TRENDS & PERSPECTIVES
Senator Edward M. Kennedy (D-MA) introduced the Laboratory Test Improvement Act (S. 736), which is intended to grant FDA the authority to regulate laboratory-developed tests. This bill has been referred to the Senate Committee on Health, Education, Labor, and Pensions, which is chaired by Kennedy.
The legislation will require labs providing home-brew tests to submit evidence to FDA that supports their analytical and clinical validity. All the information submitted to FDA will be compiled into a database, which will subsequently be made available to the public on the Internet. Under specific circumstances, the bill allows FDA to require home brews to go through the 510(k) or PMA process, after giving labs the opportunity to correct the information. Such circumstances include if the information on the test in the database is inadequate, if it shows the test is not comparable to an FDA-approved test kit, or if the test is a direct-to-consumer test.
Labeling for home-brew tests would also have to indicate whether they have not been approved by FDA, and healthcare providers and patients will receive results noting such information.
Even though the bill appears to level the playing field by making labs as accountable as IVD manufacturers, some industry analysts believe the proposed review framework for home-brew tests would place enormous burdens on FDA.
“The bill would impose significant new responsibilities for the Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD), but without giving it new resources,” says Jeffrey N. Gibbs, JD, director at Hyman, Phelps & McNamara (Washington, DC). “The extra workload from home brews will detract from OIVD’s ability to review submissions. The bill will also impose new costs on laboratories, hurting the IVD industry’s customers. In addition, the bill will create significant confusion due to the ambiguous language and provisions, which cannot benefit the industry.”
Other analysts believe that if labs developing home brews decide to discontinue doing so because of the increased regulation, cutting-edge tests for certain rare diseases will no longer be available.
The Kennedy bill drastically upsets the playing field such that the effect could be the end of innovative home-brew tests, which will be detrimental to public health,” says Thomas M. Tsakeris, president of Devices and Diagnostics Consulting Group Inc. (Rockville, MD).
