Last year, the Food and Drug Administration (FDA) and various groups sought to pass legislation, the Verifying Accurate Leading-edge IVCT Development (VALID) Act, which would have extended agency oversight to laboratory developed tests (LDTs). The Association for Diagnostics & Laboratory Medicine (ADLM) and its allies succeeded in preventing passage of the bill.
Since then, the FDA has stated that it will use its regulatory authority to oversee LDTs. To that end, the agency submitted a proposed rule to the White House Office of Management and Budget (OMB) for review, which would do just that. Before the proposal can been published, the government agency must review it to ensure that it complies with existing federal laws.
On September 7, ADLM met with OMB staff to raise procedural concerns about the proposal. Additionally, in a letter to OMB, the association identified several areas of concern, such as:
- the lack of clarity regarding FDA’s legal authority to regulate LDTs;
- concerns about whether the agency has the resources to implement the proposal;
- the significant administrative burden that would be placed on academic medical centers, commercial laboratories, and small community hospitals;
- its adverse effect on access to quality, timely care in medically underserved communities;
- the existing regulatory process already in place for overseeing LDTs; and
- the lack of a regulatory impact/cost-benefit analysis of the proposed rule.
Should OMB approve FDA's proposed rule on LDTs, the public will have 60 days to provide comments on the document. ADLM will provide comments as well as urge its members to do so as well.
While the VALID Act's future appears uncertain, ADLM remains focused on the threat posed by the FDA's rulemaking process regarding regulation of LDTs. The association will continue to advocate for a regulatory landscape where laboratories can continue to perform safe, high-quality, innovative testing for their patients.