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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 Carmen Paun
| | |  The House Energy and Commerce Committee, led by Chair Cathy McMorris Rodgers and ranking member Frank Pallone, has pinpointed a number of health policy issues it wants to address this year. | Francis Chung/POLITICO | E&C’s 2024 WISHLIST — The House Energy and Commerce Committee has several health care priorities it wants to get over the finish line this year, according to a GOP committee aide granted anonymity to discuss the panel’s legislative agenda. The list, which the aide cautioned is “nonexhaustive,” includes getting the Lower Costs, More Transparency Act and the Support for Patients and Communities Reauthorization Act — both of which the House passed last month — signed into law. Republicans also want to figure out a way to reauthorize the Pandemic and All-Hazards Preparedness Act, extend the government’s ability to regulate fentanyl-related substances and prohibit federal agencies from using quality-adjusted life years, a metric used to evaluate the cost-effectiveness of drugs and treatments. They also want to develop legislation to address drug shortages and to change how Medicare pays doctors and for medical products. Additionally, the committee wants to address some programs slated to sunset this year if Congress does not take action, including powers from the Building Our Largest Dementia Infrastructure for Alzheimer's Act, the Traumatic Brain Injury Program Reauthorization Act and the Congenital Heart Futures Reauthorization Act. IT’S FRIDAY. WELCOME BACK TO PRESCRIPTION PULSE. We look forward to not driving in or around Washington this weekend. Send news and tips to Lauren Gardner (lgardner@politico.com or @Gardner_LM) or David Lim (dlim@politico.com or @davidalim).
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Because the coronavirus mutates so quickly, it's difficult to create a monoclonal antibody with mechanisms that can adapt to protect against several variants. | NIAID-RML via AP | EUA PURSUIT FOR COVID PREVENTION DRUG — Pharma company Invivyd has asked the FDA to grant emergency use authorization for a prophylactic Covid-19 monoclonal antibody geared toward people with compromised immune systems. If green lit, the drug, VYD222, would be the first preventive treatment for Covid since the agency restricted the use of AstraZeneca’s Evusheld nearly a year ago after the agency determined the drug would not help patients infected with variants circulating at the time. The only antibody authorized for use, Gohibic, is intended to treat certain people with Covid who are hospitalized. How does VYD222 work? The monoclonal antibodies that secured EUAs in 2021 and 2022 couldn’t keep up with the ever-mutating virus. Invivyd’s drug attempts to target areas of the coronavirus that are less likely to change over time in the hope of increasing its effectiveness, CEO Dave Hering told Prescription Pulse. But Invivyd’s goal is to license a platform — as opposed to a single drug — that it could update as the virus evolves, Hering said. The company believes it can predict and model how the coronavirus might change, he said, and has a pipeline of antibodies based on millions of existing viral sequences. What’s next: It’s unclear when the FDA might decide whether to approve VYD222. An agency spokesperson declined to comment, citing federal disclosure laws.
| | | | POLITICO AT CES® 2024: We are going ALL On at CES 2024 with a special edition of the POLITICO Digital Future Daily newsletter. The CES-focused newsletter will take you inside the most powerful tech event in the world, featuring revolutionary products that cut across verticals, and insights from industry leaders that are shaping the future of innovation. The newsletter runs from Jan. 9-12 and will focus on the public policy-related aspects of the gathering. Sign up today to receive exclusive coverage of the show. | | | | | | | | | PARTNERING TO FIGHT FAKE DRUGS IN AFRICA — A top health official in Djibouti hopes that a partnership with French pharma company Sanofi can help the country increase access to drugs for chronic diseases and root out counterfeit medicines, Carmen reports. People turn to counterfeit drugs when they are easily available and cheaper than legitimate ones, said Deka Ahmed Robleh, managing director of Djibouti’s national social security fund. Late last year, Sanofi delivered to the small East African country enoxaparin sodium, an injectable drug used to prevent and treat blood clots, which can reduce the risk of a stroke or heart attack. The delivery was the first under a 2022 Sanofi initiative to provide 30 drug types to 40 countries with the highest unmet medical needs under a not-for-profit brand named Impact. The drugs are for diabetes, cardiovascular diseases, tuberculosis, malaria and cancer, according to Sanofi. The Sanofi initiative also includes training local health care professionals to treat patients with these diseases, which are becoming more widespread in Africa but often go undiagnosed due to the lack of capacity in local health systems. Sanofi makes a small margin from selling the drugs, which is used to fund worker training and other improvements to the health systems in the beneficiary countries, said Jon Fairest, head of Sanofi’s global health unit.
| | U.S. SPEND ON IRA DRUGS OUTPACES OTHER NATIONS — The U.S. pays more than other rich countries for the vast majority of the drugs CMS selected in August for Medicare price negotiations, according to a new Commonwealth Fund analysis released Thursday. CMS is slated to send initial price offers to the makers of the drugs by Feb. 1. Congress directed CMS in the Inflation Reduction Act to negotiate the prices Medicare pays for a small number of drugs slated to grow over time. The analysis, based on data from research firm IQVIA, shows that listed retail prices in the U.S. for the 10 drugs are “on average, three times higher” than they are in other high-income countries such as Germany, Japan and Switzerland.
| | CALIFF HITS CES — FDA Commissioner Robert Califf is slated to appear at the Consumer Electronics Show in Las Vegas this month to discuss the agency’s priorities for regulating artificial intelligence in health care. King & Spalding attorney Lisa Dwyer, who was an FDA policy adviser and deputy chief of staff during the Obama administration, will interview Califf. Her “money question,” she told Prescription Pulse, is how the FDA will approach regulating tools that use AI and machine learning. Those that have already received agency approval tend to use locked AI algorithms that aren’t constantly learning based on new data, she said. As AI becomes more integrated with health care, she said, the firms that make the tech and the health systems that use it are growing more interested in the FDA’s thinking. Dwyer will also ask Califf about the agency’s new advisory committee on digital health, which seeks members.
| | | | Tune in on Wednesday, Jan. 10, as POLITICO explores Taiwan's upcoming presidential election. Hear from our panel on the potential outcomes to the race and the profound implications for U.S.-China relations depending on who wins. REGISTER HERE. | | | | | | | | | BETTER SCREENING, TESTING FOR TB IN TISSUES — A move to halt the use of tuberculosis-contaminated bone grafts last year prevented up to 53 surgeries using the products, which were linked to one donor, according to the CDC’s latest Morbidity and Mortality Weekly Report. Before public health agency officials could intervene, 36 people underwent surgeries with the contaminated material; five of the patients contracted tuberculosis and two died, the report said. The report's authors, which included CDC and state public health officials, said more measures to shield patients from tissue-derived TB transmission “are urgently needed” following the outbreak, the second one linked to such surgeries since 2021. They should include more comprehensive lab testing of tissue cultures and more stringent screening of prospective donors, the authors said. Taking time: Culture-based testing can take up to eight weeks for final confirmation of infection, they said, but it’s more sensitive than the nucleic acid amplification testing the graft manufacturer used, which didn’t detect TB. Donor information should be more carefully scrutinized to root out those with evidence of sepsis, they said, noting that both donors in the 2021 and 2023 outbreaks showed signs of the complication. | | | | Follow us on Twitter | | | | Follow us | | | | |  |
