| | | | |  | | By Katherine Ellen Foley | | | | — FDA clears the way for additional monkeypox vaccines to arrive in the U.S., the first of which will be made available today. — The first cosmetic regulation in nearly a century could be lost in an ongoing user fee spat. — FDA's chief tobacco scientist to leave for Philip Morris International. It's Friday. Welcome to Prescription Pulse. With my two co-authors out of town, I've recruited a new helper . What she lacks in regulatory intel she makes up for in floof. 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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As of today, an additional 780,000 monkeypox vaccines will be made available to states. | Francisco Seco/AP Photo | FDA CLEARS ADDITIONAL MANUFACTURING SITE FOR MONKEYPOX VACCINE — The Food and Drug Administration cleared an additional facility in Denmark to finish manufacturing monkeypox vaccines, allowing more doses to be distributed and administered across the U.S., your host reports. In an announcement on Wednesday, the agency said it had completed an expedited inspection of Bavarian Nordic's fill-finish plant for the Jynneos vaccine, which is cleared to prevent monkeypox and smallpox. Previously, the vaccine manufacturer had outsourced the process of dispensing the product into vials, but now with the FDA's blessing, the company can finish vaccine production quicker. HHS will make more than 780,000 monkeypox vaccines available to states today: With Bavarian Nordic's production capacity increased, more vaccines will be available to state and local health care providers , POLITICO's Daniel Payne reports. Since May, the U.S. has recorded more than 4,600 cases of monkeypox, 99 percent of which are in people assigned male at birth who have sex with men. HHS Secretary Xavier Becerra told reporters Thursday he is not yet ready to declare monkeypox a public health emergency, though some officials believe the outbreak could spread beyond the MSM community if it is not controlled. Meanwhile, the CDC takes its own actions: The Centers for Disease Control and Prevention is slated to increase its surveillance capacity by making monkeypox a nationally notifiable condition on Aug. 1, POLITICO's Adam Cancryn and Erin Banco report. Although the designation will increase the agency's ability to count cases nationwide, it doesn't compel states to report the vaccinations they distribute. FDA HINTS FORMER AGENCY OFFICIALS WILL PARTICIPATE IN REVIEW — Now that FDA Commissioner Robert Califf has called for an independent review of the tobacco regulation and food safety offices at the agency, the looming question is who will lead the charge. The Reagan-Udall Foundation, the nonprofit created by Congress in 2007 to support the agency's mission and tapped by the FDA to conduct this review, stayed mum on specifics while planning is underway. But an agency spokesperson suggested that instead of using an outside consulting firm to lead the charge, some more familiar faces may be involved. "We anticipate that the evaluation team for Reagan-Udall will include former FDA executives with deep knowledge and organizational experience to lead the reviews," a spokesperson from the agency told Prescription Pulse.
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Former FDA commissioner Stephen Hahn says updating Covid-19 vaccine standards makes sense. | Graeme Jennings via Pool | HAHN: UPDATING COVID VACCINE STANDARDS MAKES SENSE — The FDA's evolving approach to its expectations for Covid-19 vaccines is fitting given the changing state of the pandemic, former commissioner Stephen Hahn told David in a recent interview. "The bottom line is that because we're in a different phase, because we're seeing differences in the variants, those guidance documents have to change and the interactions with industry have to change," Hahn said. "What are we telling industry that they have to produce in order to get authorization? And that changes." Though he and Califf have "substantive policy differences," the two share a commitment to "protecting the role of science and data decision-making," according to Hahn.
