How many health-related lab tests did you have in the last year? You probably did not give much thought to how these tests were regulated. Well, how tests are regulated may be about to change and this may have major impact on you. The U.S. Food and Drug Administration (FDA) is moving to take over control of laboratory-developed tests (LDTs). The range of arguments for and against this change is extensive, complicated, and confusing to follow.
Currently LDTs are tests developed by a local lab for a local population. These for some time have been controlled by the U.S. Centers for Medicare and Medicaid Services. Shifting these LDTs to be under the FDA will shake things up big time. Implementation could be gradual and have many exceptions, but what will really happen has not yet been clarified.
Supporters list benefits as improved accuracy and clinical validity of the tests. Those opposing express concerns that meeting FDA requirements will result in higher testing prices, and testing standardization will stifle vital customization and innovation. Further, that many important tests will disappear because of the inability to cover the cost of expensive required clinical trials.
Issue: FDA fully controlling lab tests
AHHA strives to maintain a neutral position on issues. To support those of you who wish to figure out what this month’s issue is really about, we have compiled the following pro and con online articles to get you started.
PRO (supporting FDA control of LDTs)
Pro Link #1: F.D.A. Acts on Lab Tests Developed In-House (7/31/14)
by Andrew Pollack
The New York Times
Pro Link #2: In Major Shift, FDA to Regulate Lab-Developed Tests as Normal Devices (8/1/14)
Regulatory Affairs Professionals Society
Pro Link #3: FDA Commissioner Calls for More Active FDA Regulation of Laboratory-Developed Tests, and ACLA Promptly Responds with a Petition Opposing FDA (6/5/13)
by Jeffrey N. Gibbs, Jamie K. Wolszon & Jessica A. Ritsick
FDA/ Law Blog
CON (against FDA control of LDTs)
Con Link #1: What You Need to Know About the FDA’s Push to Regulate Laboratory Developed Tests (8/1/14)
by Aaron Krol
Bio IT World
Con Link #2: What If the Government Standardized All Medical Testing? (7/15/14)
Alliance for Natural Health USA
Con Link #3: ACLA Expresses Concern with FDA Guidance on Laboratory Developed Tests (LDTs) (7/31/14)
American Clinical Laboratory Association
We encourage you to post your comments and tell your friends about additional resources you have found relating to this important health issue.