| | | | |  | | By David Lim and Katherine Ellen Foley | Programming note: We’ll be off this Monday for Presidents Day but will be back in your inboxes on Tuesday.
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HELP Committee Chair Bernie Sanders wants to look closely at what he calls "unacceptable corporate greed" in the pharma industry. | Scott Applewhite/AP Photo | BERNIE LAUNCHES PHARMA SCRUTINY — Sen. Bernie Sanders (I-Vt.) opened his first barrage against the pharmaceutical industry as the top lawmaker on the Senate HELP Committee, taking to the Senate floor Wednesday to lambast drug executive compensation as “unacceptable corporate greed.” “In 2021, while hundreds of thousands of Americans died from Covid, 50 pharmaceutical executives in just 10 companies made $1.9 billion in total compensation,” Sanders said, referring to a new staff report. The longtime critic of the pharma industry will hold a HELP Committee hearing on March 22 to examine Moderna’s reported plans to raise the list price of its Covid-19 vaccine to a range of $110 to $130 per dose when it is commercialized later this year. The witness list: Moderna CEO Stéphane Bancel will voluntarily appear for the first panel. The second panel consists of three drug-pricing academics: Northwestern University’s Craig Garthwaite, Harvard Medical School’s Ameet Sarpatwari and Columbia Law School’s Christopher Morten. Moderna on Wednesday unveiled a pledge that people in the United States will continue to have access to Covid vaccines “regardless of ability to pay.” White House spokesperson Kevin Munoz told POLITICO the Biden administration maintains its position from last month when press secretary Karine Jean-Pierre described the potential price hike as “hard to justify.” And Moderna’s pledge does not appear to allay Sanders’ disdain for the company and the broader industry. “While Moderna may be a poster child for corporate greed, it is not alone,” Sanders said. IT'S FRIDAY. WELCOME TO PRESCRIPTION PULSE. The Spanish legislature voted yesterday to approve paid menstrual leave for employees with debilitating periods, making it the first country in Europe to do so. Send news and tips to David Lim (dlim@politico.com or @davidalim) or Katherine Ellen Foley (kfoley@politico.com or @katherineefoley). TODAY ON OUR PULSE CHECK PODCAST, host Carmen Paun talks with Katherine Ellen Foley about a panel of outside experts’ recommendation that the FDA approve a nonprescription version of naloxone, an opioid overdose antidote, and its potential impact.
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Advocates are calling for reform to pharmacy benefit managers — and Congressional panels are being led by PBM critics with the power to take action. | Manuel Balce Ceneta/AP Photo | CONGRESS READIES PBM LEGISLATIVE PUSH — Advocates pushing reforms to pharmacy benefit managers hope the stars align on Capitol Hill, and they see some action this Congress as lawmakers long critical of the industry are gearing up for a litany of hearings and legislation, Megan R. Wilson reports. Two major factors are at play: — Under the leadership of then-Speaker Nancy Pelosi (D-Calif.), “all the focus was on manufacturers,” one insurance lobbyist told Megan — but the Inflation Reduction Act’s passage achieved the nearly 30-year goal of Medicare negotiating the price of some drugs: “The decks have been cleared, so there is more of an interest in PBMs,” the lobbyist said. — An increasing number of states are passing laws that take aim at the industry. Nearly every state has at least one PBM-related law on the books, enacting more than 100 in total to date. PBMs argue that their role is misunderstood and they can deliver value for patients by negotiating discounts on drugs and passing on the savings to plans, resulting in lower premiums.
| | | | DOWNLOAD THE POLITICO MOBILE APP: Stay up to speed with the newly updated POLITICO mobile app, featuring timely political news, insights and analysis from the best journalists in the business. The sleek and navigable design offers a convenient way to access POLITICO's scoops and groundbreaking reporting. Don’t miss out on the app you can rely on for the news you need, reimagined. DOWNLOAD FOR iOS– DOWNLOAD FOR ANDROID. | | | | | | | | CMMI WEIGHS TWEAKING PAYMENT FOR ACCELERATED DRUGS — CMS said Tuesday it plans to develop and test three new payment models that aim to boost access to expensive cell and gene therapies, increase access and adherence to widely used generic drugs and incentivize completion of clinical trials for drugs approved under FDA’s accelerated approval pathway. Of note for drugmakers: The Center for Medicare & Medicaid Innovation is considering a mandatory model that would adjust payment for accelerated approval drugs to Medicare Part B fee-for-service providers — to incentivize timely confirmatory trial completion. The model’s goal is to “reduce Medicare spending on drugs that have no confirmed clinical benefit,” according to CMS. “Whether [payments] would go up or down, I think that’s, you know, a design question that we would have to explore as we start developing the model,” Liz Fowler, CMS Innovation Center director, told reporters.
