Normally I try to avoid the ol' VS forum anymore, but I must say as someone working in the pharmacy industry the FDA did drop the ball here, at least in part. In fact the only other agency that comes off looking more idiotic in this situation is perhaps the Massachusetts Board of Pharmacy.
The FDA along with many others deserve to be grilled over this. Hamburg can play the role of the powerless, but the major failure was their failure to acknowledge NECC as a drug manufacturer despite the fact that mass produced medications for the majority of the lower 48. As a compounding pharmacy you must first have a written order or valid prescription for a patient patient before sending the medication to it's end destination. The FDA was warned by various people, regulators, and agencies around the US that they were distributing mass quantities without those prescriptions or orders. Yet the FDA never took notice to them as a manufacturer? Hell that alone violates various FDA regulations on sending medication out of state.
Also read the hearing on the website and it's plain to see she was being pretty evasive on some questions. When asked directly if she thought the FDA had authority to shut down the NECC's operations, Yes or No. Her response was that it was a "very, very complex question". Dodge... Some of the answers to questions regarding regulation she was also very hazy on. Take this quote:
"We have to figure out how to give you the jurisdiction to do what you need to do, OK?" said Rep. Diana DeGette (D-Colo). "And these inconclusive answers are not helping us."
Yeah that was a D next to that name. And her opening speech was just odd in my opinion, she somehow split pharmacy compounding into 2 categories (which granted I don't have a long career yet but I've never heard the names traditional & non-traditional before now) yet did not clearly define them.
There's also the larger point that the FDA has had growing concerns about NECC and operations like it for nearly a decade, why not bring up the extreme and apparent need for this addition regulation before now?
My overall point is that yes some regulation is needed and the same old partisan crap never gets anything done correctly. Every pharmacy compounds medications and many pharmacies even do sterile compounding however few do it on such a large scale. The company I work for we do maybe 5-10 sterile compounds per day and that's out of usually 900-1000+ physician orders per day and it's an average size operation to be honest and there are probably hundreds across the US like this. So I do not see the FDA regulating even pharmacy doing sterile compounding at least not in a practical way.
Still the rule IMO should be simple, if you produce and ship X number of medications per year then you are without a doubt a manufacturer and welcome to FDA regulation land. If you ship drugs across state lines without the proper orders you are a manufacturer and welcome again to FDA regulation land, etc., etc. There's really no need to read on and on for 20mins about categories that don't exist (FDA, Hamburg) or use a hearing to bicker over which political party gets to point fingers at each other (Congress). Just fix the issue so dozens of people don't die slow, agonizing deaths again.
if the head of the FDA cares about me as long as she protects me from the law-breaking cost-cutting quacks and hacks in the pharma biz. At least the D rep had the goal of trying to fix the legislation while she berated the bureaucrat. 