Healthcare / Regulation

FDA Plans to Regulate LDTs

The U.S. Food and Drug Administration (FDA) decision to regulate laboratory diagnostic tests (LDTs) is gaining momentum, but also facing much criticism.   The FDA recently informed Congress of their intent to regulate LDTs, which previously did not require FDA approval. The FDA has yet to release their draft guidance documents, but they are on track to make public their proposal after the 60-day Congressional notification period.

At a hearing this week, members of the U.S. House of Representative Energy and Commerce Committee’s health subcommittee met to discuss the implications FDA regulation would have on the diagnostic industry. While the FDA’s new stance has been met with mixed reactions, the difficult part is identifying the middle ground between too little regulation and too much regulation.

The FDA has had the authority since 1976 to regulate LDTs, but they have not enforced laboratories to seek their approval when manufacturing tests. Instead, the FDA currently practices “enforcement discretion” and LDTs are regulated by the Centers for Medicare and Medicaid Services through the 1988 Clinical Laboratory Improvement Amendments (CLIA). While CLIA already enforces labs to conduct their tests properly and under code, the FDA argues that CLIA does not determine the clinical validity of the test itself. For example, CLIA does not answer how precisely LDT’s measure a patient’s condition. The FDA plans to eradicate these problems through greater regulatory inspection.

The FDA’s regulatory influence would not extend to all LDTs. The FDA would continue to exercise enforcement discretion on LDTs that the FDA considers low-risk, tests that diagnose rare diseases, and those that have no FDA approved counterpart. For the tests that do not fit into these criteria, labs would have to deliver data proving validity to the FDA. However, it remains unclear how many laboratories would have to follow these new enforcements. This leads to another criticism that the FDA’s proposed framework for involvement currently remains vague.

Public opinion is divided about the FDA’s role in regulation of LDTs. Many opponents have an aversion to increased FDA involvement, including lawmakers and stakeholders. Major questions about FDA regulation inhibiting innovation will be raised over the next few months, and the FDA’s authority to regulate will be confronted. Alan Mertz, president of ACLA and an open opponent to this new regulation, stated that LDTs are services to patients instead of “devices” and the FDA should have no influence.

However, proponents of FDA regulation highlight the importance of the safety of patients in terms of LDTs. FDA Commissioner Margaret A. Hamburg, M.D. reiterated the significance of making sure that “doctors and patients have access to safe, accurate, and reliable diagnostic tests to help guide treatment decisions.” Doctors such as Christopher Newton-Cheh, a cardiologist at Massachussetts General Hospital in Boston, spoke in favor of greater FDA regulation at the hearing claiming that “this is the right thing to do for patients.” He addressed that with the current system, doctors are often unaware if their tests are FDA-approved, and inaccurate results from tests could increase the likelihood of patients undergoing unnecessary treatments or being excluded from a treatment based on inaccurate results.

Despite the public divide, an undeniable benefit can be seen through the strides LDTs are making in medical advancement and the role they will greatly play in personalized medicine. As genetics and patient lifestyle become combined in future treatments and cures, medicine will move away from “one-size-fits-all” treatments to more individualized and targeted medicines.

The good news, to the credit of the FDA, is that they already recognize this and are on top of it. However, FDA involvement may not be as black and white as many lawmakers may like. The underlying complexity lies in finding a balance between too much regulation, where it would be too hard and expensive to develop new tests due to too much oversight, and too little regulation, where the accuracy and reliability of new tests is questionable.

Thus as of now, it appears that the intentions of the FDA are good, but unfortunately good intentions hardly guarantee good results. The challenge the FDA will have over the next few months is making sure they give a step-by-step proposal of how they plan to implement regulation.

For example, how will the FDA determine low-risk, moderate risk, and high-risk LDTs? Do breast cancer susceptibility tests categorize as moderate or high risk? While these may on the surface seem to be high risk, they may not garner immediate medical attention and treatment or surgery may be unnecessary. For example a woman with a BRCA1 mutation has a 50-70% chance of developing breast cancer up to the age of 70. A young woman in her 20s may classify this as a moderate risk and start mammograms at an earlier age, while a woman in her 50s may be more likely to view this as a high risk. The FDA’s task is to set definitions of risk assessment, but with such a diverse population, it is certainly proving difficult.

The FDA needs to establish a regulatory language that does not leave so much up to interpretation. I commend the FDA for stepping in to address a topic that has needed to be addressed ever since the 23andMe lawsuit of last year, but I am sympathetic to the challenges and difficulties they face in implementing regulation and policy of a constantly and rapidly evolving field.