The Debt Crisis and the FDA

The Debt Crisis and the FDA

While our elected officials do their best to ruin the credit rating of the United States, the debate going on in Washington has wide ranging implications for the FDA. As we noted yesterday the FDA is once again expanding their oversight responsibilities to include mobile health apps. This expansion of their regulatory oversight comes at a time when the agency can barely perform their existing functions.  It also comes at a time when the agency is begging for additional funds to handle their growing list of responsibilities. Herein lies the problem, at a time when the agency is expanding their role the government is getting set to make major cuts to the budget.

Although no one knows how the debt crisis will be resolved, one thing is pretty clear budget cuts will be part of the package. It’s also pretty clear with our divided and dysfunctional Congress that it will be difficult if not impossible for any tax increases to become part of the package.  Without any revenue enhancements simple math tells everyone that our government will be asked to do more with less money. Although Diabetic Investor is not an advocate of tax increases, almost every expert on the economy has stated that changes to the tax code would yield greater revenues without hurting the economy.

This situation becomes more complicated when looking at the options available to the FDA. Understanding that they will not see additional funds and could actually face budget cutbacks, the agency basically has two choices- cut back the services they perform or charge more for these services in the way of fees paid by drug and device companies – a third possibility would be a combination of the two approaches.

No matter which option the agency choses the implications are not promising. The drug and device approval process, already painfully slow, would likely take even longer. Drug and device companies would likely see their regulatory costs increase in the way of higher fees paid to the agency. Ultimately patients would suffer the most as they would not have access to new drugs and devices.

It should also be noted that just as the FDA will be asked to do more with less, this same scenario will play out for NIH. At time when every disease state is seeking more research dollars those dollars just aren’t there. This places a greater burden on organizations like the ADA and JDRF, two organizations that due to the economy are finding donations harder to come by. The simple fact is research costs money and many worthy projects will never see the light of day due to lack of funds.

Not that any of this seems to matter to our elected officials who are more concerned with playing politics rather than actually solving the problem. And has become standard operating procedure it is the American public who will pay a heavy price for their stubbornness.

Robert Kennedy during a Senate speech back in 1966 stated; “A revolution is coming – a revolution which will be peaceful if we are wise enough; compassionate if we care enough; successful if we are fortunate enough – but a revolution which is coming whether we will it or not. We can affect its character; we cannot alter its inevitability.”  Let’s hope for all concerned that the members of Congress and the President come to their senses and that this coming revolution makes America stronger. The stakes are as enormous as our level of debt.