| | | | |  | | By Lauren Gardner and David Lim | With help from Ruth Reader
| | |  Vaccine safety experts say more safety surveillance and research could help gain the trust of people who fear, or who have had adverse effects from, vaccinations. | Chandan Khanna/AFP via Getty Images | VACCINES AND PUBLIC TRUST — Public trust in the benefits of vaccination remains an issue as the world emerges from the Covid-19 pandemic, and a group of vaccine safety experts this week renewed their plea for more funding for safety surveillance efforts they say could help shore up confidence. “Typically what gets funded is what science and medicine thinks is important, and typically, what the public thinks — what the public is concerned about — is not top on the mind of an NIH subsection,” Dan Salmon, director of Johns Hopkins’ Institute for Vaccine Safety, said during a panel discussion at the annual World Vaccine Congress in Washington. “It's one of the reasons why science and the public are becoming more and more polarized. … We're not doing the science the public wants.” Public policy has focused on the vast majority of vaccine recipients who respond well to immunization — they’re adequately protected from disease and experience minimal to no side effects, said Bob Chen, scientific director of the Brighton Collaboration, a vaccine safety research network. But the minority land on either end of that “bell curve,” as Chen described it — they either underrespond and need repeated vaccinations, like people who have weak immune systems or are older, or they overrespond and have moderate-to-severe side effects, like Guillain-Barré syndrome or myocarditis, which have been associate with flu or Covid shots. Patient voices: While rare disease advocates rely on patients to push for pharma companies and government attention to their causes, Chen said, the “immunization establishment” has been reluctant to involve people injured by vaccines to be part of the conversation around how to study safety. “We’ve driven our consumer group away from us,” he said, nodding to the National Vaccine Information Center, which was founded by parents who believed vaccines injured their children. The original group helped negotiate the parameters of the 1986 law that established the Vaccine Injury Compensation Program. It now lobbies to make it easier for parents to opt out of routine childhood immunizations that public health experts fear could lead to more spikes in diseases like measles that were once considered under control. Vaccine safety scientists need to overcome their discomfort, Salmon said, because they’re “unable to have a group of advocates that go to the Hill and get funding, and us being unwilling to articulate a problem because the short-term impact is it will scare people.” IT’S FRIDAY. WELCOME BACK TO PRESCRIPTION PULSE. Is the sun playing coy until Monday’s eclipse? Send news and tips to Lauren Gardner (lgardner@politico.com or @Gardner_LM) or David Lim (dlim@politico.com or @davidalim).
| | |  Dr. Peter Marks, who heads the FDA's Center for Biologics and Evaluation Research, says the FDA and the CDC won't continue to work at the same pace it did during the pandemic's height. | Getty Images | VACCINE CONGRESS TAKEAWAYS — Lauren attended the World Vaccine Congress in Washington and caught panels featuring FDA and CDC officials, pharma companies and academics that focused on lessons we’re still learning from the Covid pandemic and what the future of vaccine development looks like. One theme that emerged from several of those sessions: Don’t expect the agencies to continue operating at the pace they did during the public health emergency. “That’s not something that’s sustainable in nonpandemic times,” said Dr. Peter Marks, director of the FDA’s Center for Biologics and Evaluation Research. And while the CDC’s independent vaccine committee doesn’t plan to hold nearly as many meetings as it did at the pandemic’s height, one change will stick for the foreseeable future — virtual instead of in-person meetings. ALS DRUG PULLED — Amylyx Pharmaceuticals will pull its ALS drug Relyvrio from the market after late-stage trial data showed it doesn’t yield a clinical benefit for patients, Lauren reports. The company will maintain free access for patients who wish to continue taking the drug. The ALS Association applauded the company’s decision in a statement Thursday. “ALS is a fatal and heterogenous disease with few treatment options, and creative solutions are needed,” the group said. “We believe the example of Relyvrio shows how the system can work.” FDA APPROVES AI TOOL FOR SEPSIS — The FDA has authorized the first artificial intelligence diagnostic tool for sepsis, Ruth writes. Prenosis, a Chicago-based health tech company, says what separates its technology from traditional sepsis alert systems is that, instead of continuously monitoring for sepsis or its signs, it creates an on-demand risk score for the patient. Doctors must order an assessment as they would any other lab test. The product’s AI will suggest that a doctor order additional tests if it thinks the data is insufficient to issue a score. A third of people who die in hospitals have sepsis, an extreme immune response to infection that can be fatal, the CDC says. Some sepsis AI is already being used without the FDA’s explicit endorsement. Electronic health record system Epic had a sepsis algorithm that came under fire for its questionable accuracy, though it has since been updated.
