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).
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