FDA Lacks Funding, Staffing To Properly Regulate Pharmaceutical Compounders, Top Agency Official Claims
The agency is tasked with making sure that compounded drugs, which are made at facilities that don’t have to meet the same standards as regular drug manufacturers, are safe. Director of the Center for Drug Evaluation and Research Janet Woodcock says that her inspectors are seeing concerning problems, but lacks resources to be truly effective.
'Stuff Floating' In Compounded Drugs Prompts FDA To Appeal For More Funding
The Food and Drug Administration doesn’t have enough funding or staff to properly regulate pharmaceutical compounders, a top agency official said Friday, describing inspections that turned up “stuff floating around” in supposedly sterile shipments. The program doesn’t “have adequate core staffing,” said Janet Woodcock, director of the Center for Drug Evaluation and Research, on Friday, adding that it’s one of the center’s programs that is “suffering the most.” (Swetlitz and Florko, 9/21)
In other pharmaceutical news —
FDA Orders Pharma Lab To Shut Down In-House Microbrewery
There’s trouble brewing in the Chicago suburbs, where the FDA has served up another round of warnings to a pharmaceutical laboratory using its space to craft small-batch beer. A recent inspection of Pharmaceutical Laboratories and Consultants Inc., in Addison, Ill., found brewery supplies casually mixed in with equipment used to evaluate over-the-counter drug products. In one instance, the facility had stored a beer fermenter and created a workspace for a brewery employee preparing kegs, all within 10 feet of an area where microbiological material is kept. (Facher, 9/21)