| | | | |  | | By David Lim, Lauren Gardner and Katherine Ellen Foley | | | | — CDC's vaccine advisers, Walensky recommend Pfizer booster shots for kids ages 5 to 11. — The House Energy and Commerce Committee approves a reauthorization of FDA user fees, setting up floor debate this summer. — FDA's top two leaders are under fire as the national infant formula shortage continues. It's Friday. Welcome back to Prescription Pulse. Health data should be the subject of more comics, your hosts conclude. 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).
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Kids ages 5 to 11 are now eligible for Covid-19 boosters, which were approved by the CDC on Thursday. | Chip Somodevilla/Getty Images | CDC ADVISERS ENDORSE COVID BOOSTERS FOR KIDS 5 to 11 — Thursday's 11-1 vote (with one abstention) and CDC Director Rochelle Walensky's subsequent formal recommendation of the shots makes the booster available for kids in that age group, Lauren and Katherine report. "Vaccination with a primary series among this age group has lagged behind other age groups, leaving them vulnerable to serious illness," Walensky said. "With over 18 million doses administered in this age group, we know that these vaccines are safe, and we must continue to increase the number of children who are protected." The recommendation came after a debate over how specific members should be: Namely, whether those kids should get their boosters now or as soon as they're eligible, or if they should wait until the fall when a variant-specific vaccination option might be available. Less than a third of children ages 5 to 11 have been fully vaccinated against Covid, but they also have the highest rate of evidence of previous Covid-19 infections of any age group, meaning they may have some level of protection depending on when they were infected. CDC also strengthened its booster recommendations for adults 50 and older and immunocompromised people 12 and older, urging those groups to get another jab at least four months after their first boosters given the steady rise in cases and hospitalizations among older Americans. BECERRA TESTS POSITIVE — Health and Human Services Secretary Xavier Becerra tested positive for Covid-19 Wednesday during a trip to Germany for a G-7 health summit, POLITICO's Sarah Owermohle reports.
| | | | 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. | | | | | | | | E&C COMMITTEE ADVANCES USER FEE PACKAGE TO HOUSE FLOOR — The House Energy and Commerce Committee on Wednesday advanced six bills , including its user fee and mental health packages and a bill that would establish the Advanced Research Projects Agency for Health, known as ARPA-H. The FDA's user fee package received unanimous support from lawmakers with a 55-0 vote. In addition to reauthorizing FDA's medical product user fee programs, the bill included a provision that would compel oncology drugmakers to study pediatric combinations of their drugs to better inform labels. Floor timing is murky. E&C Chair Frank Pallone (D-N.J.) told POLITICO he does not know when the full House will consider the user fee package but said, "We're certainly going to try to move quickly." The Senate earlier this week published user fee reauthorization draft legislation , a step he described as a "positive development in terms of our ability to move it." But significant differences between the House and Senate packages will have to be resolved before President Joe Biden receives a final bill to consider signing into law. Committee ranking member Cathy McMorris Rodgers (R-Wash.) said lawmakers "are committed to delivering the user fee agreements on time." The current five-year agreement expires Sept. 30, the end of fiscal 2022.
| | | CALIFF DODGES LAWMAKER INQUIRIES ON FORMULA RESPONSE — FDA Commissioner Robert Califf ducked questions from House Appropriations Committee members Thursday about why it took the agency months to respond to reports of infant illnesses linked to formula made at an Abbott Nutrition plant, POLITICO's Helena Bottemiller Evich and Meredith Lee report. Califf cited FDA's "ongoing investigation" as the reason he couldn't get into more detail, though he signaled he'd be prepared to divulge more next week at a House Energy and Commerce oversight hearing on the matter. "As I've said, we could do better than we did," he said. WOODCOCK DEPLOYED ON FOOD SAFETY — Califf is deploying longtime FDA leader Janet Woodcock to provide strategic support to the agency's food issues, but industry leaders and consumer advocates are panning the decision, POLITICO's Helena Bottemiller Evich reports. An internal memo distributed to FDA staff Wednesday detailed the principal deputy commissioner's new assignment. Woodcock — who led FDA's drug division for years — is being tasked with helping the agency's Center for Food Safety and Applied Nutrition, Office of Regulatory Affairs, Office of Food Policy and Response and Center for Veterinary Medicine. FDA: DRUGMAKERS SHOULD PREP SHORTAGE PLANS — On Thursday, FDA published draft guidance outlining recommendations for drug manufacturers developing and maintaining shortage risk-management plans. "For Americans to have access to an uninterrupted supply of safe, effective and high-quality drugs, all entities involved in the manufacture of a drug should take every step available to reduce risks and threats to the drug supply chain," Center for Drug Evaluation and Research Director Patrizia Cavazzoni said in a statement. FDA LAUNCHING ALTERNATIVE STERILIZATION PILOT FOR 510(k) DEVICES — Sterilizers of 510(k) medical devices on the market might be able to enter a voluntary pilot program FDA is launching that aims to ease the use of alternative sterilization methods to ethylene oxide. The agency already has a similar pilot program for premarket approval devices. "In addition to public health and environmental concerns regarding EtO emissions, FDA recognizes the need to facilitate timely sterilization method changes to keep device supply chain interruptions at a minimum and to facilitate changes to sterilization processes that utilize reduced EtO concentrations or that utilize other sterilization methods," the agency's Federal Register notice states.
