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Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy. | | | | | |  | | By Lauren Gardner and David Lim | With Katherine Ellen Foley, Emily Martin and Sarah Owermohle. PROGRAMMING NOTE: Prescription Pulse will not publish on Friday, June 18. We'll be back on our normal schedule on Monday, June 21. Please continue to follow Pro Health Care. | | | — Novavax’s Covid vaccine was 90 percent effective in a late-stage trial, putting it on par with the two mRNA vaccines authorized in the U.S. — The ripple effects of FDA’s Aduhelm approval continue. But it’s unclear how the controversial drug could affect health care costs. — Former FDA chief Stephen Hahn is joining the venture capital group that backed Moderna in its early days. It’s Tuesday, welcome back to Prescription Pulse. Your authors give a warm congratulations to Wasabi, the pekingese and/or dustmop and/or highly-teased blonde wig that won the Westminster Dog Show on Monday. Be sure to send tips to David Lim (dlim@politico.com or @davidalim), Lauren Gardner (lgardner@politico.com or @Gardner_LM) and Katherine Ellen Foley (kfoley@politico.com or @katherineefoley). | | | | DON'T MISS THE MILKEN INSTITUTE FUTURE OF HEALTH SUMMIT: POLITICO will feature a special edition of our Future Pulse newsletter at the 2021 Milken Institute Future of Health Summit. The newsletter takes readers inside one of the most influential gatherings of global health industry leaders and innovators who are turning lessons learned from the past year into a healthier, more resilient and more equitable future. Covid-19 threatened our health and well-being, while simultaneously leading to extraordinary coordination to improve pandemic preparedness, disease prevention, diversity in clinical trials, mental health resources, food access and more. SUBSCRIBE TODAY to receive exclusive coverage from June 22-24. | | | | | | | | NOVAVAX CHECKS IN — The company said Monday that its Covid-19 vaccine was 90 percent effective in a late-stage trial in the U.S. and Mexico, and 100 percent protective against severe illness and death. The vaccine also appeared to perform well against key variants in the 30,000-person trial — including the Alpha variant that first emerged in the U.K. Those results show the vaccine to be only a few percentage points less effective than those from Moderna and Pfizer, and better than the one-dose shot from Johnson & Johnson. Novavax said it will seek FDA authorization for its shot in the third quarter of 2021. A big win for the small biotech: The company’s Covid-19 shot is poised to become its first product to reach market. But there’s a catch: It's not clear whether there will be much demand in the U.S. for the vaccine. The U.S. government has given the company $1.6 billion and reserved 100 million doses, but it already has enough vaccine on order from other makers to cover the U.S. population. The U.S. might end up donating some or all of those Novavax doses as part of its commitment to help countries in need. But the Novavax shot could also be a hot commodity in the booster market alongside shots from Pfizer and Moderna, if and when additional shots are needed to bolster immunity, SVB Leerink analysts wrote in a research note Monday. ANTI-VAX FORCES TALLY STATE HOUSE WINS — The anti-vaccine movement has gained a foothold in more states amid the political polarization that continues to surround the pandemic, Lauren reports. At least half a dozen states have passed laws to limit mandates for Covid shots, and at least 11 have banned the use of vaccine passports. The state-house success comes after some vaccine opponents adopted anti-mask and social distancing stances earlier in the pandemic. Some of the bills don’t stop at Covid — they rein in states’ public-health emergency powers more broadly. Public health officials say that could spell disaster as society reopens and opportunities persist for widespread disease outbreaks, be they from Covid or familiar pathogens like the measles. “We are standing at the precipice of reopening society and causing an epidemic on the heels of a pandemic,” said Erica DeWald of Vaccinate Your Family, a vaccine education group. “All it takes is one case coming in as we reopen our country.” FDA TO J&J: DUMP 60M DOSES MADE BY EMERGENT — Regulators ordered the single-shot manufacturer to scrap the doses after determining they “are not suitable for use,” Erin Banco and Sarah Owermohle report. However, the agency did clear about 10 million doses for use. FDA concluded that the cross-contamination between the J&J shot and the AstraZeneca vaccine, which was also being produced at the same Emergent BioSolutions facility, likely occurred when waste material passed through from the AstraZeneca area, according to a memo about its decision. Those compromised waste flow procedures were in place when five batches were manufactured, which is why the agency ordered so many to be discarded. HHS SHUFFLES COVID-19 TESTING WORKING GROUP LEADERSHIP — The federal official who led the health department’s Covid-19 testing and diagnostic working group for the past seven months is returning to the Centers for Disease Control and Prevention as part of a broader reorganization of the government’s pandemic response, according to emails obtained by POLITICO. Michael Iademarco will be replaced by Dean Winslow, a professor of medicine at Stanford University with expertise in infectious diseases. As part of the leadership shuffle, CDC is deploying Jay Butler — its deputy director for infectious diseases — to the Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response as a senior adviser until Sept. 30. CDC’s Denise Cardo will oversee the agency’s infectious disease portfolio while Butler is at ASPR. | | | FORMER FDA CHIEF JOINS VENTURE CAPITAL GROUP — Oncologist Stephen Hahn becomes Flagship Pioneering’s chief medical officer this week, joining the executive staff of the Massachusetts venture capitalists who backed nascent vaccine maker Moderna more than a decade ago — and has made more than $1 billion off Moderna’s rising stock this past year. The former FDA commissioner has been in talks with Flagship for several weeks, the Washington Post’s Dan Diamond first reported. As Trump’s second FDA chief, Hahn was confirmed to the role roughly a month before the first reported cases of Covid-19 and helmed the agency for just over a year. “The importance of investing in innovation and preemptive medicine has never been more heightened,” he said in a statement about his Flagship role. “The more we can embrace a ‘what if …’ approach the