Special Advocacy Update

• CAP Letter Urges Trump Administration to Rescind FDA's LDT Regulation
• Lawmakers Must Stop the FDA Rule: CAP

The CAP has asked leaders of the Trump Transition Team to recommend the incoming administration rescind the Food and Drug Administration's (FDA) proposed regulation of laboratory-developed tests (LDTs), citing significant concerns about the rule’s potential to limit patient access to critical diagnostic services.

In a letter addressed to Transition Team Co-Chairs Linda McMahon and Howard Lutnick, CAP President Donald Karcher, MD, FCAP, outlined the organization's key concerns. Several other members of the Transition Team have also received the letter. “Pathologists and laboratories fear these regulatory restrictions from the FDA will make it difficult for laboratories to continue to develop and provide LDTs and, thus, impair and delay the diagnosis of disease and treatment of patients,” wrote Dr. Karcher.

He shared CAP’s support for a balanced approach to LDT oversight provided by the proposed VALID Act of 2023, which would create a three-tiered, risk-based regulatory system authorizing the FDA to regulate high-risk LDTs, while leveraging existing structures to improve and promote patient safety.

The CAP, representing over 18,000 board-certified pathologists, continues to work proactively with policymakers to develop a regulatory approach that balances patient safety with medical innovation.

Read the full letter here

With the end of the year quickly approaching, the CAP called on leaders in the House and Senate to pass a bill preventing the implementation of the FDA LDT oversight regulation. CAP President Donald Karcher, MD, FCAP sent a letter on November 20 to congressional leadership urging them to prevent the implementation of the harmful LDT rule.

For more than a month, hundreds of pathologists have asked their legislators to, at a minimum, delay implementation of the final rule and give Congress time to work with stakeholders to pass legislation that includes an appropriate oversight framework with a limited role for the FDA.

Read the full letter here