| | | | |  | | By David Lim and Lauren Gardner | Presented by Idorsia Pharmaceuticals | With Daniel Payne
| | |  The announcement from Biogen that it will no longer produce the Aduhelm garnered mixed reactions. | Biogen via AP | BIOGEN PULLING ALZHEIMER’S DRUG — Biogen’s decision this week to discontinue production of Aduhelm and relinquish its license for the drug drew a mixed bag of criticism and praise — much like its accelerated approval did in 2021. The highly scrutinized treatment faced growing pressure in the marketplace as competitor Leqembi won traditional FDA approval with slightly better clinical trial results and an Eli Lilly drug candidate could debut this year. The FDA’s confirmatory study requirement for Aduhelm — and CMS’ decision to limit coverage of amyloid plaque-targeting treatments — contributed to limited uptake of the $28,000 treatment. About 1,000 U.S. patients take it, a Biogen spokesperson told Prescription Pulse. “We need to look at how do we get clinical trials affordable so that people can move forward with it but make sure they’re also safe and effective,” House Energy and Commerce Health Subcommittee Chair Brett Guthrie (R-Ky.) told Lauren during a POLITICO event on Alzheimer’s drug innovations. Laying the groundwork: Dr. Nathaniel Chin, medical director for the Wisconsin Alzheimer's Disease Research Center, said at the event he thinks Aduhelm “played a large role in where we are today” — regardless of one’s opinion on the FDA’s approval. “It put a new emphasis on early detection, and really it emphasizes the advancements in technology that we have and the ability to identify changes in the brain in living people,” he said. Or taking steps backward: Dr. Aaron Kesselheim, a Harvard professor who resigned from the FDA’s independent panel that advised the agency against Aduhelm’s approval, rejected the notion that Leqembi’s approval “was facilitated because of this debacle,” given its positive trial results. Biogen should have redesigned its trials for the drug in 2019 when an independent panel found the drugmaker was unlikely to meet its objective, Kesselheim said, the results of which would probably be known by now and provide more clarity on its safety and efficacy. “This set the field back in many respects,” he said of Aduhelm’s approval. “I don’t see how this helps either the Alzheimer’s disease field or regulatory science.” IT’S FRIDAY. WELCOME BACK TO PRESCRIPTION PULSE. We’ve made it to February, everyone. Send news and tips to Lauren Gardner (lgardner@politico.com or @Gardner_LM) or David Lim (dlim@politico.com or @davidalim).
| | | | A message from Idorsia Pharmaceuticals: Chronic insomnia can wreak havoc on one’s mental and physical health. Many insomnia patients are living in limbo, as previous medications did not work, but their ability to access newer treatments is restricted. Learn more. | | | | | | | 
CMS sent its price offers to drugmakers of the 10 drugs chosen for Medicare negotiation but hasn't shared the bids with the public. | Joe Raedle/Getty Images | SHOWCASE SHOWDOWN — The Biden administration sent out its initial price offers Thursday for the 10 products chosen for the first round of Medicare negotiations. Drugmakers and CMS remained tightlipped on what those bids are, citing confidential business information. Still, it’s doubtful any of the companies think the price is, ahem, right. “You can’t call it a negotiation when the federal government has the ability to force you to accept their price or face an excise tax that can total 1900% of all your sales,” Neil Bradley, the U.S. Chamber of Commerce’s executive vice president and chief policy officer, said in a statement. The Chamber is behind one of nine lawsuits challenging the program’s constitutionality.
| | | | CONGRESS OVERDRIVE: Since day one, POLITICO has been laser-focused on Capitol Hill, serving up the juiciest Congress coverage. Now, we’re upping our game to ensure you’re up to speed and in the know on every tasty morsel and newsy nugget from inside the Capitol Dome, around the clock. Wake up, read Playbook AM, get up to speed at midday with our Playbook PM halftime report, and fuel your nightly conversations with Inside Congress in the evening. Plus, never miss a beat with buzzy, real-time updates throughout the day via our Inside Congress Live feature. Learn more and subscribe here. | | | | | | | | | THE QUIET PART OUT LOUD — FDA Commissioner Robert Califf acknowledged there is sometimes political pressure to get policies across the finish line during the final year of a presidential term. The agency is pushing to finalize regulations on flavored cigars and menthol cigarettes — but the final rule is not quite done yet, Biden’s FDA chief told the Alliance for a Stronger FDA. “Then we intend to put out a proposal on the nicotine standard, which is going to cause a lot of national discussion,” Califf said. Another push that is drawing “a lot of opinions,” Califf said, is the FDA’s proposal to bring laboratory-developed tests under stricter regulations — but the plan “is moving along in important ways.” FDA IN A SECOND TRUMP ADMINISTRATION — If former President Donald Trump wins a second term, former FDA Commissioner Scott Gottlieb doesn’t expect the agency to operate as independently as when he led it. “In a second term, there would probably be more recognition of the importance of controlling the administrative agencies,” Gottlieb said at a Friends of Cancer Research event on Thursday. “There may be less autonomy than there was in the first term.” Gottlieb said there was “a little less adult supervision” of federal agencies during Trump’s term — meaning that as long as the White House was apprised of issues it cared about, the agency was allowed to “manage the rest of the portfolio.” He suggested that if the agency had been able to carve out premium cigars from tobacco regulations being weighed during his tenure, restrictions on menthol cigarettes and nicotine levels could have been accelerated. “If it's a choice between, you know, getting a whole regulatory regime implemented that’s going to provide a lot of public health benefit and carving something out and worrying about it a little later, I would take the 90 percent,” Gottlieb said.
