Just after a group of Republican senators proposed legislation to change regulatory practices and expand access to treatment, the Food and Drug Administration quietly allowed drug companies to profit from life-saving diabetes treatments. bottom.

FDA on June 28, Celltrans Co., Ltd.a pharmaceutical company specializing in cell therapy, approval It markets Lantidra, an islet cell therapy that treats type 1 diabetes. A few days ago, Republicans, led by Utah Senator Mike Lee, proposed a bill that would recognize islets as an organ, not a drug, to make islet treatments more accessible.

“Interestingly, we received approval just six days after we submitted the bill, and notified the FDA of its implementation the same day,” Lee told the Daily Caller in a statement. “While it is encouraging that this bill encourages action, there may be more effective approaches to ensuring patient access and safety, and the current use of islet regulation to We have serious concerns about the pharmaceutical framework.”

“Therefore, we are actively working with the Department of Health and Human Services and the Food and Drug Administration for further clarification and information on this issue,” he added. (Related: Exclusive: Republican Senator Asks Biden Justice Department for Answers on CCP Intel-Related “Service Centers”)

4. But what I find particularly irritating is that the FDA is treating pancreatic islet cells as a “medicine” rather than a natural organ. As a result, as with any “new drug”, it will take forever to advance this new treatment option. But it’s not a drug!

— Mike Lee (@BasedMikeLee) April 27, 2023

Most developed countries recognize islets as organs and tissues for transplantation rather than drugs. according to be Paper published in July 2000 It was published in the peer-reviewed New England Journal of Medicine.

If islets were regulated as organs, it would be illegal under the law to benefit from their treatment. National Organ Transplantation Act Pancreatic islets are beta cells that produce insulin, according to University of California San Francisco. Pancreatic islets are removed from the pancreas of a deceased organ donor, purified, processed and transplanted into the patient.

Republican senators introduced Lee of Utah, Budd of North Carolina, and Blackburn of Tennessee law In June, Republican Montana Rep. Matt Rosendale introduced a companion bill to the House to update the island regulations in the Senate.

“This bill has great potential for people living with this chronic disease and offers the possibility of reducing or eliminating the need for insulin injections,” said Senator Lee. press release.

“By redefining islets as organs rather than drugs, we aim to align our regulatory framework with scientific advances in this field. may improve outcomes and quality of life for people with type 1 diabetes,” Lee added.

Leading Scientist in the Transplant Community approved Republican Bill Involving University of Chicago Professor and Islet Transplant Expert Peter Witkowski. (Related: Alzheimer’s drug Rekumbi gets full FDA approval despite risks)

“The problem is that this [profit] Management company [the] The whole field of islet transplantation,” he told the caller. “Decisions may be profit-based rather than based on the patient’s best interests.”

“It is very disappointing that islets have been approved as a drug against the advice of the entire transplant community warning that it is very political and very bad for patients,” he added.

The American Society of Transplant Surgeons, the American Society for Transplantation, the Eyelet for US Collaborative, the American Diabetes Association, and The Cure Alliance are among the scientific groups supporting Republican bills that would change the way pancreatic islets are regulated.

14. Currently, the FDA regulates islets as a new drug, which imposes clinical trial and manufacturing requirements. The United States is unique in regulating islands as drugs. Many other countries, including Canada, the United Kingdom, France, Italy, Australia, and Japan, regulate them as organs.

— Mike Lee (@BasedMikeLee) April 27, 2023

The FDA has approved Lanthidra for adults with type 1 diabetes who suffer from hypoglycemia despite intensive insulin therapy. According to the FDA, Lantidra’s safety was evaluated based on two non-randomized trials involving 30 people with type 1 diabetes and unaware hypoglycemia, in which patients could not detect a drop in blood sugar.

A Lantidra study cited by the FDA showed that 21 patients had been insulin-free for more than a year, and 10 participants had been insulin-free for more than five years. Five participants failed to achieve insulin independence for days.

Ninety percent of Lantidora users experienced at least one serious side effect to the drug. according to FDA package insert with detailed information for patients. The main causes of adverse reactions were the infusion procedure and immunosuppression, noted in the insert.

CellTrans Inc.’s seven-year exclusive marketing rights under the Orphan Drugs Act enable it to charge patients for treatment and reap huge profits. The company did not respond to multiple requests for comment from the Daily Caller.

Existing FDA regulations have significantly reduced the number of patients receiving islet therapy. according to of Island for U.S. Collaborative Research, a group of dozens of experts. Between 1999 and 2005, 176 patients with type 1 diabetes were given islet therapy, although islets may solve the patient’s hypoglycemia problem when insulin therapy is inadequate. , 11 in 2016-19.

FDA regulations have also jeopardized the safety of islet therapy, as the FDA’s Biological License Application (BLA) has stalled development in the islet field by impeding clinical use. claimed in April 2021 FDA Advisory Board meeting at published letter According to the peer-reviewed Journal of Clinical Medicine. CellTrans has submitted a BLA application for its islet therapy prior to the FDA meeting.

“The Food and Drug Administration (FDA) has regulated human islet transplantation as a biologic in the United States. The need for approval has stagnated development in the field for the past two decades,” the letter said.

“We have provided evidence that BLA requirements and drug-related regulations are inadequate to reassure the quality and efficacy of islet products, as well as patient safety and clinical outcomes,” the letter continued. there is

No tests are available to confirm the quality of the islets before transplantation, and Witkowski believes the quality of the drug is a hazard to consumers. (Related: FDA Commissioner Calls for Crackdown on Health Misinformation, Claims It’s Shortening Lifespan)

“The worst part is that the quality of this drug cannot be guaranteed. We are not even sure if the drug is sterile and designed to be injected into the patient’s blood circulation. How does this drug work?” I don’t understand why [been] It was approved without confirmation of sterility,” Witkowski said.

“Furthermore, the quality of the island [be] It has been objectively verified, and if it is ineffective, it cannot be verified that it was ineffective because the drug was of poor quality or for some other reason,” he added.

Transplant experts at Islets for US made similar claims about islet safety at the 2021 American Diabetes Association meeting. Report issued By Frontiers in Endocrinology, a peer-reviewed journal of endocrinology.

“We believe that FDA’s recent analysis of sponsor-submitted data in support of the BLA has revealed serious flaws in the current regulation of human islets that are of deep concern regarding patient safety and efficacy. (4, 5) In contrast to other approved biologics and cell therapies, islet sterility and Its effectiveness cannot be verified,” the report said.

“This contradicts the principles of the drug safety and efficacy regulatory system developed by the FDA. However, the FDA continues to demand that islets be regulated as a drug. In contrast to other countries, the United States has seen stagnant progress in this sector over the past decade,” the report continues.

FDA did not respond to the caller’s request for comment.