Lab-developed tests: FDA oversight unclear

October 15, 2010

Pharmacies soon may be stocking their shelves with laboratory-developed tests that first require FDA approval.

Key Points

  • FDA held a public meeting titled "Oversight of Laboratory Developed Tests," featuring an overview of the history and current regulatory status of LDTs.
  • Included in the public meeting were 4 sessions intended to provide FDA with testimony on how best to oversee LDTs.
  • These sessions included patient and clinical considerations, clinical laboratory challenges, direct-to-consumer test marketing, and education/outreach.

Pharmacies soon may be stocking their shelves with laboratory-developed tests (LDTs) that first require FDA approval. A recent example illustrates what happened when a major retail chain intended to market home genetic testing kits, a type of LDT. In that instance, the maker of the test kit was the recipient of an FDA intervention when the agency investigated the question of whether the kit might be a "medical device" and therefore subject to FDA regulatory requirements.

The intervention occurred because FDA has now decided that it will exercise its authority to oversee LDTs. However, how such oversight will take place is still unclear. In that connection, on July 19-20, 2010, FDA held a public meeting titled "Oversight of Laboratory Developed Tests," featuring an overview of the history and current regulatory status of LDTs.

Included in the public meeting were 4 sessions intended to provide FDA with testimony on how best to oversee LDTs. These sessions included patient and clinical considerations, clinical laboratory challenges, direct-to-consumer (DTC) test marketing, and education/outreach.

The public meeting came immediately after FDA notified 5 genetic test manufacturers that because their products involve DTC test marketing, the products are medical devices subject to FDA regulatory oversight, including pre-market review.

FDA has subsequently contacted other firms that market LDTs directly to the public. As a result, FDA plans a full-scale review of its current reserved enforcement discretion and will undertake more expansive oversight of LDTs for the first time.

Proper validation needed

FDA is concerned that LDTs that have not been properly validated for their intended use may put patients at risk. These risks might include a missed diagnosis, wrong diagnosis, or failure to receive appropriate treatment. As a result, diagnostics critical for patient care may not be developed in a manner that provides a reasonable assurance of safety and effectiveness.

In addition, FDA recognizes that while absence of FDA oversight may make it easier for laboratories to develop and offer tests on a rapid timeline, the absence of a level playing field discourages innovation by other manufacturers whose tests are approved or cleared by FDA.

Notably, since the implementation of the 1976 Medical Device Amendments, FDA has generally exercised enforcement discretion and not enforced applicable regulations with respect to LDTs, a class of diagnostics that are developed, validated, and offered within a single laboratory. Thus, FDA has not actively regulated most LDTs.

During the public meeting, FDA stated that it would consider all comments presented during the 2-day session, as well as comments submitted to the public docket. FDA stated that it would then develop a defined "framework" of LDT oversight. According to FDA, the framework would then be published for public comment, before the FDA moves forward to finalize it.

Although it is currently unclear what scope of oversight FDA will undertake with respect to LDTs, FDA has stated that it believes a risk-based application of oversight to LDTs is the appropriate approach to achieve the desired public health benefits. The 2-day public meeting was a step toward shaping the scope of oversight that FDA intends to undertake. In any event, at a minimum, the consequences of FDA oversight may subject laboratories to FDA compliance requirements, including the possibility of pre-market review and clearance by FDA authorities prior to market introduction, at least for certain LDTs.

NED MILENKOVICH is a member at McDonald Hopkins, LLC and chairs its Drug & Pharmacy Practice Group. He is also a member of the Illinois State Board of Pharmacy. Ned can be reached at 312-642-1480 or at nmilenkovich@mcdonaldhopkins.com
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