NO CONSENSUS ON LDT REGULATION — Lawmakers on the House Energy and Commerce Health Subcommittee suggested on Thursday that they are open to legislating rules of the road for laboratory-developed tests with the FDA moving forward with regulations. But there is no agreement on what approach to take if a health care package emerges later this year. Meanwhile, the FDA is working to finalize rules that would regulate the tests as medical devices. The Biden administration wants to publish the final rule in April, a move that would shield it from being clawed back if Republicans control the presidency and Congress next year. Several groups — including the American Clinical Laboratory Association, the Children's Hospital Association and the Center for Science in the Public Interest — are scheduled to meet with the Office of Management and Budget to discuss the rule in the coming weeks. VALID Act: The FDA moved forward with its rule in October because a legislative effort to overhaul how all medical tests are regulated fell apart in late 2022 after E&C Chair Cathy McMorris Rodgers (R-Wash.) blocked the bill. The industry perspective: Susan Van Meter, president of the ACLA, testified that the FDA rule, if finalized as proposed, would slow test innovation, create a review bottleneck at the FDA and raise legal questions. “An exemption for academic medical centers is not the answer to these problems,” Van Meter said, referring to an idea floated in 2022 after academic medical centers opposed the Verifying Accurate Leading-edge IVCT Development Act. HEALTH BILLS ADVANCED — The House Energy and Commerce Committee on Wednesday approved more than a dozen health care bills, many of which reauthorize programs scheduled to expire at the end of the fiscal year on Sept. 30. Bills to extend the National Alzheimer’s Project, reauthorize a public health network for Alzheimer’s patients, continue programs for traumatic brain injuries and boost funding for Down syndrome research were unanimously advanced. VACCINE SAFETY EXAMINED — The House Oversight Select Subcommittee on the Coronavirus Pandemic is investigating U.S. vaccine safety systems, with a focus on compensation programs that experts say weren’t designed to handle what has become an onslaught of claims from adults. The Thursday hearing was the second on the issue. The National Vaccine Injury Compensation Program and a separate program for medical products developed during health emergencies — like the Covid-19 vaccines when they were available under FDA emergency use authorization — have been slow to process claims. “The assurance of adequate and timely compensation of vaccine-related injuries in exchange for legal liability protection for vaccine manufacturers is a cornerstone of routine and pandemic immunization programs,” said Renée Gentry, director of the George Washington University Vaccine Injury Litigation Clinic. “The success of these programs relies on public confidence in vaccines.” Rep. Lloyd Doggett (D-Texas) for years has pushed legislation to overhaul the VICP by adding special masters to the court that hears vaccine injury claims and by transferring Covid-related claims to that program. But Republicans have raised concerns about the measures’ cost.
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