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FDA issued new draft guidance that would help ensure the safety of dietary supplement ingredients to better protect consumers. | AP | FDA WANTS TO KNOW MORE ABOUT DIETARY SUPPLEMENT INGREDIENTS — The dietary supplement industry might have a new opportunity to submit required safety information about new dietary ingredients not given to FDA before a product is marketed if a new draft guidance published Thursday is finalized. The agency said it believes the step will help engender more data to protect public health. "The enforcement discretion policy proposed in this draft guidance relates solely to the failure to submit an NDI notification," FDA said in a press release. "For example, it would not extend to NDI-containing dietary supplements that are adulterated for safety reasons or that violate any other regulatory requirements that pertain to dietary supplements."
| | | FDA PROVIDES MINIMAL UPDATE ON VAPE DECISIONS AT E-CIG SUMMIT — Matthew Holman, the director of the Office of Science in the Center for Tobacco Products, didn't provide a substantial update on the agency's progress in deciding the fate of vapes at the one-day E-cigarette Summit on Tuesday. Attendees were hoping for a progress report on the applications of products from major market players, many of which have yet to receive marketing orders or denials. "The bottom line for us is we need to look at the risk and benefits for the entire population," he said, adding that its main goal was "to move the U.S. population away from composite cigarettes." A court-ordered status update sheds a little more light: A week ago, FDA provided its first update to the District Court for the District of Maryland on its progress e-cig applications. The agency identified 240 applications for products made by large vape companies, including Juul, Vuse and NJOY, that had been filed by the September 2020 deadline. Without providing details on when companies would hear decisions, the agency said it expected to have more than half of those applications finished by June 30, 2022. It didn't expect to be completely finished until June 30, 2023. Musings on CTP's process: Speakers at the summit debated the merit of FDA's vape evaluations so far, noting that some research shows they could be useful tools for adults looking to quit smoking. "One thing that really might need to be considered … is whether there are other ways to actually evaluate some products that hold promise and speed up some of the process," said David Ashley, a retired professor in the School of Public Health at Georgia State University and former CTP Office of Science director.
| | | CANSINO GETS WHO GREEN LIGHT — The World Health Organization Thursday issued an emergency use listing for a coronavirus vaccine produced by China's CanSino Biologics, bringing the portfolio of jabs given the green light by the organization to 11, POLITICO Europe's Ashleigh Furlong reports. WTO NEGOTIATIONS OVER TRIPS WAIVER DRAG ON — World Trade Organization Director-General Ngozi Okonjo-Iweala told members of the group's intellectual property panel they must reach a deal on a proposal to waive IP rights to Covid-19 vaccines by the time of the ministerial conference set for mid-June, POLITICO's Doug Palmer writes. Her plea came after the first two days of negotiations showed that the United Kingdom and Switzerland still have reservations about the plan.
| | | FDA on Tuesday published final guidance outlining how it accesses generic drug user fees under the FDA Reauthorization Act of 2017. FDA laid out in final guidance Wednesday how drug and biologic manufacturers can develop container and carton labels that minimize medication errors. FDA on Thursday issued product-specific draft guidances for a variety of drug products. | | | | Follow us on Twitter | | | | Follow us | | | | |
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