May 27, 2023 Source: https://endpts.com/ 130
The US House of Representatives has turned a sharp eye to drug shortages over the past few months, with hearings and new caucuses to try and dampen the situation, but another bipartisan letter sent yesterday to FDA aims to keep the pressure up on cancer drug shortages.
Reps. Debbie Dingell (D-MI) and Tim Walberg (R-MI) penned the letter to FDA Commissioner Rob Califf, expressing concerns around the shortages of two commonly used chemotherapies used to treat cancer, known as cisplatin and carboplatin, which are used for lung, gynecologic and breast cancers, as well as methotrexate, which is used in treating other forms of cancer.
“These chemotherapy drug shortages come amid a shortage of other critical cancer medications. Taken together, they are straining the ability of doctors to provide the best course of treatment for their patients. We are hearing directly from impacted hospitals urging immediate action to address these alarming challenges,” the letter said.
The letter states that these shortages have stemmed, in part, from a halt in production at a manufacturing facility for India-based Intas Pharmaceuticals after several observations over quality were made by FDA inspectors late last year.
The representatives are requesting an immediate briefing from the agency on the situation and want answers to several questions, including how the FDA is working with manufacturers to mitigate the shortage of the drugs, whether will there be additional shortages of other chemotherapy drugs, what can the FDA do to help increase production of the drugs and when it expects the shortage to start to lift.
This shortage of cancer drugs has also concerned other members of the House, with Rep. Frank Pallone (D-NJ) issuing a statement last week expressing his concern over the situation and stating that his staff was working with the Biden administration and the FDA to address the shortages as well.
“I’m grateful that FDA is actively looking at all options to increase supply quickly. The agency is working with manufacturers to expand production of the drugs by expediting review of new manufacturing lines, facilities, and suppliers of ingredients,” Rep. Pallone’s statement said.
By editor
your submission has already been received.
OK
Please enter a valid Email address!
Submit
The most relevant industry news & insight will be sent to you every two weeks.