Washington D.C. – Cause of Action Institute (“CoA Institute”) today sent a Freedom of Information Act (“FOIA”) request to the Food and Drug Administration (“FDA”) to examine its role in regulating laboratory developed tests (“LDTs”), including tests for the Zika virus. This investigation comes on the heels of the FDA’s post-election decision to indefinitely postpone guidance documents the FDA had issued in an attempt to regulate LDTs.
This year, the FDA took steps to enforce its guidance against labs that had developed Zika tests. The FDA’s actions would further limit patients’ access to testing for the Zika virus, which can cause serious birth defects. The FDA and the Centers for Disease Control and Prevention (“CDC”) have already put in place a policy limiting the availability of Zika tests to only pregnant women and individuals who were exposed to Zika and are experiencing symptoms. In other words, unless pregnant, an asymptomatic person who has traveled to a country with known Zika transmission prohibited from being tested for the virus. This policy prevents couples who are trying to conceive from information that would help them make personal healthcare and family planning decisions.
CoA Institute Vice President John Vecchione: “The FDA needs to explain its actions. After 40 years of allowing laboratories to innovate freely and offer patients a variety of tests that often meet unique healthcare needs, it is troubling that the FDA has chosen to crack down just as the Zika virus started to spread. Couples exposed to Zika who are trying to conceive should not have to face bureaucratic hurdles to obtain testing. Instead, they and their doctor should have access to testing services that meet their unique needs. Such decisions cannot be made at a bureaucracy’s pace.”
Due to the rapid onset and spread of the Zika virus, there is still no test that has undergone the FDA approval process for in vitro laboratory developed tests (meaning laboratory tests performed in a test tube, culture dish, or elsewhere outside a living organism). Rather, the Zika tests currently available for use were all approved by the FDA pursuant to an “Emergency Use Authorization,” which comes with strict limitations.
Clinical laboratories that perform testing services were historically regulated solely by the Centers for Medicare and Medicaid Services. However, beginning in 2014, the FDA asserted that it, too, has regulatory authority over laboratory developed tests. The FDA has authority to regulate manufactured drugs and “medical devices” pursuant to the Federal Food, Drug, and Cosmetic Act. In 2014, the FDA issued draft guidance documents that assert sweeping authority to treat laboratory developed tests as “medical devices.” Accordingly, the FDA asserted authority to regulate LDTs as “medical devices” under this updated guidance.
In addition to a CDC-developed test, private laboratory companies have developed Zika tests and obtained approval to administer the tests pursuant to the Emergency Use Authorization. However, even these tests developed by private companies are subject to the CDC’s policy limiting the test to pregnant women or symptomatic individuals who were exposed to Zika.
CoA Institute is interested in learning more about the FDA’s attempts to regulate these tests and the impacts such regulation may have on the ability of patients and doctors to access testing services.
The full FOIA is available here