A Report Everyone Should Read

A Report Everyone Should Read

Yesterday the Food and Drug Administration released a report entitled “FDA Science and Mission at Risk”. The report was highly critical of the FDA and could be the first step towards desperately needed changes at the agency. Here are just a few items from the report:

“The Subcommittee concluded that science at the FDA is in a precarious position: the Agency suffers from serious scientific deficiencies and is not positioned to meet current or emerging regulatory responsibilities.”

“The FDA cannot fulfill its mission because its scientific base has eroded and its scientific organizational structure is weak.”

“The FDA cannot fulfill its mission because its scientific workforce does not have sufficient capacity and capability.”

“The FDA cannot fulfill its mission because its information technology (IT) infrastructure is inadequate.”

Many have suggested the agency receive additional funding to address its many issues. While Diabetic Investor doubts anyone would disagree with additional funding, the real question is will more money solve the problem. Washington has this way of throwing money at a problem thinking that more money will do the trick. As we have seen too many times in the past just throwing money at problem rarely works.

The fact of the matter is the demands of the FDA are ever more complex and only likely to get more so. One thing we have learned from the recent Avandia controversy is that approving drugs is just one responsibility of the FDA. It is equally important to monitor approved drugs once used by a broader patient population.

The same is true when it comes to medical devices. This is particularly true with the many devices used by patients with diabetes. It is well known that the next major advancement in insulin delivery will be a closed loop insulin delivery system. A system which will combine insulin pump and continuous glucose monitoring.

In the end Diabetic Investor hopes this report will lead to more than just additional funds. More funds are needed but it’s even more important these additional resources are used appropriately. A very wise man once said, “Money only solves the problems that money creates.”