Currently, cosmetic manufacturers can choose to register their products with the agency voluntarily.īut 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.
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. 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. Members of the Senate HELP committee agreed on legislation, 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. 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.ĬOSMETICS REGULATION OVERHAUL THREATENED BY USER FEE SPAT - The first overhaul of how cosmetics are regulated in the U.S. “What are we telling industry that they have to produce in order to get authorization? And that changes.” “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. 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. “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.įormer FDA commissioner Stephen Hahn says updating Covid-19 vaccine standards makes sense. But an agency spokesperson suggested that instead of using an outside consulting firm to lead the charge, some more familiar faces may be involved. 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. Although the designation will increase the agency’s ability to count cases nationwide, it doesn’t compel states to report the vaccinations they distribute.įDA 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.
1, POLITICO’s Adam Cancryn and Erin Banco report. 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. 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. 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 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. 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. 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. | Francisco Seco/AP PhotoįDA 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. As of today, an additional 780,000 monkeypox vaccines will be made available to states.