Dive Brief:
- The FDA is targeting laboratory-developed tests that have not met FDA guidelines which are inaccurate and leading to wrong and potentially harmful medical decisions.
- The agency's report coincides with efforts by both the Obama administration and Congress to set more rigorous standards, which would mark the most significant change in laboratory regulation since 1988, as reported by The New York Times.
- Regulatory guidelines for diagnostic tests vary depending on whether the test will be sold to multiple labs ("commercial test kits") or made and used within a single lab. The former are subject to FDA review, the latter has not been subject to FDA regulatory enforcement.
Dive Insight:
The Obama administration wants to enforce authority over tests manufactured and used by a single laboratory, stating these are more complex, more widely used, and closer to commercial tests the government has regulated for the past 40 years.
Consumer groups and Democrats agree with the push for regulation, but Republicans don't agree on whether a more prominent federal role is necessary.
Rep. John Shimkus (R-IL) said, "This is a tough area for conservative Republicans who think that government is too big and costs too much." But, he said he's willing to consider legislation because federal standards may be required to ensure the tests' accuracy.
However, the Americal Clinical Laboratory Association stands opposed to federal guidelines, stating, "the FDA lacks the statutory authority to regulate laboratory-developed tests."