As reported in Biopharma Dive, the FDA’s decision to strengthen its authority involving laboratory developed tests (LDTs) has drawn considerable objections from various healthcare groups. However, the Agency has held steadfast in its determination to protect patients against what it describes as risks related to LDTs. It is the opinion of the FDA that these risks have increased in concert with the complexity of the tests, requiring closer scrutiny to safeguard patients and ensure accuracy. Therefore, the FDA released a final rule that strengthens its authority associated with LTDs, while at the same time drawing strong opposition from industry healthcare groups.

Amending Agency Regulations

The rule amends the FDA Improvements Act of 1988 regarding in vitro diagnostics that have been manufactured in a laboratory. The FDA is phasing out an enforcement discretion ruling for LDTs to cover any in vitro diagnostic that is manufactured by a laboratory. Thereafter, all LDTs will be regulated by the same enforcement policy.

The Opposition

Opposing views criticize the FDA’s plan, saying it will slow diagnostic development. The new rule classifies the majority of LDTs as medical devices. The new LDTs would be subjected to pre-market review, making them more expensive and taking longer to process. The FDA claims that risks relating to LDTs have increased and the tests are more complex. This requires increased scrutiny to ensure accuracy and safeguard patients. Jeff Shuren, who is the director of the FDA’s Center for Radiological Health and Devices says that the action by the FDA is a crucial step in its effort to provide patients access to critical tests.

LDTs are used in newborn screening, diagnosing Alzheimer’s and heart disease, and predicting a person’s risk of cancer. FDA Commissioner Robert Califf stated that the FDA must take an active part in assuring Americans that the tests are accurate. Opposition to the FDA rule has been spearheaded by the American Clinical Laboratory Association (ACLA), which maintains LDTs should not be classified as medical devices, nor should they be subjected to its regulations. Doing so, according to the ACLA will restrict patient access to testing and discourage innovations that drive personalized medicine.

Susan Van Meter, ACLA President, issued a statement saying that the new rule will diminish access to many crucial tests, add to health care costs and discourage innovation to develop new diagnostics

You can read more about this issue over at Biopharma Dive.