Francis S. Collins, MD, PhD, a renowned physician-geneticist and former director of the NIH, revealed he has prostate cancer. In a perspective piece published in the Washington Postopens in a new tab or window, Collins said he went public to “share lifesaving information, and I want all men to benefit from the medical research to…
Abstract: Congress passed legislation on March 22 that cut funding for the NIH and NCI through the remainder of fiscal year 2024. Members of the cancer community want funding levels for these agencies to be restored during the next budget go-round. Fiscal year 2025 begins on October 1. Advocates hope funding levels are restored in…
The Biden administration is facing a looming deadline in the next few months to finalize key health care rules. If agencies take too long to finish regulations on minimum staffing levels at nursing homes, discrimination and abortion data protections, a ban on menthol cigarettes and others still in the pipeline, they could all disappear next…
On March 21, 2024, the Health Subcommittee of the House Energy & Commerce Committee held a hearing titled “Evaluating Approaches to Diagnostic Test Regulation and the Impact of the FDA’s Proposed Rule.” In the wake of repeated congressional inaction on the Verifying Accurate Leading-edge IVCT Development Act or the “VALID Act” (S. 2209/H.R. 2369), which would establish a…
With the US Food and Drug Administration (FDA) likely in coming weeks to release its final rule on regulation of laboratory-developed tests (LDTs), Congress has indicated interest in once again taking up oversight of such tests and reforming diagnostics regulation. This month, US Sen. Bill Cassidy, R-La., issued a Request for Information (RFI) asking stakeholders for input…
Creating a regulatory framework for laboratory-developed tests shouldn’t be as complicated as the tests themselves. But months after Congress failed to advance legislation that would have established that framework — and with the FDA’s final rule on LDT regulation set to drop — lawmakers on the Hill continue to debate the issue, with many arguing…
The VALID Act and the regulation of diagnostic tests resurfaced at a House Energy and Commerce hearing today that coincided with the FDA finalizing a rule that would give it oversight for four years. The big picture: Trade groups mostly supported Congress taking action on oversight of the tests, with some explicitly endorsing the VALID…
Republicans and Democrats sharply disagree over how Congress should legislate the oversight of medical tests amid a push by the FDA to finalize regulations for some tests next month. GOP members of the House Energy and Commerce Health Subcommittee argued on Thursday that the agency overstepped its authority by proposing that many laboratory-developed tests be…
The VALID Act appeared to win hearts over the hammer of a forthcoming U.S. Food and Drug Administration (FDA) final rule expected to drop heavy regulations on clinical laboratory developed tests (LDTs), a hearing of the House Subcommittee on Health revealed Thursday. Medical technology trade organization AdvaMedDx and other clinical lab stakeholders appeared before members…
The Food and Drug Administration’s plan to expand oversight of laboratory-developed tests threatens to prevent or delay patient access to innovative diagnostics, industry groups warned in congressional testimony Thursday. The FDA’s final rule on LDT regulation, which could come as soon as April, has unleashed a fierce debate over how to protect the health and safety of patients…
