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Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy. | | | | |  | | By David Lim and Katherine Ellen Foley | | | | | 
Sens. Bernie Sanders (right) and Bill Cassidy (left) released a discussion draft on reauthorizing the Pandemic and All-Hazards Act. | Chip Somodevilla/Getty Images | PAHPA DRAFT DROPPED — Divergent views over drug pricing policy remain sticking points in the Senate’s effort to revamp the pandemic preparedness law, according to draft text from the Senate HELP Committee, David and POLITICO’s Megan R. Wilson report. The otherwise bipartisan draft, released Monday by Chair Bernie Sanders (I-Vt.) and ranking member Sen. Bill Cassidy (R-La.), would reauthorize the Pandemic and All-Hazards Act, originally signed into law in 2006. The panel seeks comments on the 80-page draft by Monday morning. The two lawmakers hope to mark up the legislation this month. Dueling policy wishlist: Sanders wants to cap the U.S. cost for any product supported by the Biomedical Advanced Research and Development Authority or the CDC “at the lowest price among G7 countries” — Canada, France, Germany, Italy, Japan, the U.K. and the U.S. — “at a reasonable price.” And Cassidy wants a reauthorization and expansion of an FDA policy meant to encourage development of medical countermeasures known as the priority review voucher programs. Bipartisan priorities going forward: The Senate discussion draft includes new policies not in the law, including efforts to boost research into wastewater surveillance for pathogen detection and Covid-19’s long-term health effects. It also proposes a pilot program that aims to improve data-sharing among local, state and federal government health agencies and provisions to help individuals with disabilities during emergencies. IT’S WEDNESDAY. WELCOME TO PRESCRIPTION PULSE. Send news, tips and icy pops to David Lim (dlim@politico.com or @davidalim) or Katherine Ellen Foley (kfoley@politico.com or @katherineefoley). TODAY ON OUR PULSE CHECK PODCAST, host Kelly Hooper talks with Robert King, who explains how CMS negotiations with manufacturers over drug prices for Medicare patients will proceed now that the agency’s final guidance has been unveiled.
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Merck and Bristol Myers Squibb are suing the federal government over a plan to negotiate Medicare drug prices. | Matt Rourke/AP Photo | MEDICARE NEGOTIATION PLAN FINALIZED — Drugmakers suing the Biden administration over the Inflation Reduction Act’s drug price negotiation program say concessions in CMS’ finalized implementation plan are not enough to convince them to withdraw legal challenges. “We are reviewing the guidance, but it does not and cannot cure the fundamental constitutional problems with the statute,” Robert Josephson, Merck’s executive director of global media relations, said in a statement. The government’s decision to step back from a draft requirement that drugmakers not disclose information about the drug price negotiation process comes after complaints from the drug industry that the policy may violate the First Amendment. The agency also removed the confidentiality policy’s data destruction requirements. “We believe CMS guidance cannot correct constitutional flaws in the Inflation Reduction Act, including the program that requires pharmaceutical companies like BMS, under the threat of significant penalties, to sell innovative medicines at government-dictated prices,” a Bristol Myers Squibb spokesperson said in an email. Orphan drugs: The government also clarified that drugs marketed for more than one rare disease or condition will not be exempted from the program under the orphan drug exclusion but stated that CMS will consider only active designations and approvals. That means firms might be able to ask the FDA to withdraw a drug indication or designation to avoid being subject to price negotiations.
