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EDITOR'S PAGE

Senator Edward M. Kennedy (D–MA) recently announced that in the coming months, he plans to introduce a bill on laboratory-developed tests that he hopes to move through Congress next year. Kennedy’s legislation intends to clarify that FDA has authority to regulate home-brew tests and to provide direction to the agency about how to exercise that authority.

“Doctors and patients are making important medical decisions based on the results of clinical laboratory tests,” said Kennedy. “We need to ensure that they understand the clinical significance of the results, and are confident that the tests are accurately performed. My bill will focus the Congress and others on the need for an important role for FDA in this area.”

In essence, Kennedy’s bill would establish once and for all that FDA is responsible for overseeing home-brew tests. Such a proposal has been needed for a long time, and would undoubtedly offer a variety of long-term benefits to IVD manufacturers. Nevertheless, because of the scope and complexity of the issues involved, the senator’s legislation will face a steep uphill climb toward passage.

FDA and CMS have been wrangling over how to regulate home-brew tests for many years, with little success or resolution. A major problem stems from the fact that neither of these agencies has the proper financial and personnel resources to regulate every lab that develops home-brew tests. Consequently, home brews have been allowed to propagate without direct regulation, subject only to the indirect requirements imposed on laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). And even though FDA has maintained its authority over home brews and has made some effort to stay involved by regulating ASRs, the agency has also ceded much of its regulatory authority over home-brew tests to CMS. Meanwhile, CMS has not followed through on providing greater regulation of home brews by developing a genetic testing specialty under CLIA.

There are a lot of steps to be taken before Senator Kennedy’s proposed legislation can be written, debated, amended, and enacted into law. Before and afterward, there will no doubt continue to be conflicting opinions about what the regulations for home-brew tests should be and what agency should be responsible for overseeing and enforcing them. While writing and debating this legislation, Kennedy and his colleagues will need as much guidance and expert advice on home brews as possible. While the Senate may ask the relevant government officials for their thoughts, it is imperative for the IVD industry to get involved by providing its input on this proposed legislation.