Posted on 06/24/2011 4:40:12 PM PDT by Nachum
The Food and Drug Administration is notoriously allergic to the concept of tradeoffs: FDA bureaucrats see eliminating risk as their highest goal, no matter what benefits might be destroyed in the process. This tendency has manifested itself most tragically in the current drug shortage.
About 150 drugs considered “medically necessary,” including anesthetics and medications that treat lethal illnesses such as leukemia, are today in shortage. This problem has been growing since at least 2005, and there are several causes for it — but overly stringent FDA regulations are one reason it has reached such immense proportions.
Since the “tainted drugs” crisis that incited a media panic a few years ago, the FDA has made its quality-enforcement policies far more burdensome, stepping up its “Good Manufacturing Practice” rules, as well as its efforts to regulate drugs that were introduced before 1938 (and thus grandfathered out of regulations). Thanks to the FDA’s zero-tolerance enforcement, any drug manufacturer that participates in the U.S. market has to pass inspections with flying colors; otherwise, entire production lines are shut down for retooling.
(Excerpt) Read more at nationalreview.com ...
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A friend of mine with MS said there has been shortage issues with her meds as well.
Sorry to hear. How is she solving her problem?
Working in the industry this quote: “Thanks to the FDA’s zero-tolerance enforcement, any drug manufacturer that participates in the U.S. market has to pass inspections with flying colors; otherwise, entire production lines are shut down for retooling.” isn’t 100% factual, if you don’t pass an inspection “with flying colors” there are many levels that you go through before being shut down. Even then there is the option of a consent decree, wherein the FDA signs off on anything going out the door. Hell the Red Cross has been under a consent decree for over a decade, but they still ship out their blood.
That being said they HAVE been making it much more difficult to accomplish anything and the drug world’s requirements are much more stringent than devices.
Part of the problem, in my wonderfully individual opinion, lies in the basic statistical idea that you cannot prove a negative. You can prove the positive is not true, but you cannot prove the negative. So for example if you test a sample of product - even if it passes, you can’t prove it is clean; only that the sample was clean or that it was within the statistical boundaries to say it was clean....no matter how much you tighten those limits there will always be at least an infinitesimal chance that something was missed. Proving it’s dirty is easy - just need one little test to fail - doesn’t matter why either. It’s similar to the idea you cannot prove god does/doesn’t exist.
For what it’s worth.
Old America used to never have “shortages”.
We haven’t spoken about it in a lot of detail. But, she receives infusions on a regular schedule and the staff told her about it. She’s still getting the infusions, hopefully they will continue on schedule.
Agree... Now its all about control an authority etc...
Going to get a lot worse before it gets better IMO.
Stay Safe..
The FDA always points to the horrible birth defects caused by pregnant women taking thalidomide as justification for their “thoroughness”. However, the ONLY reason that US women did not get thalidomide is because the bureaucrats were sitting on their lazy fat asses and not doing their jobs.
Another possible angle on this...Pharmaceutical Mfgr’s are unloading questionably unprofitable product lines in anticipation of ObamaCare. These lines are going overseas and we are now in import/export situations as well as NDA status with the FDA.
They had to switch my water pill to a different brand, which didn’t work as well..doc just upped the dosage to make up the difference.
FDA rarely removes drugs that have 50% failure rate due to horrendous side effects either.
Look up the side effects on those cholestrol drugs. http://www.mayoclinic.com/health/statin-side-effects/MY00205
Lyrica...50% failure rate, and the ‘disclosure’ on TV barely touches what damage these 2 drugs alone cause.
http://www.emedicinehealth.com/drug-pregabalin/article_em.htm
What they don’t mention is the sexual disfunction issue, or weight gain, or that it attacks all the Osteo A joints with extreme pain.
I know about side effects that are ignored by the FDA. I took some Avelox and suffered SEVERE psychological side effects.
1 lunesta, rotten copper taste in my mouth for 3 days, and anger so intense the next morning that it was scary. It was anger beyond any I had ever felt before and that includes when Jeremy was murdered.
Threw the crap in the trash.
Doc wants me to take one of those cholesterol drugs...with both fibromyalgia and Peripheral neuropathy, even the mildest would leave me in intense pain and or destroy my muscles. He can yap all he wants about the LDL, I refuse to take what I know could kill me.
They ignore a lot of drugs side effects. And some of the generics have side effects the name brand do NOT have. My name brand Synthroid is side effect free. Generic doesn’t work as well and causes ulcers in my mouth, and if I’d taken it beyond the few days I took it, my hair would have started falling out, along with the hypothyroid symptoms growing worse.
I received a kidney transplant 3 years ago, and with my immune system suppressed, the BK virus in my urinary tract reactivated (the vast majority of people have this; a normal immune system keeps it suppressed, but when the immune system is suppressed, it sometimes reactivates, potentially damaging the kidney).
I’ve been taking Leflunomide to inhibit the virus, and the virus is almost undetectable now. However, my pharmacy has it on “backorder”, and I may be unable to get it in the very near future (our local Wal Mart has a limited supply).
Drug Shortage Resource Center: http://www.ashp.org/shortages
A lot of generics are now coming from China.
Interesting source. Thanks.
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