FDA leaders talk adcomms, shortages

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May 17, 2024 View in browser   By Lauren Gardner and David Lim With help from Ben Leonard Top FDA officials suggest that giving the agency more authority could help it prevent drug shortages. | Joe Raedle/Getty Images FDLI ROUNDUP — Senior FDA officials gave a series of mini-updates on policy and agency issues ahead of the anticipated election-season slowdown at the Food and Drug Law Institute’s annual conference in Washington this week. Among the highlights: Advisory committees are back: In person, that is. The FDA plans to return to in-person advisory committee meetings beginning next month, with most officials expected to attend in person by September. “We really think it’s time to go back in person because we think that it’s a format that really leads to more robust and potentially higher quality decisions,” Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said Wednesday. Cavazzoni said the agency will continue to offer a hybrid option for people who can’t attend meetings in White Oak, Maryland. Drug shortages: Top FDA officials made the case that new powers could help the agency better respond to persistent drug shortages. Kimberlee Trzeciak, FDA deputy commissioner for policy, legislation and international affairs, argued that Congress should require drug manufacturers to notify the FDA of an increase in demand for drugs and to identify suppliers of active pharmaceutical ingredients. Dr. Jacqueline Corrigan-Curay, principal deputy director of the FDA’s drug center, said the agency does not want the power to compel drugmakers to make certain drugs. “A lot of what we do is really at the tail end; we’re coming in when you’re telling us when there is a disruption or there is a shortage,” Corrigan-Curay said. “It's almost like we’re in the emergency room.” Tobacco: Brian King, director of the FDA’s Center for Tobacco Products, hinted his office is working on civil monetary penalty guidance for when the agency seeks to fine companies for noncompliance. He said he hopes to release it this summer, though the guidance has to go through HHS and the White House Office of Management and Budget. Work on a nicotine product standard also continues, and the FDA aims to submit a proposed rule through “various clearance channels” in the coming months, he added. IT’S FRIDAY. WELCOME BACK TO PRESCRIPTION PULSE. David’s Califf bingo card was quite popular this week among senior FDA officials and other attendees of the FDLI conference. Send 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.     In Congress The House E&C Health Subcommittee, chaired by Rep. Brett Guthrie, advanced several bipartisan health policy bills Wednesday. | Anna Moneymaker/Getty Images E&C WATCH — The House Energy and Commerce Health Subcommittee advanced bipartisan bills Thursday related to drug development and the stem cell industry, Ben reports. The bills include: — The Give Kids a Chance Act, which would give the FDA authority to mandate pediatric cancer trials on combination therapies. The bill was amended to reauthorize the pediatric rare disease priority review voucher program. The bill advanced in a 16-11 vote. — The Shandra Eisenga Human Cell and Tissue Product Safety Act, which would require HHS to launch an education campaign on potential risks and benefits of cell and tissue transplants. It advanced in a 27-0 vote. Industry Intel A COMPOUND WAR OF WORDS — The trade association for compounding pharmacies blasted Eli Lilly on Thursday over the company’s statement this week regarding its settlement with a medical spa that was selling knock-off versions of Lilly’s weight-loss drugs. “We strongly support state and federal regulators taking action to deter and punish compounding pharmacies, counterfeiters, and others who put patients at risk by selling unsafe products claiming to be tirzepatide,” Lilly said Tuesday when describing its deal with Totality Medispa requiring the company not to suggest its products are FDA-approved. In a statement, Lilly said it’s the “only lawful supplier” of tirzepatide, the active ingredient in branded drugs Mounjaro and Zepbound, and that the drugmaker doesn’t sell the ingredient to compounders. But Scott Brunner, CEO of the Alliance for Pharmacy Compounding, said legitimate compounding pharmacies source tirzepatide from the same manufacturers Lilly uses. “Best to remember that it’s Lilly that is unable to supply its life-enhancing drug to patients right now,” he said in a statement. “So who exactly is putting those patients at risk?” BIRD FLU COOKING BEEF — Federal officials said Thursday that experiments show cooking beef to medium kills the avian influenza virus. But no virus has been found in retail ground beef samples tested to date. Notably, beef infected with an avian influenza virus surrogate cooked to rare reduced virus levels, POLITICO’s Marcia Brown and David report. The testing results should not impact consumers’ cooking habits for now because they were experimental samples injected with the virus in a lab, explained Eric Deeble, deputy assistant secretary for the USDA’s Office of Congressional Relations. “We’re doing this in the interest of determining the effectiveness of cooking on killing the virus, but we have not found in any of the samples taken at slaughter or from retail … to have any virus,” said Deeble. Eye on the FDA GOTTLIEB FLOODS THE ZONE — The loquacious former FDA Commissioner Scott Gottlieb returned to form at FDLI on Thursday, where he argued that the agency should take a more robust role in collecting and sharing data about how approved medical products perform in clinical practice. “In areas of true paradigm shifts — where proper adoption of an innovation requires a dynamic process between the FDA and providers, and where treatment guidelines must iterate quickly as we learn new things about incorporating novel paradigms into medical practice — FDA needs the tools to be a more active participant in that information space,” said Gottlieb, who works at venture capital firm New Enterprise Associates and the think tank American Enterprise Institute. The former Trump official argued that inventions, such as artificial intelligence, require the agency to consider new regulatory approaches to ensure the innovations can be adopted into clinical practice.   LISTEN TO POLITICO'S ENERGY PODCAST: Check out our daily five-minute brief on the latest energy and environmental politics and policy news. Don't miss out on the must-know stories, candid insights, and analysis from POLITICO's energy team. Listen today.     Pharma Moves Matthew Shields will become executive vice president of Teva Pharmaceutical Industries’ manufacturing and supply division next month. Alonzo Weems will retire from Eli Lilly as executive vice president of enterprise risk management and chief ethics and compliance officer at the end of the year. WHAT WE'RE READING A Biden administration program to ensure uninsured Americans have access to Covid-19 vaccines will end in August instead of at the end of the year, POLITICO’s Sophie Gardner reports. Document Drawer The FDA published several new draft product-specific guidances for drugs with certain active ingredients.   Follow us on Twitter David Lim @davidalim Lauren Gardner @Gardner_LM   Follow us

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