For over a century, the U.S. Food and Drug Administration (FDA) has done a laudable job of ensuring the safety and efficacy of healthcare for Americans. Recently announced potential policy changes, however, have a good chance of doing just the opposite.
Most of us give little thought to what goes on behind the scenes when our doctors order medical tests. We have blood drawn and wait for results, never hearing about the tremendous amount of innovation that has taken place in the medical diagnostics arena. Precision testing, particularly tests based on DNA, is leading to more personalized care – and fewer wasted health care dollars – for those with cancer, AIDS, and a host of other conditions. For people with rare disorders, sensitive new tests are especially critical – there is no pain like that of watching a child with a complex disease go undiagnosed and untreated.
The FDA is now proposing a new level of regulation over diagnostic tests that will stifle innovation and is likely to make tests for some conditions completely unavailable. In particular, many tests for rare disorders would never come to light because the market for them is not large enough to support commercial development and production.
Many newer diagnostic tests are being developed and validated within sophisticated clinical labs themselves, rather than purchased from a manufacturer. To date, the FDA has openly opted for a policy of "enforcement discretion," choosing not to apply its presumed authority over these tests, and allowing the labs to select the components and to design and validate their own tests. Accuracy and safety of diagnostic tests is, of course, paramount, and clinical labs are regulated by federal and state agencies, including the Centers for Medicare and Medicaid Services. In addition, professional societies, such as the College of American Pathologists and COLA (formerly Coalition of Office Lab Accreditation), constantly monitor and assess the quality and proficiency of clinical labs and the accuracy of their data. As a result, millions of tests are run each day in the U.S., crucial information is delivered to ordering physicians, and countless lives are saved. There is no evidence that this system does anything but care wonderfully for the patients its serves.
In fact, the evidence indicates that testing quality has steadily improved. Newer DNA tests for HIV, for example, are more accurate and quantitative than ever, allowing physicians to fine-tune drug regimens and improve their patients’ lives. Research in academic and medical center labs has demonstrated the complexity of cancer, showing us that tumors with similar appearance by traditional microscope methods can be very different if we peer further within, to the gene level. Tests for cancer-promoting genes are becoming increasingly available, and are being used to steer patients toward effective treatments targeting the specific genetic errors present in their disease.
The current system saves both lives and dollars. In addition to delivering routine clinical care, hospitals and testing laboratories often conduct basic and clinical research. Labs have been able to purchase one set of equipment to service all three endeavors while carefully monitoring the quality of the data they deliver. Not having to buy equipment for research and then another set for clinical work has saved these institutions from excessive capital costs, costs that would have to be passed on to insurers and patients.
FDA is now proposing to change their approach to these tests, and restrict their use, depriving patients of critical diagnostics just at the time when the dream of personalized medicine is becoming a reality. Moreover, the agency would force manufacturers into the role of policing their customers, which is burdensome and unnecessary.
The FDA’s proposed change towards more enforcement will only harm a well functioning system and the many needy patients who will find it harder or more expensive to obtain the clinical tests their doctors deem necessary. Patients with rare disorders often pursue a correct diagnosis for years – ten to fifteen years of searching is not uncommon. Must we add to their burden?
FDA’s "non-enforcement" era in diagnostics has been a great success, and it is in Americans’ best interest for it to continue.