http://www.nytimes.com/2012/10/07/us/scant-drug-maker-oversight-in-meningitis-outbreak.html
According to this article:
“To be sure, many compounding pharmacies perform well, producing formulations of drugs for specialized needs. Compounders have also provided hospitals and doctors with cheaper alternatives to F.D.A.-approved drugs.
For example, they are providing a far cheaper alternative to a drug called Makena, a new brand name version of an old drug used to reduce the risk of premature births. Once the drug got F.D.A. approval, the manufacturer of Makena began charging about a hundred times more for the drug than compounders. Officials from the F.D.A. wanted to ban the pharmacy-made versions on the grounds that Makena had met the agency’s rigorous safety standards, but senior Obama administration officials, concerned about Makena’s much higher price, stepped in to halt the ban.”
Did Hologic, Inc not make the right contributions or largest enough contributions to the right political party.. to get the Obama administration to instruct the FDA to allow compounding pharmacies to BREAK FEDERAL LAW without consequences? Is this how our healthcare payor system is going to “save money”?
Back in the early 70’s when Congress was debating MAC pricing for Medicaid… then FDA commissioner — Donald Kennedy — was quoted as telling Congress that medication quality was the most important thing… after Congress passed the MAC regulation… Kennedy’s was quoted as saying “… we can tolerate a variance in quality to maintain a price …” It would appear that we are headed down that slippery slope where price is the only thing that really matters… if people die… it is the cost of maintaining the cheapest price ?
The FDA did not act until the count of ILLEGAL on line pharmacies reached 10,000 before they decided to put together a “educational campaign”
We all know that the main purpose of career bureaucrats is to grow and entrench their respective bureaucracies …but.. has the total bureaucracy gotten so big that it is consuming an ever increasing amount of its own resources to serve its main purpose… to the point they can’t perform any other function ?
Filed under: General Problems
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