|
Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy. | | | | |  | | By Lauren Gardner, Katherine Ellen Foley and David Lim | With Megan R. Wilson
| | | — Emergent BioSolutions announced it received a warning letter from the FDA. — Doctors and nurses are encouraging parents to get their children up to date on vaccinations as the new school year begins — and as routine immunization rates have dipped. — Experts fear that monkeypox could become a permanent fixture in some parts of the LGBTQ+ community. It’s Tuesday. Welcome to Prescription Pulse. Since the Supreme Court overturned Roe v. Wade in June, reports are surfacing of patients — even those not seeking abortion — having trouble filling certain prescriptions and being denied treatment for pregnancy-related complications. Have abortion laws affected your access to health care? We want to hear from you. Send tips and feedback to David Lim ( dlim@politico.com or @davidalim ), Lauren Gardner ( lgardner@politico.com or @Gardner_LM ) or Katherine Ellen Foley ( kfoley@politico.com or @katherineefoley ).
| | | | 
The FDA sent a warning letter to Emergent BioSolutions about problems it found during an agency inspection of a facility. | Tasos Katopodis/Getty Images | EMERGENT DISCLOSES FDA WARNING LETTER — Emergent BioSolutions received a warning letter from the FDA on Aug. 10, the company announced Friday in a financial disclosure . The FDA sends warning letters to manufacturers to compel them to take corrective action to address problems observed during agency inspections not resolved to the FDA’s satisfaction. The warning letter is related to the manufacturer’s Camden facility in Baltimore, which was cited for two deficiencies pertaining to its “systems for cleaning and maintenance of equipment to prevent contamination of drug product, specifically related to particulates from the metal trays” as well as its “practices surrounding aseptic processing.” The company said the FDA recommended the company work with a consultant on its current good manufacturing practices and review its quality management system. “As we discussed on our August 1 earnings call, while waiting for FDA’s response related to the February 2022 inspection of the facility, we retained a third party for additional review of the facility and to provide additional oversight of our processes for product release,” Emergent BioSolutions said in a statement. “As the FDA states in the warning letter, this step is critical to ensuring medically necessary products get to the patients who need them.” The FDA typically posts warning letters on Tuesdays, meaning more information may emerge today about the challenges at the facility. The company’s website says its Camden facility “provides drug product manufacturing for sterile injectables,” but it is unclear what products are potentially impacted by the warning letter. The FDA previously ordered the company to halt production for several months over quality control and contamination issues at its separate Bayview facility in Baltimore related to its difficulties manufacturing Covid-19 vaccines.
| | | |  As kids return to school, health officials are concerned about declining routine childhood immunization rates. | Getty Images | LOW VACCINE UPTAKE SPARKS WORRIES AS STUDENTS RETURN TO SCHOOL — Kids across the country are heading back to classrooms this month and next as polio spreads in at least one major metro area and depressed childhood immunization rates continue to vex public health officials. August is National Immunization Awareness Month, and some health groups are using the occasion to redouble efforts to get kids back on track with routine childhood shots they may have missed when Covid-19 shuttered school doors and made in-person doctor visits less frequent. The National Association of School Nurses is encouraging members to speak with students and their families about the importance of keeping immunizations up to date, said Deborah D’Souza-Vazirani, NASN’s Champions for School Health project manager. Kaiser Permanente has given funding to the group to dole out grants to school nurses and community-based organizations in nine of Kaiser’s markets to increase vaccine confidence, equity and uptake among 5- to 11-year-olds. “We know that our school nurses are trusted messengers,” she said. Interest piqued: Sterling Ransone, president of the American Academy of Family Physicians, said his group is promoting the importance of children getting back on their routine immunization schedules — and of adding Covid-19 shots to that list — through media interviews and op-eds. His practice in rural Virginia is seeing an uptick in parent calls about vaccinations as media reports about polio and monkeypox continue. When asked which diseases tend to be under-immunized right now, Ransone said there’s been “an across-the-board decline,” thanks to the pandemic shifting parents and kids off-schedule. But now that school is set to begin soon, he said, his practice is “absolutely inundated” with patients making sure they’re up to date on the shots they need to attend school.
