Cough & Cold Maker Barred From Manufacturing
4 CommentsBy Ed Silverman // May 16th, 2008 // 10:18 am
Scientific Laboratories and its two top execs - ceo Amit Roy and president Rajeshwari Patel - have signed a consent decree and are barred from manufacturing and distributing prescription meds until they bring their operations into compliance and obtain FDA approval for their products.
The company, which is based in Columbia, Maryland, and is a contract manufacturer and distributor, failed to seek required FDA approval for some of its products and failed to comply with current good manufacturing practice requirements, according to the complained filed by the Department of Justice. Scientific Labs failed several FDA inspections between 2005 and 2007, according to the complaint.
The unapproved cough and cold drugs include: B-Vex Suspension, Ben-Tann Suspension, D-Tann Suspension, D-Tann AT Suspension, D-Tann CT Suspension, D-Tann DM Suspension, D-Tann HC Suspension, Dur-Tann DM Suspension, Duratan DM Suspension, L-All 12 Suspension, Nazarin Liquid, and Nazarin HC Liquid. The FDA says safety and effectiveness was never established.
Dan
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.
Justice in Michigan
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.
Justice in Michigan
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.
Bruce
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?