| | | OTC NARCAN APPROVAL RECOMMENDED — On Wednesday, the FDA’s advisory committees on nonprescription drugs and pain medications voted 19-0 to recommend the agency approve an over-the-counter naloxone nasal spray, Katherine reports. The FDA has until March 29 to make a decision; if it follows the advisers’ recommendation, it would be the first time the agency has made naloxone available without a prescription — and a major win for the Biden administration, which has prioritized taking action against the ongoing opioid misuse epidemic. The state of the overdose epidemic in the U.S. is still bleak: The CDC released provisional data this week that showed a 1.2 percent increase in the number of overdose deaths reported between September 2020 and September 2021 — although overdose deaths have steadily declined since the middle of last year. Fentanyl, a synthetic opioid, contributed to this increase. FDA Commissioner Robert Califf on Thursday shared an independent report on the agency’s efforts to combat the opioid epidemic. The report recommends the FDA ask Congress for additional authorities for opioid regulation so the agency could require opioid drug applicants to demonstrate their new products are safer than existing ones. And the report advises the FDA to boost transparency around approval of new opioids. “Our commitment to explore more effective use of our advisory committees to increase transparency regarding opioid analgesics will be a part of a broader internal effort to evaluate how to make the best use of all of our advisory committees,” Califf said in a statement. Lawmakers want to see the feds crack down on countries implicated in the fentanyl trade: At a hearing Wednesday, Senate Foreign Relations Committee Chair Bob Menendez (D-N.J.) and ranking member Jim Risch (R-Idaho) said Wednesday that the Biden administration should impose sanctions on China if it doesn’t crack down on the chemical industry that feeds the fentanyl trade. They also called out Mexico for not doing enough to curtail fentanyl trafficking.
| | | MEDCAC ADVISERS ENDORSE CED SUGGESTIONS — CMS’ Medicare Evidence Development and Coverage Advisory Committee endorsed on Tuesday 17 proposed revisions to the agency’s coverage with evidence development process. The goal is to ensure that studies produce evidence that can demonstrate whether a medical product is reasonable and necessary. The process has drawn fire in recent months after it was used to limit broad Medicare coverage of Alzheimer’s drugs that target amyloid plaques in the brain. Tamara Syrek Jensen, director of CMS’ coverage and analysis group, said the next steps include potentially proposing draft updates to the coverage with evidence-development criteria.
| | | EXCLUSIVE: FORMER TRUTH INITIATIVE COO JUMPS TO ALTRIA — Dave Dobbins, former chief operating officer of the country’s largest nonprofit focused on ending tobacco use and nicotine addiction, will serve as an independent consultant for Altria, one of the largest tobacco companies with a 35 percent stake in the e-cigarette company Juul. “In my heart of hearts, I believe in the mission of harm reduction,” Dobbins told Prescription Pulse. “I really do believe they [Altria] want to move beyond smoking.” Altria also hired Alex Norcia, a news editor at the harm-reduction magazine Filter, as a senior manager for regulatory advocacy.
| | | FDA ADDS ADDITIONAL WARNINGS TO ADUHELM — The FDA updated the label of Aduhelm, an Alzheimer’s drug from Biogen, to include language that the drug may lead to brain bleeds larger than a centimeter in diameter and some patients may experience seizures or difficulty walking as additional side effects from brain bleeds or swelling, Katherine reports. “Since Aduhelm was approved, additional information about Amyloid Related Imaging Abnormalities, including information from quarterly safety reports from Biogen and information from other drugs in the class, has become available,” Michael Felberbaum, a spokesperson for the FDA, said in a statement to POLITICO. RESULTS FOR MRNA FLU VACCINE — Moderna said Thursday that in late-stage clinical trials, its mRNA flu vaccine generated a robust immune response in adults against influenza A viruses, which most often sicken older adults.
| | | The Association for Accessible Medicines announced its 2023 board: Teva’s Christine Baeder will serve as chair, Sandoz’s Keren Haruvi is vice chair and Ajanta Pharma’s Jeff Burd is treasurer.
| | | The Biden administration is working on a plan to keep Covid vaccines, treatments and tests free for the uninsured into 2024, POLITICO’s Adam Cancryn and David report. | | | On Thursday, the FDA published 30 product-specific guidances for developing generic drugs. A study published in JAMA Internal Medicine found that between 2018 and 2021, 10 percent of drugs approved by the FDA were based on clinical trials that did not meet at least one of their primary efficacy endpoints.
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