XRF Applications Blog

Friday, June 6, 2008

Does their have to be a Pharmaceutical Crisis?

Tainted pharmaceuticals are killing Americans. Less expensive overseas pharma sources are flooding the USA with medications that have little or no quality control.  The Food and Drug Administration (FDA) is responsible for overseeing pharmaceutical research and quality control but they are hindered by foreign government’s objections and internal budget concerns.

A recent article by Justin Blum stated: “The agency received a ``wake-up call'' this year after the deaths of 81 people who took the blood thinner heparin, according to a top FDA official. The drug was contaminated by an ingredient from China. In fact, interviews with 10 former employees revealed that alarms about safety went unheeded for two decades, as imports soared. Documents show that FDA staff members raised concerns in 1988, 1991, 1993, 1996 and 2002.” ``It was no surprise,'' said Carl Nielsen, who retired in 2005 as the FDA's director of import operations and policy, referring to the heparin case. ``Especially when you consider how little FDA oversight there is.''.

As you can see for years, even decades, we have known about this potential threat. The Blum article continued:

A 1996 memo from the FDA's Forensic Chemistry Center about imported drugs warned that ``we have just scratched the surface of the problem of counterfeit drugs and will need considerable assistance in getting the problem under control.''

Nielsen, then in the FDA's Office of Criminal Investigations, cited the epilepsy drug case in a 1996 memo that described ``little or no FDA control of bulk drugs coming into this country'' and ``no ongoing enforcement action to serve as a meaningful deterrence to the trafficking and use of counterfeit or unapproved bulk drugs.''

Customs investigators and FDA officials concluded several years later that the defective ingredient came from an unidentified overseas country. The material, from an unapproved source, had been re-labeled to make it appear legitimate, Nielsen said.

The agency wasn't more vigilant because it had too little money and too many competing priorities, said William Hubbard, an FDA associate commissioner for policy and planning for 14 years before he retired in 2005. FDA commissioners, presidential administrations of both parties and Congress all bear responsibility, he said.

``The whole history of the FDA is that there's got to be a crisis before action will occur,'' Hubbard said.

The problem is clear, a struggling economy here at home, rising costs of drugs and with an aging population using more prescription medicines, it is no wonder the pharmaceutical industry has followed the path of every other major manufacturer in the USA by going overseas for it production needs.  From what we have read the FDA knows this but is unable to meet the need for inspection. 

One suggested method of pharmaceutical authentication is implementing an electronic pedigree (e-pedigree) system.  A frequently discussed method of e-pedigree for the pharmaceutical supply chain is Radio Frequency Identification (RFID) tracking.  By utilizing RFID, the pharmaceutical industry can monitor location of products as they move through the supply chain.

A true authentication system – one that could be used in correlation with RFID – is a non-destructive pharmaceutical testing instrument available from XStream Systems; the XT-250 offers an additional layer of pharmaceutical quality control.  This material identification system performs non-destructive testing of drugs while they remain in their sealed containers.  It can be used in the supply chain to spot tampered or counterfeit drugs before they reach the drug store, at the dock as they enter the country or at the pharmacy before counterfeit pharmaceuticals are handed to you or your family.

Additional information on the XStream System can be found here 
or contact Eastern Applied Research to discuss the various methods of pharmaceutical authentication to meet your needs at 716-625-8311.

We appreciate the informative article by Justin Blum that was referenced in this entry.  The entire article can be reviewed at:
http://bloomberg.com/apps/news?pid=20601109&sid=aphMT.TmocZM&refer=home

- BM

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