On LDTs, FDA Punts it Back to Patients and Panders the Politicians
(Thursday, April 21, 2022)
This week FDA released a public warning about Lab Developed Tests (LDTs), specifically non-invasive prenatal screening (NIPS) tests, which puts the responsibility on the patients to verify the reliability of these tests while making statements that could be seen as pandering to the concerns of conservative politicians who objected to NIPS tests on religious grounds. NIPS are popular tests conducted to determine if a fetus has genetic abnormality, presence of which could, in turn, influence a decision to terminate the pregnancy. Hence, many anti-abortion activists oppose these tests on religious grounds. In early March, a group of about 100 Republican Congressmen and Congresswomen wrote a letter to FDA asking to regulate NIPS tests. At that time, FDA responded its inability to do so owing to the lack of laws to regulate for LDTs. FDA has long maintained that it can regulate LDTS and that the LDTs are subject to regulatory discretion but each attempt by FDA to create regulatory processes for LDTs over the last decade or so has failed due to strong public support for LDTs, and political head winds. LDTs are a very critical, albeit subjective, resource for physicians and patients to diagnose indications for which FDA-approved tests are not available. LDTs require a doctor’s supervision and cannot be sold directly to patients. So, a medical consultation is an integral part of the use of LDTs. Here comes the NIPS tests. FDA’s public announcement regarding NIPS uses several ambiguous terms which could confuse the public and may actually have the opposite effect on the users. FDA says that such tests “may have” false results, and that additional testing required to confirm the results of a NIPS test, “carry a small risk of miscarriage”, and present the futility of the NIPS tests as neither a positive or negative result could be confirmed, and that “genetic abnormalities are so rare that” the NIPS tests are more likely to give false rather than accurate results. The language can be interpreted as that even the FDA does not know if these tests are totally bogus or just that FDA is not sure, so patients should listen to the prescribing doctors rather than FDA. From a practical point of view, patients using NIPS tests would only do these tests on the recommendation of their physicians. Once the test indicates genetic abnormality, additional invasive tests that carry a risk of miscarriage could be less appealing to the patient. The FDA announcement presents the scenario of an erroneous outcome owing to the unreliable tests but does not present a viable alternative to the patients. It will further confuse a pregnant women worried about the health of her fetus. At the same time, the announcement contains language about accidental termination of a pregnancy which seems to be similar language as in the letter from the politicians. The main purpose of the public announcement seems to be to pander to the politicians who object to NIPS probably to get political support for the wider regulation for all LDTs. This announcement will be used by those opposed to all abortions but will it help FDA finally regulate the LDTs? Time will tell.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC