CSPI, Public Citizen on FDA
This article was originally published in The Tan Sheet
Executive Summary
The Center for Science in the Public Interest and Public Citizen assert that the White House and Congress have "hampered the agency," in a June 27 release. The consumer groups charge that the Administration is at fault for causing FDA to be without a permanent commissioner "for roughly 70% of the Bush presidency" and that Congress has "abdicat[ed] much of its oversight responsibility" as well as "slash[ed] the headquarters staffing" of the agency's Center for Food Safety & Applied Nutrition by 11% since 1978. CSPI and Public Citizen point out that FDA's civil servants need more resources to do their jobs effectively and present a litany of concerns about certain agency programs and practices that are under-performing or problematic. Public Citizen cites FDA's lack of enforcement action on companies marketing unapproved nicotine-containing beverages for smoking cessation as dietary supplements and criticizes the drug and device user fee systems. The agency's food-related "failures" include the "misleading" qualified health claims program...
You may also be interested in...
News We’re Watching: AI Safety Partnership; Boston Scientific Recalls; New Cancer, STI Tests; VR
This week, the US and UK announced a partnership to promote AI safety. Boston Scientific recalls embolic agent. LumiCell received FDA approval for its imaging agent to detect residual cancer. Scout receives an award to develop an STI test; and Osso VR leverages the Apple Vision Pro for VR medical training.
Finance Watch: Canaan, Regeneron Reveal New Funds For Start-Ups
Private Company Edition: Regeneron launched a $500m venture fund and Canaan added $100m, bringing the venture firm’s recent total to $1bn-plus. Also, incubators plan to grow over the next decade and in recent financings Avenzo raised $150m and Nvelop launched with $100m.
Pink Sheet Podcast: Leqembi Spending, Woodcock’s Next Act, Pneumococcal Vaccine Development
Pink Sheet editors discuss Medicare spending projections for the Alzheimer’s treatment Leqembi, Janet Woodcock’s new post-FDA role, and ongoing preparations for new pneumococcal vaccines that will reach the market soon.