
Originally Posted by
GeoFisher
You blame the companies for this........I'd LIKE to know the violations that FORCED the FDA to shut the plant in Ohio down.
Lots of stuff left out of this link to know the real culprit. It might be money, it might be profits, it MIGHT be over regulation.......who knows.
Specialty groups representing researchers and doctors who care for children with cancer say the methotrexate shortage began in December when production declined. That drop resulted primarily from Ben Venue Laboratories Inc. temporarily closing its factory in Bedford, Ohio, in November after federal inspectors said the company had not been properly maintaining equipment or promptly addressing defective product batches and sterility problems.
Besides making methotrexate, the factory was the sole source for Johnson & Johnson?s Doxil, a drug widely used for breast and ovarian cancer that?s not been available for new patients for months.
This outage was caused by the FDA, and you imply it is about profits.......I say NOT.....I say regulation.
The FDA says the main reason for the shortages is manufacturing deficiencies leading to production shutdowns. Shortages also are resulting from companies halting production of drugs with low profit margins, companies consolidating in the generic drug industry and supplies of some ingredients shrinking.
Yet the FDA's response, EVEN though they shut down the plant, ALSO blames the companies, and PROFITS........I say fix and resolve the regulations......Nothing is perfect in this world. While perfection is the goal......if this plant was shut down for some silly reason, then the FDA is to blame. I don't know.
Later,
Geo