| | | | A message from Idorsia Pharmaceuticals:   | | | | | TAX BILL CONTAINS R&D GOODIES — A bipartisan tax bill that overwhelmingly passed the House on Wednesday contains a provision that delays a requirement that businesses deduct research and development spending over five years instead of immediately — a policy the medical device industry quickly praised. “The way R&D expensing is handled under current tax law is especially challenging for the small and emerging companies that make up more than 80 percent of the medtech industry,” AdvaMed CEO Scott Whitaker said. FIRST IN RxP: A BIPARTISAN 340B PLAN — A Senate 340B bipartisan working group discussion draft led by the chamber’s number two Republican floats a variety of policies aimed at boosting transparency in the 340B drug discount program — including a user fee scheme that aims to create a clearinghouse to “prevent duplicate discounts and ensure proper accounting.” It also attempts to define the role of contract pharmacies in the program. Why it matters: Sen. John Thune (R-S.D.) spokesperson Annie Topp said the goal is to pass legislation this Congress — and the discussion draft lays out the pathway to get there.
| | FDA TO LOOSEN DIAGNOSTICS REGS — A new FDA plan to regulate many diagnostic tests used to detect infectious diseases or determine whether a drug is suited to a specific person as moderate-risk medical devices instead of high-risk will inject more competition into the diagnostics market, Gottlieb said Thursday. The push to loosen regulations on some diagnostic tests will also make the FDA’s plan to regulate more laboratory-developed tests as devices more palatable, he added. “It's going to substantially lower the costs of the regulation,” Gottlieb said. “It makes that much more likely to get implemented.”
| | AN ‘OOPS’ LOOPHOLE? University of Maryland researchers say in a new JAMA paper that the FDA inadvertently created a safe harbor when it released guidance saying some artificial intelligence products, such as those that summarize doctors’ notes, wouldn't be considered medical devices subject to FDA rules. The guidance, released just two months before ChatGPT revolutionized AI, suggested the agency didn’t consider note-taking AI within its purview because the technology doesn’t make specific predictions or disease estimates. The authors write that, even if the FDA were to seek to write rules for such AI products, it might fail without receiving explicit new authority from Congress.
| | | | DON’T MISS POLITICO’S GOVERNORS SUMMIT: Join POLITICO on Feb. 22 to dive into how Governors are wielding immense power. While Washington remains gridlocked, governors are at the center of landmark decisions in AI and tech, economic development, infrastructure, housing, reproductive health and energy. How are they setting the stage for the future of American politics, policies and priorities? How are they confronting major challenges? Explore these questions and more at the 2024 Governors Summit. REGISTER HERE. | | | | | | | | François-Xavier Roger will become Sanofi’s chief financial officer on April 1. He’ll join the drugmaker from Nestle.
| | Principal Deputy Commissioner Janet Woodcock’s departure from the FDA after 37 years leaves the agency without one of its biggest champions for modernizing how it approaches drug regulation, your morning hosts write. A federal judge this week appeared skeptical of AstraZeneca’s arguments against Medicare’s drug price negotiation program, STAT reports.
| | Seven former commissioners and acting commissioners of the FDA filed an amicus brief to the Supreme Court on Thursday, arguing that upholding a lower court’s medication abortion access ruling to stand would “upend FDA’s drug approval system and harm patients.”
| | | | A message from Idorsia Pharmaceuticals: Chronic insomnia can wreak havoc on one’s mental and physical health. Many insomnia patients are living in limbo, as previous medications did not work, but their ability to access newer treatments is restricted. These newer medications, known as dual orexin receptor antagonists, or DORAs, block the binding of the wake-promoting neuropeptides orexins and turn down overactive wakefulness, as opposed to treatments that generally sedate the brain.
In 2023, Idorsia Pharmaceuticals, which markets one of the DORA drugs, filed a Citizen Petition urging the Drug Enforcement Administration (DEA) to de-schedule the DORA class of chronic insomnia medications based on a review of available data and real-world evidence. With addiction becoming an increasing problem in America, Idorsia is hopeful that the DEA will consider de-scheduling the DORA class as it is critical in preventing the overuse of other medications, which are frequently abused or misused, to treat insomnia. Learn more. | | | | | | | Follow us on Twitter | | | | Follow us | | | | |
