|
Can FDA Approval Be Reversed by Public Opinion?
(Thursday, April 11, 2024) A genetic diagnostic test approved by the FDA has come under surprisingly strong criticism by researchers, physicians, and some public interest groups, so much so that they have petitioned the FDA to revoke its approval and that CMS should not cover it. But would the FDA rescind a test it approved based on non-FDA research and concerns from independent groups? There is no precedence for this and there are good reasons for that. Last December, the FDA approved the first genetic test intended to diagnose people with a higher risk of developing opioid use disorder (OUD). The test is recommended before a 4–30-day prescription of oral opioid pain medications. Such prescriptions are common for acute pain management in patients scheduled to undergo a planned surgical procedure. Per the FDA announcement, the test is to be used as a part of the complete clinical evaluation and risk assessment and not to be used alone to make treatment decisions or for patients needing chronic pain management. The test was approved under the De Novo 510k regulatory pathway whereby the developer presented clinical trial data along with other supporting evidence. Like all diagnostic tests, the test carries the risk of false positive and negative results and hence must be used in conjunction with other information available for a given patient before a decision is made to use/not use prescription opioid pain medications. According to the FDA, such tests are needed as a tool to prevent opioid overdose. The physician groups and researchers strongly disagree with the FDA. They are concerned that a genetic test is not a reliable tool with a rate of 18.2% false-negative and 20.8% false-positive, as published. They are concerned that relying on this test exposes prescribers to higher liability as patients may not understand the true intent of the test which is a supportive and not definitive diagnosis of the likelihood of OUD. The test was rejected by the FDA Advisory Committee convened to review the test prior to approval and got negative comments at an FDA public workshop to consider developing such tools. The company promised to start with a slow roll-out of the test whereby it would make the test available to a select group of trained clinicians to access how the test would be used in clinical practice before wide launch. The complainants of the approval are not impressed. So far, the FDA has rejected the plea to rescind its approval and it does not appear that CMS, or any other government agencies that might pay for the test, has expressed any concerns with the use of the test. This is an opportunity to explore the utility of such tools and should not be curtailed by theoretical concerns by independent parties. The FDA should let the test play out during the initial slow roll-out. It is critical to emphasize that this is one of the tools available to physicians when making prescription decisions and should be used along with the other tools they have available to them as well. This would be a good test (no pun intended) of the role of physicians and public education in using such diagnostics and could help pave the way for or curtail other genetic tests designed to diagnose indications traditionally believed to be behavioral traits. 
AUTHOR
Dr. Mukesh Kumar Founder & CEO, FDAMap Email: [email protected] Linkedin: Mukesh Kumar, PhD, RAC Instagram: mukeshkumarrac Twitter: @FDA_MAP Youtube: MukeshKumarFDAMap |
|
|
|
