Posted on 06/03/2023 8:53:38 PM PDT by nickcarraway
-The U.S. Food and Drug Administration has given Qilu Pharmaceutical permission to ship cisplatin to the United States to ease a national cancer drug shortage.
-The drug maker’s cisplatin injections are manufactured and marketed in China. Cisplatin is widely used in chemotherapy to treat testicular, lung, bladder, cervical and ovarian cancers.
-The FDA earlier said it was considering allowing nonapproved drugs to be imported to alleviate the shortage.
The U.S. Food and Drug Administration has authorized the temporary importation of an unapproved chemotherapy drug from China in effort to ease an acute shortage of cancer drugs in the United States, according to an update posted to the agency’s website Friday.
Qilu Pharmaceutical, which makes and markets cisplatin injections in China, received FDA permission to export the drug to the U.S. market weeks ago, a document shows.
A letter dated May 24 from Qilu’s deputy general manager notified health care professionals of the approval.
Qilu is coordinating with a Toronto-based company, Apotex, to distribute 50-milligram cisplatin vials in the U.S.
Health care providers can begin ordering the drug Tuesday through their wholesalers.
Cisplatin is a generic drug that has been available for decades in the U.S. and is distributed by several approved manufacturers. Those manufacturers have been unable to keep up with demand. Qilu’s version of cisplatin is not approved in the U.S.
Qilu, which is headquartered in the city of Jinan in Shandong province, says it is one of the 10 largest drug manufacturers in China.
The FDA told CNBC this week the agency was considering imports of unapproved chemotherapy drugs, but it did not at that time disclose the names of any manufacturers who might provide that medication.
An FDA spokesperson said the agency assesses the quality of unapproved drug imports to make sure they are safe for U.S. patients.
Doctors say some cancer patients could die if the national shortage of drugs such as cisplatin is not resolved soon. At least 13 other cancer drugs are in short supply across the U.S.
The cancer drug shortages have forced some hospitals to ration medications by reducing the dosage to extend the supply and prioritizing patients who have a better chance of being cured.
Cisplatin is widely used to treat testicular, lung, bladder, cervical and ovarian cancers among other disease states. Up to 20% of cancer patients are treated with cisplatin and other platinum-based chemotherapy drugs, according to the National Cancer Institute.
The World Health Organization says the drug is an essential part of basic health care.
The national shortage of cisplatin began in February after a pharmaceutical company based in India temporarily halted production for the U.S. market.
Intas Pharmaceuticals decided to temporarily stop production after an FDA inspection last year found a “cascade of failure” in its quality control unit.
A spokesperson for Intas told CNBC this week the company is working with the FDA to restart production for the U.S., but no date has been set yet.
Didn’t Biden cure cancer? He said he would.
Weird.
That drug has been around a long time. Surprised we wouldn’t get it from India or Israel or Ireland.
(The alliteration was kind of a surprise to me.)
Maybe China offered the best price?
“ The cancer drug shortages have forced some hospitals to ration medications by reducing the dosage to extend the supply and prioritizing patients who have a better chance of being cured.”
What on earth?!!!
It sounds like the same play the FDA did with baby formula.
Shut down the main producer, keep them down for months.
And voila! A shortage.
Yep. This is what socialized medicine looks like, and you can bet this is happening because we get so many of our drugs and precursor chemicals from China. They’re withholding. I’m a pharma tech, and I’ve never seen such shortages of medications. From treating ADHD to antibiotics to insulin, epi-pebs and meds that treat frickin’ bowel cramping, we’ve had difficulty getting a lot of meds for patients.
Check this out...
The last paragraph...
“A spokesperson for Intas told CNBC this week the company is working with the FDA to restart production for the U.S., but no date has been set yet.”
There you have it.
So the ChiComs made God knows how much off muzzles.
Croaked our republic and economy with their virus.
Now the vaxxes are causing cancers and the ChiComs are making money off cancer meds...
Trump signed operation warp speed to give them all how much taxpayer dollars. Sickening isn’t it.
After Obama defunded hyperviralization in the US in 2014 as too dangerous.. I was thinking great.. I should have known it was too dangerous, it was potential leaking by someone with a conscious.
They renamed it gain of function to protect Obama and co.
I was told about a month ago that the carbon platin I was being treated with was in short supply and that what was available was set aside for patients “who could be cured” rather than just treated and improved. My metastatic esophageal cancer has been treated for six years with surgery, chemotherapy, and radiation therapy. I’ve beaten the odds on 5 year survival through good treatment and God’s grace. Hoping the new drug can be effective and get me a few extra years.
But production of life-saving meds is kind of an abstract concept until it is YOUR life-saving medicine.
Maybe the Big Guy can only get his 10% from China?
Just realized what this reminds me of...
That EUA for approved use of KN-95s in healthcare settings during the scamdemic.
Cui bono...
What if these are tests to determine how our economy responds to certain stimulus?
In unrelated news, egg shortage is over, prices are below what they were pre-”avian flu”.
On average, how long is it taking to get the meds in (if there is a shortage? A week? a month ?
90% of our pharmaceuticals come from China any questions about who control who now all thanks to seedy deals the money hustlers in D.C. has caused.
China is our friend
Joe Biden
Depends on the meds. Ozempic and diabetic drugs may take a few weeks, but stuff like generic Adderall - it’s months. Anything on backorder has an open ETA.
Children’s Tylenol and Motrin we haven’t had for over six months.
For the record, here’s the FDA shortages list:
https://www.accessdata.fda.gov/scripts/drugshortages/default.cfm
Disclaimer: Opinions posted on Free Republic are those of the individual posters and do not necessarily represent the opinion of Free Republic or its management. All materials posted herein are protected by copyright law and the exemption for fair use of copyrighted works.