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In a surprise move Thursday (Dec. 6), bipartisan duos of House and Senate lawmakers released draft legislation that lays out a framework for FDA to regulate in vitro clinical tests, such as test kits and laboratory developed tests (LDTs). At first glance, the draft legislation appears to closely resemble a legislative proposal put forward by FDA in August that drew initial criticism from industry for its sweeping changes and unclear terminology. Lawmakers say that the Verifying Accurate, Leading-edge IVCT Development (VALID) Act would establish a risk-based approach towards the regulation of in vitro clinical tests, prioritizing FDA resources for tests that might expose patients to serious or irreversible harm. The bill would establish a precertification program for lower-risk tests, where FDA could establish standard validity requirements for non-novel, lower-risk tests, lawmakers explain. FDA is already pioneering a precertification program for software, though several Senate Democrats questioned FDA’s authority to implement such a program earlier this year. FDA’s legislative framework for diagnostic regulation included many other proposals, such as use of the term “test group” as a means of grouping similar tests for the purpose of determining clearance of new tests. FDA also suggested lawmakers bring labs and manufacturers under the same criteria for submitting applications for new tests; and give FDA power to withdraw the approval of a product if the test is revealed to be too dangerous. At first glance, it appears several of these ideas made it into the draft bipartisan legislation. Though several stakeholders criticized FDA’s proposal, the bill’s drafters write in a joint statement that they “have worked with the stakeholder community and FDA to define parameters for IVCT oversight,” implying that there could be significant changes in the bill designed to make the framework more palatable for industry. In their statement, Reps. Larry Bucshon (R-IN) and Diana DeGette (D-CO) and Sens. Michael Bennet (D-CO) and Orrin Hatch (R-UT) seemed to embrace wholeheartedly the proposal made by FDA Commissioner Scott Gottlieb, who had called for comprehensive legislation in the in vitro test space as early as March. “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,” said Hatch. “Americans deserve the assurance that the tests which are utilized in making vital, sometimes life-or-death, decisions, are both accurate and reliable.” “Unfortunately, the regulatory framework for diagnostic testing has become outdated and is still stuck in the 20th century,” said Bucshon. “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.” Gottlieb, FDA device center head Jeff Shuren, and FDA Chief of Staff Lauren Silvis defended their ideas in a statement released hours before the draft legislation came out. The agency heads called for increased standardization between FDA-reviewed tests and laboratory-developed tests; more transparency about the performance of laboratory tests; and a modernized, unified approach to the regulation of in vitro clinical tests. The FDA officials estimated that 40 to 50 percent of tests would fall under the proposed precertification program, while 10 percent would need individual premarket review. They wrote that they would focus individual premarket reviews on tests that are “novel, higher risk, marketed directly to consumers, used at home, or cross-labeled for use with a drug or other therapeutic products.”

“We’ve shared these ideas widely, with Congress, patient groups, providers, professional societies, and test developers,” they said earlier in the statement. “We appreciate the time and attention Congress has devoted to the critical subject of diagnostics regulation and look forward to continuing to work with them on these issues.” -- David Roza (droza@iwpnews.com)