better we can support and protect the health and well-being of people here in the U.S. and around the world.” Hahn is the latest former health official to join private industry after Google named one of FDA’s former top deputies, Amy Abernethy, head of clinical research at life sciences company Verily. | | | David Cummings will serve a four-month detail as acting director of the Professional Affairs and Stakeholder Engagement Staff within CDER’s office of the director. He’s spent the last two years as a senior adviser in the Office of Compounding Quality and Compliance. | | | THE ADUHELM SAGA CONTINUES — FDA’s approval of Aduhelm, a drug from Biogen that targets the brain plaques characteristic of Alzheimer’s disease, has increased pressure on insurers to cover the pricey drug plus related, and expensive, tests. Ballooning costs for CMS: Insurance coverage for the drug, which costs $56,000 annually, isn’t a given. It would almost certainly mean higher premiums for the 56 million older adults. Given the mixed results the drug yielded in Phase III clinical trials, some federal experts aren’t sure that Medicare should even cover it. Yet lawmakers who have been outspoken on lowering the price of drugs previously have remained tight-lipped about the costs of Aduhelm, in fear of dashing the hopes of patients desperate for a treatment, report POLITICO’s Susannah Luthi and Rachel Roubein. Diagnostic costs: Aduhelm is only appropriate for patients confirmed to have Alzheimer’s plaques in the brain. Yet most people living with the disease never receive the costly, confirmatory brain scans. That’s because in 2013, the federal Medicare agency recognized that these scans didn’t change the course of treatment, which is typically oral medications prescribed by a primary care physician. Aduhelm’s approval may change that, as drug companies and states pressure the federal agency to reconsider. An FDA advisory panel member speaks out: Despite last week’s rash of resignations from the external advisory committee that recommended against the drug’s approval, one member told Prescription Pulse he’s staying. Caleb Alexander, a professor of epidemiology and medicine at the Johns Hopkins Bloomberg School of Public Health, said he respects his colleagues’ decisions to leave the panel and called FDA’s process for considering aducanumab “highly befuddling.” FDA missed an opportunity to engage the committee on the suitability of pinning the conditional approval on plaque reductions observed in trial patients, Alexander said. “The medical reviewers had exceptional enthusiasm for this product from the start that far exceeded the totality of scientific evidence to support it,” he said. “And I think that’s the billion-dollar question: Why?” FTC SETTLES WITH PROMOTER OF SHAM COVID TREATMENT — The Federal Trade Commission has settled with a California company’s medical director for hawking a bogus $23,000 Covid-19 “treatment.” Stephen Meis must pay more than $100,000 in refunds to consumers and is prohibited from “making similar unsupported health claims in the future,” the agency said Monday. | | | | SUBSCRIBE TO WEST WING PLAYBOOK: Add West Wing Playbook to keep up with the power players, latest policy developments and intriguing whispers percolating inside the West Wing and across the highest levels of the Cabinet. For buzzy nuggets and details you won't find anywhere else, subscribe today. | | | | | | | | Paul Burton will become Moderna’s chief medical officer next month. He’s worked at Johnson & Johnson for 16 years, most recently as chief global medical affairs officer of Janssen Pharmaceuticals. DLA Piper announced today it is formally launching a life sciences policy and regulatory practice led by Jim Greenwood and Geoffrey Levitt. Greenwood, a former congressman, previously worked as the CEO of BIO. Levitt previously worked as a senior vice president at Pfizer. | | | G-7 LEADERS PLEDGE VACCINES TO DEVELOPING WORLD — Leaders of the G-7 group promised to send 870 million doses of coronavirus vaccines to the developing world over the next year, POLITICO EU’s Carlo Martuscelli reports. The doses would be made available "as soon as possible," with at least half coming by the end of the year, channeled through the COVAX vaccine-sharing pool to "those in greatest need," the leaders said in a communiqué at the end of a summit. The U.S. had previously already pledged 500 million doses, with another 100 million coming from the U.K. | | | Here are some highlights from our colleagues over at AgencyIQ, the regulatory insight platform for the FDA. Is the first interchangeable biologic coming soon? — The FDA has never before approved an interchangeable biologic — a biological product that “can be expected to produce the same clinical result as the reference product in any given patient.” The standard is meant to be ever greater than “biosimilar,” which regulators permit to have “minor differences” as long as they are not clinically meaningful. But according to a statement by Viatris, a company formed through the merger of Mylan and Pfizer’s Upjohn unit, it expects two of its insulin products to be approved as interchangeable in July 2021. The products (Insulin Glargine and Insulin Aspart) could have a significant market impact since the FDA has never before approved a “generic” insulin. Harmonization group plans guidance on real-world data — The International Council for Harmonization (ICH), an international regulatory harmonization group whose members include the FDA and other key international regulatory agencies, announced last week that it is working on a new guideline related to pharmacoepidemiological studies that make use of “real-world” data. Pharmacoepidemiology refers to the study of how a drug affects populations, and the ICH guideline would specifically be focused on the collection of real-world safety data. Real-world data generally refers to any source of data collected outside of a clinical trial, such as an electronic health record or patient registry. The harmonized approach could make it easier to use data collected from real-world sources in key regions, including the U.S., Europe and Japan. | | | Doctors are scrambling to figure out how to discuss the uncertainties surrounding aducanumab’s effectiveness with their Alzheimer’s patients, STAT reports. The New York Times spoke with virologist Kristian Andersen, who’s been outspoken about his belief that the novel coronavirus originated in nature — though he shared early suspicions with Anthony Fauci that it may have leaked from a lab. | | | | Follow us on Twitter | | | | Follow us | | | | |  |
