NE Washington News

House Energy and Commerce Committee Chair Cathy McMorris Rodgers expressed her concerns at a Health Subcommittee hearing regarding the FDA's proposed rule that could impact access to reliable diagnostic tests, particularly for children and patients with rare diseases.

Rodgers highlighted the importance of innovation in biomedical technology and the challenges faced by regulatory and reimbursement obstacles that hinder patient access to care. She criticized the FDA for failing to recognize the vital role of laboratory testing and its impact on patients, doctors, and caretakers.

Regarding the FDA's proposed rule on diagnostic tests, Rodgers raised alarm about the burden it would impose on laboratories, especially those offering laboratory developed tests (LDTs). She emphasized the significant costs and administrative hurdles that labs would face to comply with the new regulations, potentially leading to financial strain and limited resources.

Rodgers pointed out the potential consequences of the rule, including fewer diagnoses, higher costs, and delays in patient care. She stressed the impact on vulnerable patient populations who rely on timely and accurate diagnostic tests for their medical needs.

In conclusion, Rodgers called for a reconsideration of the proposed rule, urging a focus on legislative alternatives to address the concerns raised. She expressed hope for bipartisan collaboration on finding a more suitable approach to regulating diagnostic tests to ensure continued innovation and access to essential healthcare services.