FDA Rejects Requests to Extend LDT Proposed Rule Comment Period

ASCP Releasing Action Alert to Push Back

On Oct. 30, the U.S. Food and Drug Administration (FDA) rejected requests from ASCP and others seeking an extension of the 60-day comment period on the agency’s proposed rule claiming oversight of laboratory developed tests (LDTs). The American College of Medical Genetics and Genomics, the Association for the Advancement of Blood & Biotherapies, the College of American Pathologists, and the Association for Molecular Pathology also requested the FDA extend the comment period on the LDT proposed rule. The FDA defines LDTs as “in vitro diagnostic products that are intended for clinical use and are designed, manufactured, and used within a single clinical laboratory.”

In its comments asking for an extension, ASCP argued that the complexity of the FDA proposed rule, coupled with the short comment period, could undermine the ability of the laboratory community to provide appropriate comments. This increases the possibility that the FDA may adopt an oversight scheme that could interfere with the ability of clinical laboratories to develop and/or provide LDTs for their patients.

LDTs are essential to the diagnosis and treatment of numerous diseases and conditions and are critical to quality care. Laboratories develop LDTs when no suitable commercial (i.e., FDA approved) test is available. LDTs are frequently used for patients suffering from certain infectious diseases, cancers, or rare diseases. For infectious diseases (and public health emergencies like COVID-19), LDTs frequently represent the first quality diagnostics available. Moreover, certain cancers, including pediatric cancers (such as pediatric acute leukemia), may not be diagnosable with commercial test kits. LDTs also include commercial tests that have been modified either because a laboratory has found ways to improve the test or because the requisite testing supplies are not available (as was often the case during COVID-19 pandemic).

ASCP is releasing an Action Alert shortly urging all its members to send the FDA the message that it should extend the rule’s comment period.  To access ASCP’s action alert, click here.

While ASCP believes the FDA should have a role in the oversight of LDTs, the Society also feels strongly that it should be a smaller role than that proposed by FDA. To move forward with the proposal as-is would stifle innovation in the medical laboratory, but more importantly, it would inhibit the provision of care to the detriment of the patient. It is imperative for patients everywhere that the FDA’s proposed rule be recrafted in such a way that it can provide appropriate and reasonable quality standards without undermining diagnostic innovation and/or subverting access to the essential testing services patients may need.

ASCP is continuing its efforts to secure an extension of the comment period and will also be submitting formal comments on the proposed rule. ASCP will also urge members to comment on the proposed rule via an upcoming Action Alert.

To read more articles from this issue of ePolicy, click here. To learn more about ePolicy News and access past newsletters and articles, click here.

For more information regarding ASCP's advocacy initiatives and policy positions, please contact ASCP's Center for Public Policy at (202) 408-1110.