law and administrative procedure [Paul D. Clement and Laurence H. Tribe] to advise ACLA in its opposition to the FDA proposal.” ACLA stated in its announcement that the very fact that Clement and Tribe decided to take the case was a validation of its merits.

FDA Schedules Public Hearing on Draft Guidances
The Agency has just announced the agenda for a two-day public hearing, Jan. 8 & 9, covering six topics related to its draft guidances.

The six topics are:
– Components of a Test and LDT Labeling Considerations
– Clinical Validity/Intended Use
– Categories for Continued Enforcement Discretion
– Notification and Adverse Event Reporting
– Public Process for Classification and Prioritization
– Quality System Regulation

Editorial: Safety Claims Still Get Minimal Substantiation
On October 23, FDA hosted a webinar during which its draft Guidance Documents were reviewed, and questions from viewers answered. During this webinar the FDA panelists were asked for examples of “bad” LDTs, and once again trotted out the six-year old example of Ovasure, which of course is the one example that the agency uses repeatedly, and which I have argued could be looked at as an example of existing peer review regulatory systems working as they should. The panelists also pointed to a false whooping cough outbreak which caused some people to receive antibiotics unnecessarily, in part due to an LDT, and a New York Times article about Vitamin D testing. The panelists said that the Agency has received information about other “bad” LDTs which it it unable to disclose.

Given the massive impact that FDA regulation is poised to have on the LDT industry, it seems appropriate that FDA provide a much stronger record in support of its claim that LDT regulation will improve public safety.