U.S. Rep. Larry Bucshon (R-IN) and U.S. Sen. Orrin Hatch (R-UT) last week unveiled bicameral, bipartisan draft legislation to ensure greater oversight, accuracy and safety around in vitro clinical tests (IVCTs), including diagnostic and genetic tests.
“Advanced diagnostics are transforming the way we provide care for patients in the 21st century, giving rise to precision medicine and enabling physicians to provide more individualized treatments for patients,” said Rep. Bucshon. “Unfortunately, the regulatory framework for diagnostic testing has become outdated and is still stuck in the 20th century.”
The draft of the Verifying Accurate, Leading-edge IVCT Development (VALID) Act would establish a risk-based approach to IVCT regulation that prioritizes federal U.S. Food and Drug Administration (FDA) resources for any high-risk tests that could expose patients to serious or irreversible harm, according to a summary of the discussion draft provided by Rep. Bucshon’s office.
“Americans deserve the assurance that the tests which are utilized in making vital, sometimes life-or-death, decisions, are both accurate and reliable,” Sen. Hatch said. “This bill establishes a sensible, risk-based approach towards regulation of IVCTs that protects innovation in an ever-changing sector of healthcare.”
Currently, the U.S. Centers for Medicare and Medicaid Services (CMS) is required by federal law to guarantee quality operations exist for laboratory developed tests (LDTs). However, CMS isn’t required to ensure safety and effectiveness for any IVCTs, according to a statement from Rep. Bucshon’s office.
In March, FDA Commissioner Scott Gottlieb urged Congress pass “comprehensive legislation” regarding IVCT oversight after several IVCTs voluntarily pursued FDA approval under the existing device regulation framework, according to his statement.
The discussion draft released on Dec. 6 would establish the oversight framework at the FDA for IVCTs, such as test kits and LDTs, according to Rep. Bucshon, who was joined in introducing it by U.S. Rep. Diana DeGette (D-CO), his colleague on the U.S. House Energy and Commerce Committee, and by Sens. Hatch and Michael Bennet (D-CO). The senators serve on the U.S. Senate Health, Education, Labor, and Pensions Committee. The lawmakers have defined parameters for IVCT oversight in the bill in cooperation with the FDA and a variety of stakeholders.
“Our goal with this draft legislation is to ensure patients can get the most appropriate treatment for their disease by creating a new regulatory framework that is risk based, creates a level-playing field, allows for leading edge development to thrive, and assures doctors and patients that their test results are valid and clinically meaningful,” said Rep. Bucshon, a licensed medical doctor.
Additionally, the measure would establish a precertification program for lower-risk tests that don’t require a premarket review, according to the lawmaker’s summary, which noted that precertification would permit the FDA to create standard validity requirements, while simultaneously reducing the burden on labs and developers and allowing for ongoing innovation.
High-risk tests would require premarket reviews to verify analytical and clinical validity, although the FDA could require such a review for any test after allowing the test developer the chance to address any issues.
“Safety and accuracy are rightly our top priorities when establishing a new regulatory framework for the approval and regulation of LDTs and IVCTs,” Rep. DeGette said.
Sen. Bennet noted that as diagnostic and genetic tests have become increasingly used in routine medical care, it’s important for safety measures to be put in place for them. Without them, he said, “these tests threaten patient safety and the potential of innovative diagnostics to transform health care.”
The lawmakers plan to continue fine-tuning the development of a regulatory framework that produces better oversight and keeps pace with developing technologies.
“While I am disappointed this bill will not pass this year, I am hopeful that my colleagues will prioritize this legislation in the 116th Congress,” added Sen. Hatch.