Industry leaders are calling on Congress to modernize legislation covering clinical laboratory diagnostics to bring it into the 21st Century.
A May 9 letter sent to Sen. Lamar Alexander (R-Tenn.), Sen. Patty Murray (D-Wash.), Rep. Greg Walden (R-Ore.) and Rep. Frank Pallone (D-N.J.) urges them to move quickly on comprehensive legislative reform to ensure patients have access to innovative and high quality clinical laboratory diagnostics.
Signed by organizations representing patient advocates, providers, laboratories and diagnostics manufacturers, the letter says there is an urgent need to reform regulations covering laboratory developed tests (LDTs) and in vitro diagnostics (IVDs). Currently, the FDA regulates IVDs but does not actively regulate LDTs.
“FDA Commissioner Scott Gottlieb has made repeated public comments that comprehensive legislative reform of clinical laboratory diagnostics is timely and appropriate,” the letter says.
New Pathway In The Works
Gottlieb told the World Economic Forum in Davos, Switzerland, earlier this year that the FDA would be looking for new authority to regulate diagnostics.
“I think it’s time that the agency needs to work with Congress and stakeholders to develop very specific targeted legislation that would give us a unique set of authorities to regulate diagnostics properly,” Gottlieb said.
“My view is that the old 510(k), PMA pathway…the traditional pathway for approving medical devices, doesn’t really fit well with modern diagnostics, and we need very well-fashioned authorities when it comes to diagnostics” (IDDM, Feb. 5).
Last year, Representatives Larry Buchson (R-Ind.) and Diana DeGette (D-Colo.) circulated a discussion draft called the Diagnostic Accuracy and Innovation Act (DAIA) that would create a new regulatory structure for in vitro clinical tests (IVCTs) that would comprise both IVDs and LDTs and would be regulated separately from devices, drugs, and biologics.
The discussion draft would establish FDA jurisdiction over IVCT development and manufacturing while maintaining Centers for Medicare and Medicaid Services’ (CMS) oversight of laboratory operations. It also would establish a regulatory structure for IVCTs that addresses risk classification, premarket requirements, modifications, quality, post-market monitoring, and innovation (IDDM, April 3, 2017).
Bucshon and DeGette invited comments on the draft and were to formally introduce legislation after reviewing the comments, a spokesman for Bucshon told FDAnews.
They said the proposal would bring “much needed certainty” to the diagnostic industry by applying the same regulatory principles to the same activity regardless of where a test is developed.
AdvaMed said in its comments on the DAIA draft that the association has long supported FDA oversight of all diagnostics, including LDTs. “Maintaining two very different oversight mechanisms for tests based only on who develops them is bad public policy,” the association said, because it leads to clinical use of tests without sufficient clinical data and stifles innovation of high quality diagnostics.
The association said it supported the proposed legislation in principle, although it was concerned about some of the timelines proposed.
In January, instead of finalizing draft LDT guidance, the FDA released a discussion paper outlining a possible approach that would focus on new and significantly modified high- and moderate-risk LDT (IDDM, Jan. 16, 2017).
“Stakeholders have never been more aligned on the need for diagnostics reform than we are now,” the letter says. “We believe the goal of a new statutory framework is within reach.”
Read the letter here: www.fdanews.com/05-15-18-Letter.pdf.