VALID Act Could Limit Patient Access to LDTs

In a letter to members of Congress, AACC warned legislators that several provisions in the Verifying Accurate Leading-edge IVCT Development (VALID) Act could limit physician and patient access to state-of-the-art laboratory-developed tests (LDTs). The bill would expand the Food and Drug Administration’s (FDA) power to regulate LDTs, requiring premarket certification or approval depending on an FDA assessment of a test’s risk. Four lawmakers reintroduced the bill this year in June: Sens. Richard Burr, R-N.C., and Michael Bennet, D-Colo., and Reps. Larry Bucshon, R-Ind., and Diana DeGette, D-Colo. This marks the third time a version of the bill has come before Congress.

While support has emerged in the in vitro diagnostic (IVD) industry for improving and modernizing regulations for diagnostic test kits, AACC and other groups are concerned about how the bill would entangle clinical laboratories in duplicative rules specifically for LDTs.

In the letter, AACC said that the association “supports modernizing both the IVD and LDT regulatory processes, but through distinct approaches that optimize the regulation of each. While VALID identifies many proposals that may improve the effectiveness and efficiency of the IVD review process, the same proposals would cause irreparable damage if applied to LDTs.”

The letter also underscores how the bill’s expensive user fees, burdensome new technology certification process for laboratories, and cumbersome adverse-event reporting requirements would stifle innovation and reduce access to essential testing.

AACC maintains that refinements to LDT regulation ought to be discussed and acted upon within the Clinical Laboratory Improvement Advisory Committee (CLIAC), the federal advisory body that guides the Centers for Medicare and Medicaid Services on changes to CLIA standards.

IVD Industry Asks for Help With Semiconductor Chip Shortage

In September, the Department of Commerce issued a request for public comments on the risk in the semiconductor supply chain, prompting feedback from in vitro diagnostic (IVD) companies that the same semiconductor shortage affecting manufacturers of cars, appliances, and other electronic equipment now also threatens the supply chain for essential medical devices and diagnostics.

“The medical device industry’s primary needs are second or third generation chips, placing it in competition with automotive, industrial, and consumer industries for critical chips rather than high tech,” said AdvaMed in its comments to the Department of Commerce.

Broadly, two-thirds of medical device companies reported in an AdvaMed survey that they have semiconductors and firmware, or embedded software, in more than half of their products—and 50% reported that connected devices, which also require semiconductors, comprise half of their products. Some reported delays in receiving needed chips of up to a year.

Diagnostics company BD told the agency that over-ordering and competition are significant causes of the shortage for IVD firms. “Proper allocation with priority attention to industries supporting pandemic preparedness must be addressed with suppliers at all levels to prohibit companies from buying products and reselling them on the open market,” BD said. “This is exacerbating the shortage through panic buying and creating an environment ripe for counterfeit activity. For the healthcare industry, inflationary costs will have an adverse impact on patient access to medical products.”

Importantly, IVD and other companies in the medical device space face an even higher barrier than companies making consumer products, according to AdvaMed, as substitute or replacement chips must be validated before they’re used in patient care and might even require regulatory review from the Food and Drug Administration.

As the semiconductor supply chain deteriorates, the Semiconductor Industry Association is asking policymakers for a tax credit on semiconductor research and development in the U.S. “The industry continues to grapple with a widespread global semiconductor shortage brought on by unpredictable and increased demand resulting from the COVID-19 pandemic, as well as a decreasing share of global front-end fabrication capacity fueled by incentives and subsidies provided by foreign governments that far outstrip similar incentives in the U.S.,” the association said.