Scant Oversight of Drug Maker in Fatal Meningitis Outbreak (NYTimes)
...some doctors and clinics have turned away from major drug manufacturers and have taken their business to so-called compounding pharmacies, like New England Compounding, which mix up batches of drugs on their own, often for much lower prices than major manufacturers charge — and with little of the federal oversight of drug safety and quality that is routine for the big companies.
“The Food and Drug Administration has more regulatory authority over a drug factory in China than over a compounding pharmacy in Massachusetts,” said Kevin Outterson, an associate professor of law at Boston University...
Was it Republican sponsored deregulation? That's not a certainty, but there is this:
The F.D.A. did develop a clear set of rules for compounding, but subsequent litigation that culminated in a Supreme Court decision in 2002 struck them down,
Now, while that would be the Scalia/Rehnquist court, in fact the decision in
Thompson v. Western States had Souter joining the evil 5, with Rehnquist actually leaving them in support of Breyer's dissent along with Stevens and Ginsburg. Not sure of the legal questions therein, but no matter:
[One of the medical practices purchasing the drug] paid New England Compounding $25 for a vial containing five 80-milligram doses. A similar vial of the Depo-Medrol by Pfizer, with the alcohol preservative, costs about $40 to $46, according to the Web site of Clint Pharmaceuticals, a distributor.
Hmmm. Do you think that alcohol preservative prevents contamination of the drug over time? And that lack of it in the cheaper drug is what allowed the fungus to grow in it and
kill 7 and infect 65?
Using the figures cited above the savings per dose works out to $4 each. Is a life worth just $4.00?? Well, as A Bain Capital number cruncher might think of it- a $4 savings on 100 patients per week (an actual number cited in the article) works out to $400/week, or $20,000 year. Now who would do such heartless calculation?
Was it Republican sponsored deregulation? We can't say for sure yet, but history has shown us all too often where Republicans and Democrats tend to stand on such issues.
And this story line is getting to be way too predictable.
Sadly. Tragically.
4:22 AM PT: Hold on all you folks who think this is NOT an issue of deregulation.
Please focus on this one simple fact of the story: Why was the compounder allowed to produce the drug WITHOUT THE PRESERVATIVE (in this case alcohol) ? Lack of which allowed the fungus to grow in storage.
Yes that's right- it was a LACK of regulation. and of course, THAT'S why we have REGULATIONS!!!!