Comments on: Cough & Cold Maker Barred From Manufacturing http://www.pharmalot.com/2008/05/cough-cold-maker-barred-from-manufacturing/ News, Comment and Conversation Sat, 20 Mar 2010 21:33:14 +0000 http://wordpress.org/?v=2.6.2 By: Bruce http://www.pharmalot.com/2008/05/cough-cold-maker-barred-from-manufacturing/#comment-356921 Bruce Sat, 17 May 2008 00:53:50 +0000 http://www.pharmalot.com/?p=13669#comment-356921 This is exactly what needs to be stopped. Producing, marketing, and taking taxpayer money for unapproved and unlicensed meds is not fraud? Where are we...China? This is exactly what needs to be stopped. Producing, marketing, and taking taxpayer money for unapproved and unlicensed meds is not fraud? Where are we…China?

]]> By: Justice in Michigan http://www.pharmalot.com/2008/05/cough-cold-maker-barred-from-manufacturing/#comment-356902 Justice in Michigan Fri, 16 May 2008 17:24:50 +0000 http://www.pharmalot.com/?p=13669#comment-356902 Holy cow. Just read the complaint. In essence, these folks were manufacturing drugs essentially out of their garage. These were not "only" generic copies - some were "new." This is down the road from FDA in Maryland. FDA inspected the facility in 2006 if not earlier, and issued "compliance guidelines" (which were ignored). If this can happen down the road from FDA in Maryland, we should certainly not be surprised that what goes on in China and elsewhere may not "come to FDA's attention" - or, if it does, that anything significant will result very soon, if ever. Holy cow. Just read the complaint. In essence, these folks were manufacturing drugs essentially out of their garage. These were not “only” generic copies - some were “new.” This is down the road from FDA in Maryland. FDA inspected the facility in 2006 if not earlier, and issued “compliance guidelines” (which were ignored).

If this can happen down the road from FDA in Maryland, we should certainly not be surprised that what goes on in China and elsewhere may not “come to FDA’s attention” - or, if it does, that anything significant will result very soon, if ever.

]]> By: Justice in Michigan http://www.pharmalot.com/2008/05/cough-cold-maker-barred-from-manufacturing/#comment-356900 Justice in Michigan Fri, 16 May 2008 17:17:07 +0000 http://www.pharmalot.com/?p=13669#comment-356900 I don't know anything about this company, but this may be a good example of when preemption would not apply. As I read the summary, this company was never in compliance, failed two inspections, etc. Nonetheless, they were allowed to continue manufacturing drugs through this period. That said, it does not sound like DOJ is claming fraud (but I have to read complaint). Needless to say, fraud would apply if company did seek FDA approval in illicit way. Sounds like these guys mostly just blew FDA off. I don’t know anything about this company, but this may be a good example of when preemption would not apply. As I read the summary, this company was never in compliance, failed two inspections, etc. Nonetheless, they were allowed to continue manufacturing drugs through this period.

That said, it does not sound like DOJ is claming fraud (but I have to read complaint). Needless to say, fraud would apply if company did seek FDA approval in illicit way. Sounds like these guys mostly just blew FDA off.

]]> By: Dan http://www.pharmalot.com/2008/05/cough-cold-maker-barred-from-manufacturing/#comment-356890 Dan Fri, 16 May 2008 14:27:27 +0000 http://www.pharmalot.com/?p=13669#comment-356890 There are a few other companies besides this one who do this type of activity. Getting an NDC number is easy, and that's all that is needed to get a drug on the market. There are a few other companies besides this one who do this type of activity. Getting an NDC number is easy, and that’s all that is needed to get a drug on the market.

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