“crows” -Crowd
Lol I was wondering what the view of crows was all about!
FDA Quietly Allows Pharma Firm To Profit Off Life-Saving Diabetes Treatment Right After GOP Proposal To Expand Access
The Food and Drug Administration (FDA) quietly allowed a pharmaceutical firm to profit off a life-saving diabetes treatment, shortly after a group of Republican senators proposed legislation to expand access to the treatment by changing how it is regulated.
The FDA on June 28 gave CellTrans Inc., a pharmaceutical company specializing in cellular therapies, approval to sell Lantidra, a pancreatic islet cellular therapy to treat type 1 diabetes. Republican lawmakers led by Utah Sen. Mike Lee had proposed a bill days earlier to recognize islets as organs instead of drugs in order to make islet therapy more accessible.
“Interestingly, the approval came just six days after we presented the bill, and on the same day we informed the FDA about its introduction,” Lee told the Daily Caller in a statement. “While it’s encouraging that this proposed legislation is spurring action, we have serious concerns regarding the drug framework currently used to regulate islets, as there may be more effective approaches for ensuring patient access and safety.”
Most advanced nations recognize islets as organs and tissue for transplantation instead of a drug, according to a July 2020 paper published in the peer-reviewed American Journal of Transplantation.
If islets were regulated as organs, profiting off the treatment would be illegal under the National Organ Transplant Act passed in 1984. Islets are clusters of cells in the pancreas made up of several different kinds of cells, including beta cells that make insulin, according to the University of California San Francisco. Islets are transplanted when they are removed from the pancreas of a deceased organ donor, purified, processed and transferred to a patient.
https://dailycaller.com/2023/07/17/fda-celltrans-diabetes-treatment-lantidra-lee-bill-access/