AdvaMed Leads Letter Urging Lawmakers to Support Bipartisan Diagnostics Reform
WASHINGTON, D.C. – Today, AdvaMed, joined by American Cancer Society Cancer Action Network, The Pew Charitable Trust, Friends of Cancer Research, and other, sent a letter urging the leaders of the Senate Committee on Health, Education, Labor and Pensions (HELP) and the House Committee on Energy and Commerce to support the bipartisan Verifying Accurate, Leading-edge IVCT Development (VALID) Act for regulatory oversight of in vitro clinical tests (IVCTs) – including in vitro diagnostics (IVDs) and laboratory-developed tests (LDTs). The coalition of 9 organizations, which represents the millions of patients, called for the swift passage of the legislation before the close of the 117th Congress.
“[W]e are concerned about longstanding regulatory issues that will jeopardize the advancement of the next generation of diagnostics and, thus, patient outcomes,” the group wrote in the letter to Congressional leaders. “To address these concerns, which have been recognized by administrations of both political parties, we urge you to support the VALID Act discussion draft currently under review by the committee and include it on an end of year appropriations package.
“The VALID Act would be an important step forward for patients and their clinicians who expect the highest quality innovative tests available to diagnose and treat illnesses. Absent these reforms, the current, outdated oversight of the development and quality of these tests will lead to inaccurate and unreliable tests and undermine clinical decision making and patient health outcomes.”
Read the full letter, which was signed by AdvaMed, American Cancer Society Cancer Action Network, Association for Clinical Oncology, Association of Black Cardiologists, College of American Pathologists, Friends of Cancer Research, Heart Valve Voice US, LUNGevity Foundation, and The Pew Charitable Trust, here.
A key priority for AdvaMed members, the Association has led efforts over the course of the 117th Congress to ensure this legislation is enacted, including calling on Congressional leaders to include the reforms in the Food and Drug Administration Safety and Landmark Advancements (FDSLA) Act of 2022.
Earlier this year, AdvaMed President and CEO Scott Whitaker praised the impact the VALID Act would have for patients and the medtech industry, saying, “The bipartisan VALID Act is an important step toward the long-overdue modernization of the law for all diagnostic tests. It calls for smart reforms that will incentivize and improve the development of the advanced, reliable tests patients depend on, regardless of where those tests were developed.”