| | | | SUBSCRIBE TO POWER SWITCH: The energy landscape is profoundly transforming. Power Switch is a daily newsletter that unlocks the most important stories driving the energy sector and the political forces shaping critical decisions about your energy future, from production to storage, distribution to consumption. Don’t miss out on Power Switch, your guide to the politics of energy transformation in America and around the world. SUBSCRIBE TODAY. | | | | | | | | | BREAKING SOCIAL (MEDIA) NORMS — A federal judge in Louisiana ruled Tuesday that the Biden administration’s efforts to influence social media posts about Covid-19 likely violated the first amendment, POLITICO’s Matt Berg and Josh Gerstein report. The Trump-appointed U.S. District Court judge, Terry Doughty, called the administration’s efforts “Orwellian,” issuing a sweeping preliminary injunction that bars a number of federal officials — like Surgeon General Vivek Murthy and HHS Secretary Xavier Becerra — from having any contact with social media firms to discourage or remove First Amendment–protected speech. The judge’s decision cites a wide range of health topics that he says “were suppressed” on social media at the urging of administration officials, including opposition to Covid vaccines, masking and lockdowns — and the lab-leak theory. The decision comes at a critical moment for communicating health care issues to the public as federal officials and public health experts try to take lessons learned from the pandemic and turn them into actionable policy — including faster communication and more targeted messaging. The ruling is a blow to the administration’s efforts to implement those policies — as it is to its approach through the pandemic, which it defended as putting Americans’ health and safety first. Republicans might also see the ruling as a validation of their attacks on the administration’s efforts to sway the public’s discourse on Covid.
| | | | LOOMING LEQEMBI DECISION — The FDA is slated to make a final call on whether Leqembi — an Alzheimer’s drug from Eisai and Biogen that appears to moderately slow the disease — receives traditional approval by the end of Thursday. The FDA granted Leqembi accelerated approval in January, and the agency’s expert advisory panel unanimously endorsed full approval for the drug last month. Though the FDA doesn’t always follow its advisers’ guidance, it often does. The bigger question is coverage: Even with traditional approval, the Centers for Medicare and Medicaid Services has limited coverage of Leqembi — and other drugs like it — to patients whose doctors enroll them in a registry to track their progress. The agency has said it would provide a free national registry free and only ask questions health care providers would be assessing as part of routine care. But at $26,500 annually, disease advocates fear that even the smallest additional burden on doctors could unnecessarily limit the number of patients who will receive Leqembi. “Our real focus in terms of access is, ‘What does CMS do now?’” Robert Egge, chief public policy officer of the Alzheimer’s Association, told Prescription Pulse. It would be the first time the public could see whether the agency has followed through on its pledge to ensure its registry is easy to use, he added. In the longer term, Egge thinks CMS should reconsider its registry requirement. CMS determined it needed more evidence to cover drugs like Leqembi without restrictions. Since that decision, Phase III trial data from Leqembi has been published. “It is now time to open up a process to consider this substantial new evidence,” he said.
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Philip Morris International chief executive Jacek Olczak says he wants PMI to eventually cease selling cigarettes. | Justin Tallis/AFP/Getty Images | MARLBORO MAKER SMOKE-FREE? — Jacek Olczak, CEO of Philip Morris International, said his objective during his tenure is to eliminate cigarettes from the company’s product line. “It doesn’t make sense” to keep selling cigarettes, including Marlboro, the most popular brand of cigarettes worldwide, he told Katherine. The global tobacco company has indicated that it planned to make more than half of its revenue through smoke-free products, including nicotine pouches, electronic cigarettes or products that don’t burn tobacco, by 2025. So far, those types of products make up about 35 percent of revenue, Olczak said. “If you’re still interested in old technology [like cigarettes], you should only see it in a museum,” he said. Cloudy timeline: Olczak wouldn’t comment on a specific timeline for PMI being 100 percent smoke-free and instead said the conversion would be piecemeal as smoking rates decrease in individual countries.
| | EU SIGNS VACCINE MANUFACTURING CONTRACT — The European Commission has signed a contract with a group of four vaccine producers to reserve vaccine manufacturing capacity in case of future disease outbreaks, POLITICO’s Carlo Martuscelli reports. The deal was signed with U.S. pharmaceutical giant Pfizer, Dutch company Bilthoven Biologicals and Spanish vaccine makers HIPRA and CZ vaccines. It covers enough capacity for 325 million doses a year at a cost of roughly about $174.5 million a year.
| | | | Drugmakers including Sandoz, Boehringer Ingelheim and Samsung launched their biosimilar competitors to AbbVie’s Humira, Endpoints News’ Zachary Brennan reports. Battles with cancer have united former tennis rivals and friends Chris Evert and Martina Navratilova, Sally Jenkins reports for The Washington Post. Now that Maryland’s recreational marijuana legalization has gone into effect, questions remain about whether everyone will benefit equally, Alexander Lekhtman reports for Filter Magazine.
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