FDA Vows To Screen High-Risk Drugs
3 CommentsBy Ed Silverman // February 9th, 2010 // 8:15 am
To do so, the agency will use a new screening system to expedite importation of real meds and help inspectors focus their efforts on “high risk” products. Currently, customs officials examine a sliver of the 20 million shipments that reach US ports each year and that most inspections occur randomly.
The new web-based system is called Predict (Predictive Risk-Based Evaluation for Dynamic Import Compliance Targeting), and assigns a risk rating to drugs and other goods based on contents, supplier and point of origin. High risk imports are flagged for inspection, The Pink Sheet notes. You can watch a video here to see how things should work.
“Up to 40 per cent of the drugs (US citizens) take are imported” and “up to 80 per cent of the active pharmaceutical ingredients in those drugs come from foreign sources,” FDA commish Margaret Hamburg said in a speech at the Center for Strategic and International Studies. “Clearly, our nation’s traditional approach – relying on FDA inspections to catch problems at the border or in foreign facilities – needs a significant overhaul.”
Justice in MI/spellcheck
First, a spelling note–I think the Commish is Hamburg (not Hamberg) which kinda goes with the ketchup/catsup thread….
Re: the latter, my dad used to quote: “Shake and shake the ketchup bottle; none will come and then a lot’ll.”
…speaking of imported drug parts….
JaT
Can FDA really complain about counterfeit products or not trusting foreign products (they need to look at excipients too) when they are working toward “mininum standards” and allowing domestic (as if our drugs are made domestically) drug makers to alter their drug quality?
Maybe I’m misunderstanding the quality concept. How much has been devoted to this process now? Don’t they worry that they will be replaced by the WHO once those minimums are set?
http://www.pharmalot.com/2008/11/the-trouble-with-manufacturing-prabir-basu-explains/
I mean, you can’t redirect the process and then be surprized that it has created a new problem, as if it were inconceivable, while continuing to redirect the process.
JaT
Someone really should be providing me with an income for doing their job.