| | | COSMETICS REGULATION OVERHAUL THREATENED BY USER FEE SPAT — The first overhaul of how cosmetics are regulated in the U.S. since the 1930s was tucked neatly away in the must-pass Senate bill reauthorizing Food and Drug Administration user fees, and it may be scrapped over partisan fights, Lauren reports. Members of the Senate HELP committee agreed on legislation, S. 4348 (117), which would grant the FDA authority to order mandatory recalls of products it suspects are adulterated or misbranded and to issue good manufacturing practice regulations that would allow the agency to inspect records. The bill also would require cosmetics manufacturers to register their facilities with the FDA and report serious adverse events to regulators while keeping records of those events for six years. Currently, cosmetic manufacturers can choose to register their products with the agency voluntarily. But the FDA's ability to regulate cosmetics is in danger because of disagreement over certain other riders attached to the user fee package, which helps fund nearly half the agency's annual budget. If the package falls through, some lawmakers fear that cosmetics with potentially dangerous contaminants will remain on the market. SENATE DEMS RELEASE FY2023 FDA BUDGET — On Thursday, Democrats on the Senate Appropriations Committee debuted all 12 of their annual spending bills to fund the government in fiscal 2023, proposing a more than 10 percent increase in nondefense spending and a nearly 9 percent boost in defense funding, POLITICO's Jennifer Scholtes reports. Estimated funding for the FDA would be more than $3.6 billion. But the rollout isn't expected to push Congress any closer to passing a bipartisan funding package before the next government shutdown deadline on Sept. 30. Without a cross-party agreement on overall totals and controversial policy issues, Republicans forecast a continuing spending resolution that keeps the government running on static funding levels well beyond the Oct. 1 start of the new fiscal year.
| | | | 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 . | | | | | | | | DRUGMAKERS WAGE 'HAIL MARY' CAMPAIGN TO SINK RECONCILIATION BILL — For the pharmaceutical players, the newly revived budget reconciliation bill is a five-alarm fire , POLITICO's Megan Wilson reports. The bill includes provisions that would allow Medicare to negotiate prices of some of the most costly drugs used by America's older adult population and punish drug companies if they raise prices faster than the rate of inflation. After Senate Majority Leader Chuck Schumer and Sen. Joe Manchin (D-W.Va.) revived it with the announcement of an agreement Wednesday, it appears that the bill is gaining momentum again. Lobbyists for pharmaceutical groups are flocking to Capitol Hill in a desperate attempt to undermine the bill, which could lose their clients millions. "The ground is shifting. It's starting to sink in for them, what the bill does," one industry lobbyist told Megan about the sentiment among pharmaceutical executives at a recent gathering. "The CEOs who have significant concerns are very engaged."
| | | FDA CHIEF TOBACCO SCIENTIST TO EXIT — Less than a month after the start of a new director for the FDA's tobacco regulatory division, its chief scientific officer has resigned to accept a position at tobacco giant Philip Morris International, I report. In a staff memo sent Tuesday, Brian King, the director of the Center for Tobacco Products, told colleagues the news that Matthew Holman, a biochemist who directed the Office of Science for the past five years, would be leaving the agency. Holman had been on leave before King took office earlier this month, King explained, and he had recused himself from FDA work while exploring other employment options. Philip Morris International wouldn't comment on the role Holman was taking at the company but said it would be announced at a later date. As the agency searches for a new permanent director, Todd Cecil, the deputy director for Regulatory Management, and Benjamin Apelberg, the director of the Division of Population Health Science, who both work in the CTP's Office of Science, will serve as interim directors on a rotating basis. Cecil will take on the first rotation. FDA PROVIDES MEAGER UPDATE ON VAPE APPLICATIONS — In a court-ordered update submitted to the U.S. District Court of the District of Maryland, the FDA said that the estimates it provided 90 days prior — which suggested the agency would finish reviewing e-cigarette applications from major market players by June 2023 — was still the best forecast it could provide.
| | | WHITE HOUSE SUMMIT ON COVID SHOT'S FUTURE — Academic, industry and government officials took to the stage of a daylong meeting on Wednesday to discuss how the government could foster innovation for Covid-19 vaccines — though members of certain federal agencies were conspicuously absent, your host reports. The meeting was attended by academic, industry and government representatives, but officials from the FDA and CDC, who play key roles in vaccine regulation and distribution, did not appear on panels. An FDA spokesperson noted that while no agency employees spoke at the summit, some staff listened in. The CDC did not respond for comment. The White House had no comment. Much of the discussion was centered on broad, forward-thinking ideas with little concrete action items mentioned. "The Biden administration is committed to doing everything we can to usher in a new set of vaccines, a new set of innovations and technology and the policies that need to go with it," Ashish Jha, the White House Covid-19 response coordinator, said during opening remarks.
| | | Gregory Conley joins the American Vapor Manufacturers Association, an advocacy group for independent vapor manufacturers, as director of legislative and external affairs. He was formerly the president of the American Vaping Association. | | | | Follow us on Twitter | | | | Follow us | | | | |
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