A band of medical device, public health, and patient and consumer advocacy organizations are pressuring Congress to pass a key diagnostics reform bill in a year-end package as the deadline for funding the government looms and talks of a potential longer term continuing resolution ramp up.
The bill at issue, the Verifying Accurate Leading-edge IVCT Development (VALID) Act, would create a risk-based regulatory framework for laboratory-developed tests (LDTs) and create a user fee program for in vitro clinical tests. As of Dec. 7, the text of the bill was being revised to potentially exempt some academic medical centers from the regulatory requirements, but the chances of VALID passing before the end of the year are still unclear, a source close to the negotiations told Inside Health Policy.
Members of the Senate health committee included VALID in their user fee package that cleared the committee in June, but the measures — and many other FDA reforms — were ultimately left out of the user fee bill that Congress passed at the end of September.
Supporters of VALID say the bill is critical for ensuring that patients have access to reliable diagnostic tests that ultimately determine their treatment.
In a letter to Senate health and House Energy & Commerce Committee leadership sent Tuesday (Dec. 12), the Pew Charitable Trusts, Advanced Medical Technology Association, Friends of Cancer Research and six other organizations wrote in support of VALID, saying it will resolve longstanding regulatory issues with diagnostics that ultimately harm patient outcomes.
“Absent these reforms, the current, outdated oversight of the development and quality of these tests will lead to inaccurate and unreliable tests and undermine clinical decision making and patient health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,” the groups wrote.
Just days before on Thursday (Dec. 9), Pew sent a separate letter sent to Senate health committee leadership saying it supports the revisions that were included in a discussion draft being discussed on Capitol Hill, including language exempting academic medical centers from premarket review. The group believes the exemptions are sufficiently narrow to ensure the quality of LDTs developed in academic medical centers.
The most recent version of VALID that was included in the Senate health committee user fee package did include exemptions for in vitro tests that met certain criteria, including if the test was offered for clinical use before the enactment of VALID. The bill did not previously include exemptions for academic medical centers.
“The edits to the discussion draft ensure that tests are exempt only when they are integrated into direct medical care for patients and used for patients receiving care or treatment at the same location as the lab,” the group wrote. “These narrow exemptions ensure that non-AMC labs cannot take advantage of exemptions, and that the stated needs of AMCs are met.”
Pew also voiced concerns that FDA wouldn’t have enough resources to fully implement VALID’s provisions. The group points to a requirement in the discussion draft that would limit FDA’s ability to spend user fees unless final regulations are published within three years of VALID’s enactment. Pew argues the timeline might be too rushed.
“FDA is already providing numerous reports to Congress about its implementation which, along with the public nature of the guidance process, provides a significant amount of transparency into FDA’s implementation process,” Pew wrote. “We urge the Committee to remove these restrictions.”
Hospital groups have been outspoken against VALID, holding the stance that the framework could lead to delays in developing LDTs and hinder patient access to innovative tests.
“Given the value of these tests to caregivers and patients, any framework for regulatory oversight of LDTs must ensure that the technological and clinical innovation that is essential to their development remains unrestricted; that quality and reliability are maintained at the highest levels possible; and that they continue to be widely accessible to patients,” the American Hospital Association wrote in a June letter to Senate health committee leadership.
The Children’s Hospital Association voiced similar concerns in June, saying that commercial diagnostic development for children often lags behind that of adults, making LDTs particularly important for children.
“LDTs fill a critical gap in the practice of pediatric medicine as they allow for accurate, timely and high-quality testing for many pediatric conditions for which no commercial test exists or where an existing test does not meet current clinical needs,” CHA wrote in a June letter to the Senate health committee.
FDA Commissioner Robert Califf has floated the idea of reforming the regulatory framework for diagnostics through rulemaking, should Congress fail to pass VALID this year. But a source told IHP last month it would be challenging to implement such major changes through rulemaking, and the source asserted that Califf’s comments were an attempt to pressure Congress to pass the bill this year. — Lia DeGroot (email@example.com)