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A friend of mine with MS said there has been shortage issues with her meds as well.
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”.
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.
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