Replies to Changes in the Diagnostic Regulations
Ariella Jaffe response:
If I were the Head of the Food and Drug Administration (FDA), I would make a few changes in the way diagnostic regulations are drafted and carried out. To begin with I would combine the two major systems of regulations for diagnostic tests into one united system. Currently, diagnostic tests in the U.S. are regulated under two major rule sets depending on the diagnostic; laboratories that develop in-lab diagnostic tests can be licensed under the Clinical Laboratory Improvement Amendments (CLIA) and are free from direct FDA regulation, whereas diagnostic medical devices are regulated directly by the FDA (Goulazian, 2020). Unfortunately, there is significant overlap between in-lab testing and medical devices, and the FDA effectively gets to cherry pick which cases they would have direct oversite over, and which would default to CLIA regulations (Goulazian, 2020). This can be seen in the U.S. response to the Covid 19 pandemic, where the FDA took over responsibility for authorizing Covid-19 testing, even from CLIA licensed labs (Goulazian, 2020). The Verifying Accurate Leading-edge IVCT Development Act (VALID act), introduced to congress in March of 2020, attempts to clarify who regulates various diagnostic testing (Goulazian, 2020); under my leadership in the FDA, rather than clarifying between the two systems of regulations laid out in the VALID act, I would bring both systems under one umbrella. Secondly, I would invite industry experts to participate in writing and overhaling the current diagnostic regulation system. The current diagnostic regulation system is disjointed, an example of which is can be seen in the development of a Covid 19 diagnostic test, where the FDA gave the Centers for Disease Control (CDC) the exclusive authority to develop a test, effectively slowing down development of a Covid 19 diagnostic test by creating an artificial monopoly (Goulazian, 2020). Because of this, I think it is important to include industry leaders and experts in the drafting and implementation of regulations. These are the people who truly know the ins and outs of the regulatory system, and what kind of regulatory oversight would be most effective. This could re-design the way diagnostics are regulated according to the actual process from the perspective of the people who develop these tests.
Ariella response:
Thank you for this intriguing post. I also mentioned in my post that I’d advocate having a parallel reviewing program (a one that includes both CLIA & FDA) for regulating a proper regulations for diagnostic tests, as the VALID act can result in giving the FDA enough authority to create more monopolies on diagnostic tests by preventing CLIA- licensed labs from refining tests (Shirts, 2020).Therefore by this approach the FDA would slow the process of innovation at a time when rapid innovation is critically important, that in turn will lead to higher costs and periodic shortages of diagnostic tests for diseases such as COVID-19 (Shirts, 2020). It’s worth mentioning that the VALID act was created because large pharmaceuticals companies wanted to have monopolies on cancer tests (Shirts, 2020). This will certainly affect testing for diseases such as cancer and inflammatory bowel disease, so if VALID act passes, there will be shortages in these diagnostic tests (Shirts, 2020). A parallel reviewing program was shown to be very successful before and should be used, for example, the one that includes (FDA & CMS), which decreases the time between FDA’s approval of a premarket application and the subsequent CMS national coverage determination (NCD)(FDA, 2020). That will allow both of them to review information about a medical device concurrently, where FDA ensure that the medical devices are safe and effective while CMS ensures medical devices are medically reasonable and necessary in order to be covered (kux & Slavitt, 2016).
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