| | | | YOUR GUIDE TO EMPIRE STATE POLITICS: From the newsroom that doesn’t sleep, POLITICO's New York Playbook is the ultimate guide for power players navigating the intricate landscape of Empire State politics. Stay ahead of the curve with the latest and most important stories from Albany, New York City and around the state, with in-depth, original reporting to stay ahead of policy trends and political developments. Subscribe now to keep up with the daily hustle and bustle of NY politics. | | | | | | | | | BIDEN ADMIN SUED OVER MENTHOL INACTION — A trio of public health groups this week again sued the FDA for not moving forward with restrictions on the sale of menthol cigarettes. The African American Tobacco Control Leadership Council, Action on Smoking and Health and the National Medical Association argue the agency has unreasonably delayed issuing its final rule. The Biden administration missed a self-imposed March deadline to release it and the rule to ban menthol cigarettes and flavored cigars has been under review at the White House for nearly seven months. On Thursday, the White House did not respond to questions about when it might release the rule, and the FDA said the ban is a priority as it has said in the past. COMPOUNDERS SUE FDA — Three Texas health care providers sued the FDA this week over the agency’s ban on compounding certain peptides into custom therapies. Peptides are amino acid strings used to produce supplements in pill form, among other uses. The providers claim that the FDA’s inclusion of certain peptides on the do-not-compound list under its interim policy on compounding with bulk drug substances is “arbitrary and capricious” because the agency didn’t go through notice-and-comment rulemaking. The agency does not comment on pending litigation.
| | OVERSIGHT BRINGS IN CALIFF — FDA Commissioner Robert Califf will testify Thursday before the House Oversight Committee on several issues, including food safety, drug shortages, inspections, hemp and tobacco regulations and the questionable effectiveness of over-the-counter decongestants, Chair James Comer (R-Ky.) said Thursday. "From a botched response to a nationwide infant formula crisis, failure to regulate safe tobacco products, failure to prepare for and address critical drug shortages, and more, we have identified how dysfunction at the FDA could be worsening many of these preventable crises," Comer said.
| | TRUMP’S DRUG-PRICING PLAN — Former Trump administration health officials say they have spent time working on a more legally defensible version of a stymied policy that sought to allow Medicare to pay no more than other developed nations for 50 drugs administered by doctors, such as cancer drug infusions. "Those people who were committed to addressing that inside the administration in term one have had four years to think about it and be creative and maybe expand their thought process on how to address the legal deficiencies and deploy other tools that maybe hadn't been considered at the time,” Joe Grogan, the former president’s domestic policy adviser, said. The Trump campaign confirmed the plan is on the agenda if the presumptive GOP nominee wins in November. But details are hard to come by as the pharma industry is likely to mount a legal battle and could make use of any specifics on how a Trump administration plans to make it work.
| | Anthony Wright will join health care advocacy group Families USA as executive director in July. He’s currently executive director of Health Access California. Dr. Anthony Fauci, former director of the National Institute of Allergy and Infectious Diseases, was appointed a distinguished senior scholar at Georgetown Law’s O’Neill Institute for National and Global Health Law.
| | The Federal Trade Commission released a report on e-cigarette sales and advertising Wednesday, which found that combined sales of cartridge-based and disposable products to U.S. consumers increased by about $370 million between 2020 and 2021, with the total nearing $2.7 billion. The FDA issued 119 warning letters and 41 civil money penalty complaints against brick-and-mortar retailers selling Zyn nicotine pouches to underage customers.
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