| | | | DON'T MISS DIGITAL FUTURE DAILY - OUR TECHNOLOGY NEWSLETTER, RE-IMAGINED: Technology is always evolving, and our new tech-obsessed newsletter is too! Digital Future Daily unlocks the most important stories determining the future of technology, from Washington to Silicon Valley and innovation power centers around the world. Readers get an in-depth look at how the next wave of tech will reshape civic and political life, including activism, fundraising, lobbying and legislating. Go inside the minds of the biggest tech players, policymakers and regulators to learn how their decisions affect our lives. Don't miss out, subscribe today. | | | | | | | | PUBLIC HEALTH EMERGENCY WATCH — If states don’t hear from HHS that the federal government plans to end the Covid-19 public health emergency by today, HHS Secretary Xavier Becerra will likely sign another extension come Oct. 15. The Biden administration has said it would give at least 60 days notice before the PHE is terminated, and three people with knowledge of the internal discussions told POLITICO last week the declaration is expected to stay in place beyond the midterms. House Energy and Commerce Committee ranking member Cathy McMorris Rodgers (R-Wash.) and Health subcommittee ranking member Brett Guthrie (R-Ky.) argued last week that the Biden administration “lacks any good justification” to maintain the PHE without providing additional details on how the government will wind it down. NOVAVAX ASKS FDA TO AUTHORIZE BOOSTER SHOT FOR ADULTS — On Monday, Novavax applied for emergency use authorization for its Covid-19 booster shot for adults. If authorized, it would be the first protein-based booster for U.S. adults and could be given to anyone, regardless of the primary series they received.
| | | MONKEYPOX THREATENS TO LINGER IN SOME PARTS OF THE LGBTQ+ COMMUNITY — Experts and activists fear that it may be impossible to stop the spread of monkeypox within certain parts of the LGBTQ+ community — and that it threatens to spill over into other segments of the population, too, POLITICO’s Krista Mahr, Megan Messerly and Katherine report. The Biden administration is optimistic that its strategies will be able to quell the spread. On Monday, HHS officials announced that they would be making 442,000 more doses of the Jynneos vaccine available for states and other jurisdictions to order, speeding up the timeline of their release. States and LGBTQ community leaders, however, feel that the federal government could be doing more than it is to support their efforts to vaccinate those most at risk of contracting the disease. “We’re in this period of time where we still have a shot at it,” John Swartzberg, clinical professor emeritus at UC Berkeley’s School of Public Health, told POLITICO. “I don’t know how fast the door is closing, but it is closing.”
| | | FORMER HEAD OF SCIENCE FOR FDA’S TOBACCO OFFICE ON WHY HE LEFT — Matthew Holman, the former head of the Center for Tobacco Office of Science who recently stepped down to take a job at Philip Morris International, says he remains fully committed to reducing tobacco death and disease. Holman told Katherine his decision to work at the tobacco giant was motivated by this goal: “I wanted a change that would allow me to continue advancing the public health mission of reducing tobacco death and disease, and I felt like PMI was a place where I could continue to do that in a different way than I could at the agency,” he said. “PMI is a stakeholder in the tobacco space and in the tobacco harm-reduction space. I have seen what they’ve been doing over the past couple of years after announcing this very aggressive set of goals that they have [to reduce the sales of combustible cigarettes],” he added, alluding to the company’s goal of having more than half of its net revenue come from non-cigarette tobacco products. FORMER LAWMAKER TO LOBBY FOR ALTRIA — Tobacco giant Altria has hired HHQ Ventures to work on tobacco regulations, with Kevin Yoder, the Republican congressman-turned-lobbyist, working on the company's behalf. Disclosure forms are vague, only saying that he'll be working on the implementation of the Family Smoking Prevention and Tobacco Control Act, an Obama-era law that gave the FDA the authority to regulate the manufacturing, distribution and marketing of tobacco products. Altria has a large stake in e-cig company Juul. In June, the FDA ordered Juul to pull its products from the market, but the decision has been temporarily suspended pending additional regulatory review.
| | | | INTRODUCING 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. | | | | | | | | DEMS CLINCH HEALTH, TAX, CLIMATE DEAL — The House voted along party lines Friday to pass Democrats’ sweeping reconciliation package that would allow Medicare to negotiate certain drug prices, delivering on a key campaign promise of Joe Biden’s presidency and capping more than a year of Capitol Hill negotiations, POLITICO’s Sarah Ferris and Jordain Carney report. While polling shows the bill's health provisions are among its most popular elements, the negotiated prices won't begin to kick in until 2026, making the legislation tricky for Democrats to sell on the midterm campaign trail. Biden will sign the bill, H.R. 5376 (117), into law today.
| | | UK CLEARS FIRST OMICRON-SPECIFIC COVID-19 VACCINE — The U.K. became the first country to green-light a Covid-19 vaccine that targets the Omicron variant, POLITICO’s Helen Collis reports. The vaccine, made by Moderna, targets both the BA.1 Omicron variant as well as the original virus. It will be available in the fall. | | | | Follow us on Twitter | | | | Follow us | | | | |  |
