Lawmakers behind a bill to revamp diagnostics regulation are eyeing FDA user fee legislation as a vehicle for pushing their proposal across the finish line.
“The time for Congress to clarify the rules of the road for diagnostic testing is now,” Rep. Larry Bucshon (R-Ind.) said Tuesday during a Friends of Cancer Research event. He and Rep. Diana DeGette (D-Colo.) are working to advance their measure, nearly a decade in the making, “on its own or attached to must-pass bills like MDUFA,” the next iteration of the Medical Device User Fee Amendments that’s up for renewal this year.
Their bill, known as the VALID Act (H.R. 4128), would establish a new framework for the Food and Drug Administration to regulate diagnostic tests. It would create a category of medical products called in vitro diagnostic tests, instead of keeping them as a subcategory within device regulations. That would allow the FDA to oversee tests regardless of whether they came from clinical laboratories or from commercial companies.
A companion bill (S. 2209) has also been introduced in the Senate. Neither bill has seen action, but legislation dictating the rates that device makers pay the agency often includes policy riders that go beyond user fees and presents a fresh opportunity for the VALID Act. Congress must pass a law adopting the next iteration of device user fees for fiscal years 2023 through 2027 before the current one expires Sept. 30.
“This year is a pivotal year for VALID, and I look forward to continuing to work with you all to help get it across the finish line so that we can provide certainty to patients and modernize regulatory oversight of in vitro diagnostic tests to better promote innovation and advancements,” Bucshon said.
Congress is still waiting on the FDA to send along its reauthorization commitment letter for the user fee legislation, although the deadline lapsed more than a month ago.
Lab-Developed Tests
The VALID Act, which the bipartisan duo reintroduced last summer, aims to resolve a longstanding debate about whether and how much authority the FDA has to oversee tests regardless of who made them.
The agency already regulates tests from the commercial sector but historically hasn’t regulated tests developed in a single laboratory, which are known as laboratory-developed tests. They would all be regulated as in vitro diagnostics under the DeGette-Bucshon bill, with some exceptions.
The FDA has sought to exert more control over lab-developed diagnostics as they’ve evolved from simple, limited tests to next-generation sequencing that can screen millions of DNA strands at a time. But laboratories already must meet quality and safety regulations from the Centers for Medicare & Medicaid Services and have expressed concern in the past about being doubly regulated.
The VALID Act has undergone several drafts over the years to address these concerns while allowing the FDA to ensure the tests are both accurate and useful.
“If there’s one thing that we learned during Covid-19, it is the importance of having accurate and reliable diagnostic testing,” DeGette said at the Friends event. “The accuracy and the reliability of these tests can literally be the difference between life and death for some patients.”
The bill would allow hospitals and labs to start using diagnostics more quickly in a public health emergency if they’ve validated the tests and provided that data to the FDA. The framework “would provide a new way to approve diagnostic tests that seek to identify an infectious disease like Covid-19 and countless other conditions, while at the same time ensuring patient safety,” DeGette said.
Rare Diseases
The measure also would establish a program to speed FDA review of diagnostic tests that address an unmet need for patients, such as those with rare diseases.
Many rare diseases are genetic, so potential treatments could benefit from having a companion diagnostic developed alongside it to ensure that that medicine is right for that patient. But one of the biggest challenges is procuring enough samples to validate the tests for accuracy, Elizabeth Mansfield, vice president of regulatory affairs for Foundation Medicine and the former head of the personalized medicine program in FDA’s device center, said during the Friends meeting.
“There is a lot of competition for the same samples in the world. And when they start out rare, adding in competition makes it even more difficult.”
Friends released a white paper Tuesday addressing some of these challenges. Its recommendations seek to improve the development of biomarkers, measurements that serve as an indicator of a normal biological or pathogenic process, or response to a medical intervention. The paper also aims to maximize FDA’s regulatory flexibility to ease the development of these tests for smaller populations.
