Waiting on OIRA for final LDT rule

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Apr 23, 2024 View in browser   By David Lim Driving the Day The FDA is getting some pushback over its intent to issue a final rule to treat laboratory-developed tests as medical devices. | David Silverman/Getty Images WAITING ON THE WORLD TO CHANGE — The election year is beginning to settle, so the number of FDA actions is starting to noticeably slow. But one major outstanding regulation close watchers of the agency expect to be finalized soon is the agency’s plan to treat laboratory-developed tests as medical devices. As late as last Friday, the White House Office of Information and Regulatory Affairs was meeting with outside groups to discuss the final rule under its review. Groups, including the College of American Pathologists, told the Biden administration that they have concerns about the FDA’s October 2023 proposed rule. “We believe the rule, as written, would significantly burden clinical laboratories, making it very difficult and unacceptably costly for these laboratories to continue to develop much-needed and innovative LDTs, resulting in patients being deprived of these life-saving tests,” Dr. Donald Karcher, president of the College of American Pathologists, wrote Friday to OMB Director Shalanda Young. The FDA plan did not draw fans when it proposed the rule — and even agency officials have said they would prefer that Congress take action to create a new framework to regulate diagnostics and lab tests. But legislation known as the Verifying Accurate Leading-edge IVCT Development Act failed to ride on omnibus legislation in 2022 — a development that FDA officials say forced the agency to pursue rulemaking in the space. HHS Secretary Xavier Becerra signaled to Rep. Gus Bilirakis (R-Fla.) — who previously opposed the VALID Act — last week the forthcoming rule will not exempt academic medical centers from new testing regulations. “There should not be exceptions unless they are absolutely necessary,” Becerra said. “Academic institutions are saying that they should be outside the scope of that. We’re saying there is no reason why in the process of making all tests work well that we should allow academic institutions to be treated better or differently.” Industry’s wish: Susan Van Meter, executive director of the American Clinical Laboratory Association, told Prescription Pulse on Monday that her trade group — which represents large labs such as Quest Diagnostics and Labcorp — still wants the Biden administration not to issue the final rule. “We continue to encourage the administration to halt the rulemaking and to reengage with us on the Hill to do what we think is the right approach to ensuring that there’s continued access to testing,” Van Meter said. IT’S TUESDAY. WELCOME BACK TO PRESCRIPTION PULSE. Thinking summer was here already? Big mistake. Send Survivor predictions, news and tips to David Lim (dlim@politico.com or @davidalim) and Lauren Gardner (lgardner@politico.com or @Gardner_LM).   THE GOLD STANDARD OF HEALTHCARE POLICY REPORTING & INTELLIGENCE: POLITICO has more than 500 journalists delivering unrivaled reporting and illuminating the policy and regulatory landscape for those who need to know what’s next. Throughout the election and the legislative and regulatory pushes that will follow, POLITICO Pro is indispensable to those who need to make informed decisions fast. The Pro platform dives deeper into critical and quickly evolving sectors and industries, like healthcare, equipping policymakers and those who shape legislation and regulation with essential news and intelligence from the world’s best politics and policy journalists. Our newsroom is deeper, more experienced and better sourced than any other. Our healthcare reporting team—including Alice Miranda Ollstein, Megan Messerly and Robert King—is embedded with the market-moving legislative committees and agencies in Washington and across states, delivering unparalleled coverage of health policy and the healthcare industry. We bring subscribers inside the conversations that determine policy outcomes and the future of industries, providing insight that cannot be found anywhere else. Get the premier news and policy intelligence service, SUBSCRIBE TO POLITICO PRO TODAY.     AROUND THE AGENCIES Despite the Biden administration's efforts to protect abortion records with a new rule, Sen. Ron Wyden says the regulations don't go far enough. | Francis Chung/POLITICO HIPAA TO PROTECT ABORTION RECORDS? The Biden administration finalized its plan Monday to use HIPAA protections to shield abortion records — but a top Senate Democrat says current regulations do not go far enough. “I fear this final rule by HHS misses the mark, failing to protect reproductive health records from warrantless law enforcement demands, as well as medical records associated with other sensitive categories of health information,” Sen. Ron Wyden (D-Ore.), chair of the Senate Finance Committee, said in a statement after the final rule’s release. The lawmaker said he “will be exploring additional avenues to meaningfully protect Americans’ health privacy.” H5N1 GENETIC SEQUENCES — The USDA’s Animal and Plant Health Inspection Service published 239 genetic sequences over the weekend from samples “associated with the ongoing highly pathogenic avian influenza outbreak.” Eye on the FDA CALIFF RECOUNTS EURO TRIP — FDA Commissioner Robert Califf wants the U.S. to pay attention to the United Kingdom’s projects like the U.K. Biobank, which generates clinical evidence to support decision making. That effort, he says, has “arguably … been the most important human biobanking project of our time.” The FDA leader said one observation from his trip to Europe earlier this year was that the U.K.’s National Health Service has integrated clinical trial participation into the health care system. Better clinical trial design has been a pillar of Califf’s focus atop the FDA — in testimony and speeches, he routinely touts the need for high-quality evidence generation in trials. “As we move into an era of large trials to reliably detect modest differences in outcomes from major diseases, collaboration among the FDA, NIH, and CDC will be critical to develop a post-market ecosystem to support pragmatic clinical trials, registries and clinical epidemiology,” Califf wrote in a blog published Monday.   POLITICO IS BACK AT THE 2024 MILKEN GLOBAL CONFERENCE: POLITICO will again be your eyes and ears at the 27th Annual Milken Institute Global Conference in Los Angeles from May 5-8 with exclusive, daily, reporting in our Global Playbook newsletter. Suzanne Lynch will be on the ground covering the biggest moments, behind-the-scenes buzz and on-stage insights from global leaders in health, finance, tech, philanthropy and beyond. Get a front-row seat to where the most interesting minds and top global leaders confront the world’s most pressing and complex challenges — subscribe today.     In Congress PHARMACISTS FLY IN — A number of trade groups, including the Medical Device Manufacturers Association and the National Community Pharmacists Association, held fly-ins last week on Capitol Hill. On Monday, the NCPA said community pharmacists held more than 250 meetings with congressional offices to advocate for legislation that would impact the pharmacy benefit managers that negotiate prescription drug prices for health insurers. The Drug Price Transparency in Medicaid Act and the Neighborhood Options for Patients Buying Medicines Act were among the legislation they lobbied for. WHAT WE’RE READING HHS and the Sequoia Project took another step Monday to implement a nationwide data-sharing network for patient health data, POLITICO’s Ben Leonard reports. The Biden administration finalized its plan Monday to mandate stronger nursing home staffing levels, POLITICO’s Robert King and Daniel Payne report. Document Drawer Peter Marks, director of the Center for Biologics Evaluation and Research, is slated to speak to the Alliance for a Stronger FDA on the FDA’s budget request today at 2 p.m. The FDA will convene its Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee on May 23 to discuss Guardant Health’s application for a diagnostic test intended to detect colorectal cancer signs in cell-free DNA from blood.   Follow us on Twitter David Lim @davidalim Lauren Gardner @Gardner_LM   Follow us

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