The Safety Gap

Today's N.Y. Times Magazine contains a frightening article about the about the challenges facing the FDA. The short version is the FDA is under-equipped, under-staffed, and under-capitalized to deal with the challenges of a Global economy. For example, the FDA's limited resources prevent it from adequately policing the very manufacturing sites where there are most likely to be problems. And even if inspectors do successfully audit a site, they rarely if ever are able to go back to follow-up. The article states:

"And when inspectors find dangerous conditions at domestic plants, they generally return promptly to ensure that those conditions get fixed. Not so in foreign plants. In a report released Oct. 22, government auditors reported that between 2002 and 2007, F.D.A. inspectors found dangerous conditions in 15 foreign plants. Only one of those plants was reinspected within two years, the auditors found. In every other case, the agency took foreign managers at their word that promised changes were made."

The article goes on to cite numerous examples that illustrate the issues and problems that the agency faces.

Bottom line...the Food and Drug Safety system in this country is broken and it desperately needs to be fixed.