Allan Holmes pointed me to a recent story in the Congress Daily. It seems that Edward Kennedy, D-Mass., who chairs the office of Senate Health, Education, Labor and Pensions Committee Chairman circulated on Monday a list of options for strengthening drug and device safety that are being considered for inclusions in legislation Kennedy's panel is reviewing to improve FDA oversight.

The recent contamination problems with foreign produce heparin that is believed for the deaths of 81 persons in the US as well as chemical-tainted wheat gluten in pet food have been major drivers for strengthening the FDA's oversight capabilities.

The story goes on to say:

The options include charging industry registration fees to fund more FDA inspections of drug and device plants and requiring the agency to inspect foreign drug firms as often as domestic ones.

Those and many of the other provisions are similar to ones proposed by House Energy and Commerce Committee Chairman John Dingell, D-Mich., but unlike Dingell's, one of the Senate options includes giving FDA the power to base its inspections on risk.

At a House hearing on the Dingell proposal last week, Janet Woodcock, FDA's drug center director, stressed the need for the agency to spend its resources as it sees most fit. Some consumer advocates are wary of a risk-based approach, but Woodcock also admitted companies should operate under the impression they will be inspected on a regular basis.

In Woodcock's testimony, she said, "Any legislation should allow FDA to set requirements and priorities based on a strong scientific FDA risk assessment."

That is, I believe, a sensible approach, but as pointed out last November by Bart Stupak, D-Mich., chairman of the Oversight & Investigations Subcommittee, in a hearing on the FDA Foreign Drug Inspection Program, the FDA does not have the requisite data to begin to make good risk assessments.

Stupak pointed out, for instance, that despite more than a decade of warnings from FDA’s own internal reviews, Congress, and the Government Accountability Office, FDA’s IT system is still based on multiple databases which lack integration and contain unreliable information.

In addition, due to these poor IT systems, the FDA cannot obtain reliable data to run their risk models so they can effectively allocate what limited resources it does have for inspections.

Stupak asked a question that I have yet to see completely answered by the FDA: How can anyone have any confidence FDA is truly managing the risk that may come from foreign-made drug products if the FDA does not know the exact number or location of foreign drug manufacturers?

It's nice to say you are going to have a risk-based approach to best allocate your scarce resources, but without the data, the exercise turns into little more than gambling.