Contributed by Joanne C. Kelleher
I have written several entries about food and drug safety, RFID tracking and the FDA including:
- Food Production and Safety
- Safeguarding America’s Pharmaceuticals
- FDA Tracking Requirements: Drugs, Medical Devices, Why Not Food Too?
- RFID and ePedigree Won’t Help these Twists in the Pharmaceutical Supply Chain
After reading The Safety Gap by Gardiner Harris in The New York Times Magazine published on October 31, 2008, I am amazed the FDA has been able to accomplish what they have. How can we expect an agency that can’t maintain accurate databases or share collected information across their organization to successfully implement an automated tracking system, RFID or otherwise? How could they collect, manage and analyze the huge volumes of data that such a system would generate without a large budget increase to fund additional inspectors, computer systems and IT experts?
Here are some interesting sections of this story that highlight the conditions that the FDA is working under; I would recommend you read the entire article:
This year, 18.2 million shipments of food, devices, cosmetics and drugs are expected to enter more than 300 U.S. ports; the F.D.A. had 454 investigators in 2007 one and a half per port to scrutinize them. Theirs is an almost hopeless task, made even more frustrating by the inability of one part of the F.D.A. to share even its most basic information with another. Inspectors in Los Angeles, for instance, have no way of knowing which Chinese drug or device imports really ought to be reviewed because they do not have access to records of F.D.A. plant inspections. If the agents knew, for example, that an F.D.A. inspector had found significant problems at a particular facility, they could be sure to check for the maker’s name on a shipping manifest. But they have no way of knowing where to focus their attention.
Compounding the problem is the F.D.A.s antiquated technology. Its computer systems are so awful that officials have no way of knowing which names, or which plants, are real. To determine which factories need to be inspected, agency investigators must consult two incompatible databases, one of which lists 3,000 foreign drug plants exporting to the United States and the other 6,800. Which number is right? Nobody really knows. Officials have told House investigators that their best guess for the number of foreign drug plants exporting to the United States is 2,967, while the Government Accountability Office recently guessed 3,249. Neither can the agency tell in many cases when the plants were last inspected (or, more important, which have never been inspected), where they are located or what products they make.
Over the past six years, the F.D.A. has managed to inspect annually an average of just 15 of the 714 Chinese drug plants that export to the United States. At its present pace, the F.D.A. would need more than 50 years to visit all of these Chinese plants. By contrast, the F.D.A. inspects domestic drug plants every 2.7 years.
A 2002 law requires produce processors and distributors to keep track of where food goes and comes from, but the government has yet to mandate standardized record-keeping. As a result, in response to a scare, investigators must pour over a blizzard of contradictory packing slips and incompatible computer programs as they race to save people.
The article closes with a summary of the political situation the FDA has been dealing with in their quest for increased funding and a hope, which I echo, that there will be a policy change from the presidential administration, regardless of who wins the upcoming election.