| | | | |  | | By David Lim and Lauren Gardner | Presented by Idorsia Pharmaceuticals | With Ben Leonard
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| SANDERS AMPS PRESSURE ON CEOs — Senate HELP Chair Bernie Sanders said Thursday he thinks he has the votes, including possible GOP support, to subpoena two drug company CEOs to testify at a hearing on the high costs of their prescription drugs. While the Vermont Independent hedged a bit — “You’re never totally confident of anything,” he said during a press briefing — interviews with Democrats on the Health, Education, Labor and Pensions Committee this week suggest he has the backing of his left-leaning colleagues if the vote slated for Wednesday happens. And Republican Sen. Mike Braun of Indiana hasn’t ruled out voting to subpoena the CEOs. “To me, you’re getting called on the carpet because you’re in an industry that does not embrace free enterprise, competition and transparency,” Braun said. Companies fire back: Johnson & Johnson’s outside counsel blasted the planned vote, arguing the company has cooperated by offering “one of its executives with expertise in the noticed topic” to testify. A Merck spokesperson similarly said the company has proposed sending the head of its U.S. business — offers that Sanders declined. Bristol Myers Squibb has promised to testify if at least one other company executive appears. Despite the posturing, five days are left for Sanders and the companies to reach a detente.
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| | Recap: In November, Sanders and the panel’s Democrats wrote to the CEOs of BMS, J&J and Merck, asking them to appear before the committee to answer questions about prescription drug costs in the U.S., which are much higher than in other developed countries. J&J and Merck have resisted Sanders’ pressure campaign. Both companies have released correspondence between their attorneys and the committee, suggesting his push for the CEOs to come to the Capitol is “retaliation” against them for challenging the first Medicare drug price negotiations in court. “This is absurd,” Sanders said. “These companies have every right to file a lawsuit against the administration.” Dem download: Committee Democrats suggested to Lauren that they’re sympathetic to Sanders’ effort, indicating he’ll have the needed support if the subpoena vote is held. “It’s an honor to be asked to testify before a Senate committee. You should come voluntarily, and I have given that advice to the CEOs,” Sen. Tim Kaine (D-Va.) said. IT’S FRIDAY. WELCOME BACK TO PRESCRIPTION PULSE. We welcome the warmer weather. 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. | | | | | | | 
Illinois is being sued by a generic drug trade group challenging a law that would keep generic drug prices in check. | Julio Cortez/AP | GENERICS LOBBY TARGETS ILLINOIS PRICE LAW — A generic drug trade group filed a lawsuit this week in federal district court to try to block an Illinois law aimed at reining in steep increases to the prices of off-patent drugs. The Association for Accessible Medicines argues that the state law, which went into effect Jan. 1, illegally regulates interstate commerce since drug manufacturers are located across the country and sell to wholesalers in different states. The law prohibits price gouging — when the list price exceeds $20 for a 30-day supply and results in at least a 30 percent increase within a year — of certain generic drugs considered essential for treating life-threatening or chronic conditions. The Illinois Attorney General’s office did not respond to an email request for comment. The pharma industry has successfully challenged similar state laws in the past several years, and AAM most recently won its effort to halt the implementation of Minnesota’s generic pricing statute.
| | | | A message from Idorsia Pharmaceuticals:   | | | | | DRUG SHORTAGE PAPER RELEASED — Top lawmakers on the Senate Finance Committee said Thursday they are exploring developing a slate of policies this year to address drug shortages. Committee Chair Ron Wyden (D-Ore.) and ranking member Mike Crapo (R-Idaho) said in a joint white paper they are weighing Medicare payment tweaks to stabilize the supply of generic sterile injectable medicines and incentives to doctors and supply-chain players to maintain a buffer of medicines. They’re also considering creating pilot programs in Medicare Part D to reward pharmacies when they buy generic drugs from companies that invest in shortage mitigation and quality manufacturing. They are also examining whether changing the Medicaid Drug Rebate Program can help prevent generic drug shortages. “Addressing the generic drug shortage crisis in Oregon and across America is urgent business, and Ranking Member Crapo and I are firmly committed to using the power of Medicaid and Medicare to do just that,” Wyden said in a press release. BILL SEEKS MORE ACCESSIBLE DEVICES — A bipartisan duo of senators unveiled a bill this week that would direct the FDA to create regulations requiring new home medical devices, such as glucose monitors and insulin pumps, to be accessible for users who are visually impaired. The bill — led by Sens. Maggie Hassan (D-N.H.) and Mike Braun (R-Ind.) — omits requirements on devices if it would involve a change to “the fundamental nature of the device.” “Almost all smartphones and computers include accessibility features that make it easier for visually impaired people to use them, but home medical devices — which people often need to live — rarely include this basic functionality,” Hassan said of the bill. It is unclear whether there is a moving legislative vehicle that the bill could hitch a ride on.
| | | | JOIN 1/31 FOR A TALK ON THE RACE TO SOLVE ALZHEIMER’S: Breakthrough drugs and treatments are giving new hope for slowing neurodegenerative diseases like Alzheimer’s disease and ALS. But if that progress slows, the societal and economic cost to the U.S. could be high. Join POLITICO, alongside lawmakers, official and experts, on Jan. 31 to discuss a path forward for better collaboration among health systems, industry and government. REGISTER HERE. | | | | | | | | | WILL HELIUM SALE SQUEAK THROUGH? The health care and gas industries are calling for a delay in an impending sale of the Federal Helium Reserve, Ben reports, citing production concerns that could upend the supply chain and harm patients. Helium plays a major role in health care technology, cooling the magnets in MRI machines and supporting ventilator use. Congress directed the Texas-based reserve’s wind-down decades ago, and the Biden administration has taken steps to proceed with the sale, opening bids on Thursday. A spokesperson for the Interior Department, which operates the reserve, said privatization isn’t expected to “meaningfully change” helium availability. PHARMA INDUSTRY STABLE, REPORT SAYS — The global pharmaceutical industry should have “healthy revenue growth through 2027” despite headwinds from cheaper biosimilar competition and the impact of Medicare price negotiations in the U.S., a new report from S&P Global Ratings found. “While we believe the successful passage of the [Inflation Reduction Act] indicates the industry's influence over lawmakers has waned, we believe most lawmakers significantly value the social benefits of advances in medicine and understand the high level of investment needed to generate those innovations,” the report states.
| | | | 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. | | | | | The FDA has renewed the charter for its vaccine advisory committee through 2025. A group of 14 bipartisan senators wrote to President Joe Biden on Thursday, urging him to reject the World Trade Organization’s proposal to waive intellectual property protections for Covid-19 therapeutics and diagnostics.
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